Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia and Israel. The company currently employsover 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: We are seeking a dynamic and experienced Associate Director or Senior Internal Audit Manager to support the growth and maturity of its global internal audit function. Based in Dundalk, Ireland, this role will work directly with the Internal Audit Director to lead audits across WuXi Biologics operations primarily in Europe with global exposure. This position offers a strategic opportunity to collaborate with global teams in China, Germany, and the US, while helping to shape and enhance internal controls, risk management, and compliance within a high-growth, innovation-driven environment. Department Description As an Internal Audit Lead (Associate Director), youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role, youll be reporting to the Internal Audit Director. Your Responsibilities Plan, lead, and execute audits across functional and operational areas. Ensure audits are performed in accordance with internal audit standards and global best practices. Conduct risk-based assessments, identify control gaps, and recommend practical improvements. Evaluate compliance with internal policies, regulatory requirements and industry standards. Draft clear and impactful audit reports with actionable recommendations. Present findings to local and global management, promoting accountability and remediation follow-up. Work closely with internal audit colleagues based in China, Germany, and the US to ensure global alignment and knowledge sharing. Support cross-regional audits and harmonization of audit methodology. Participate in advisory projects, risk assessments, and process improvement initiatives. Serve as a trusted partner while maintaining objectivity and independence. Your Profile Experience 810 years of audit experience, ideally with a combination of Big 4 and internal audit in a multinational environment. Solid understanding of internal controls, audit methodology, and regulatory frameworks. A strong Gemba-orientation from a lean management perspective. Fluent in English; additional languages (e.g. Chinese or German) are a plus. Willingness to travel globally (~10-20%) as needed. Qualifications Bachelors or Masters degree in Accounting, Finance, Business Administration, or a related field. Professional certification such as CIA, CPA, CISA, ACCA, or equivalent strongly preferred. Behavioural Competencies Strong analytical, communication, and interpersonal skills with the ability to influence stakeholders. Ability to manage multiple priorities and work independently with minimal supervision. Dynamic in approach and able to handle conflict. Ability to operate in a fast-moving, ever-changing environment and effectively deal with difficult situations. Self-motivated with excellent communication and interpersonal skills. Quick study who can rapidly adapt to Wuxi Biologics culture and gain the confidence of the organisation. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision -Any drug can be made, and any disease can be treated- dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! WuXi Biologics is an equal opportunities employer. Skills: Audit Big 4 internal controls regulatory frameworks gemba'-orientation Benefits: Bonus Life Assurance Paid Holidays Parking VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: As a QC Microbiology Senior Scientist, you will be leading various technical projects/activities in the QC Microbiology Group of WuXi Biologics. The site is focused on startup activities involving commissioning and qualification work with aggressive timelines and potential candidates are required to be flexible in this regard. This also means that potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description As a QC Microbiology Senior Scientist, youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role, youll be reporting to the QC Microbiology Associate Director. Essential Duties and Responsibilities Specific Start up activities: Ensure the tasks associated with the startup and routine operations of a QC microbiology laboratory are carried out in a safe manner. Support QC Microbiology lab set-up, including laboratory design and construction queries, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs. Microbial organism identification, supporting facility qualification, cleaning validation, process validation, etc. Develop and maintain quality systems within the QC Microbiology Laboratory to ensure compliance to cGLP. Support of the commissioning/qualification activities of utility systems including but not limited to Water systems, Clean Steam and process gases, including development of sampling strategies. Aiding in the identification and development of Contract Test laboratories and strategies. Development of training material for the QC Microbiology Laboratory personnel. Support and lead microbial method validation and development of routine testing strategies. Sustaining operations: Lead QC microbiology routine testing, environmental monitoring, water monitoring, and testing including sterility, endotoxin, bioburden, Biological Indicators, Growth promotion and routine microbial identification strategies. Routine monitoring of laboratory KPIs, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects. Serve as a technical expert to lead OOS, OOL, microbial contamination, adverse trends, utility and environmental excursion investigations, change controls, and CAPAs. Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc. Support Risk Assessments for projects and business innovation initiatives from a microbiologicalperspective. Defines specific aseptic techniques to be performed for crucial process steps and provides meaningfulinput to processing operations as site develops. Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratoryoperations and aseptic manufacturing. Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and AnalyticalDevelopment. Develop and maintain high level of scientific achievements for the company; expected to be a point ofcontact for project coordination, including email and client meetings. Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as wellas internal audits. Participate in relevant internal and external QC related audits. Ability to work in a team environment and independently as required Perform job specific tasks in compliance with applicable Regulations, International Standards, andWuXi Biologics Policies and Standard Operating Procedures. Thorough understanding of current Good Manufacturing Practices Perform all duties in accordance with GMP requirements, SOPs and controlled documents Flexibility to take on additional tasks and responsibilities at the discretion of the QC MicrobiologyAssociate Director Will act as a role model for the QC function and also the wider organisation in adherence to the WuXicorporate core values and PROUD culture. Person Specification Technical Competencies Possesses detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment. Familiarity with Pharmacopeia testing methods and requirements. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines is a plus. Experience with regulatory/customer audits is a plus. Experience Management/supervision of personnel with particular attention to schedules and shifting priorities. Training/coaching of personnel. Experience with direct manangement of staff is a plus. Previous experience in a Quality Control/GMP environment is required. Knowledge Knowledge of microbial testing and microbial control in support of biopharmaceutical manufacturing is preferred but not required. Qualifications Ph.D. with/without post doc experience or MS in Microbiology or related field is desirable Minimum of an honours science degree in a related field with 5+ years relative experience is essential. Behavioural Competencies Ability to think critically and demonstrate troubleshooting and problem solving skills Excellent interpersonal, verbal, and written communication skills Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities. Onerous requirements Shift work and business travel may be required for this position as directed by departmental management. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision -Any drug can be made, and any disease can be treated- dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us ator contact us via WuXi Biologics is an equal opportunities employer. Skills: Microbiology Sterility Testing Bioburden Endotoxin Audits Benefits: Work From Home Bonus Life Assurance Paid Holidays Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.The company has sites/offices in China, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: Your Responsibilities Key member of the QC leadership team for WuXi Biologics Ireland. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution. Work closely with all senior leaders to ensure work practises and targets are achieved in line with the business targets and objectives. The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the local site QC organisation. From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance. Develop/build a world-class Biologics QC bioassays and biochemical assays product-testing team, including planning, recruiting/hiring, coaching/mentoring, and training for 15-20 total headcount. Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations. Interact with internal and external partners, clients, and inspectors and maintains high quality standards and services Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations Prepare, review, and approve technical documents including method protocols, qualification and validation protocols and reports, etc. Serve as a technical lead supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs. Lead the group to meet the pre-determined goal/budget of the department through streamlining/optimizing the workflow and maximizing the operation efficient while maintaining full compliance Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings. Introduce new technologies and seek opportunities for continuous process improvements/improved operational excellence Ensure QC staff receive appropriate GMP training and maintain compliance and high quality standards Create a safety culture, enforce safety measures and ensure QC staff working in a safe environment Ability to work in a team environment and independently as required Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner Enhance collaborations by sharing knowledge and experiences across WuXi Biologics global sites Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Director. Will act as a role model for the QC function and the wider organisation in adherence to the WuXi corporate core values and local site shared commitments/behaviours. Person Specification Technical Competencies Ideally, experienced in establishing a QC function and building a team in a greenfield context of similar size and scale. Technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including cell based bioassay, PCR, ELISA, enzyme activity, Western Blot, SDS-PAGE, etc. to support QC release and stability testing in a GMP-environment according to USP, EP, and ChP requirements. Ability to handle regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance. Experience 15+ years working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential. Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required. Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project Management/supervision of personnel with particular attention to schedules and shifting priorities is required and demonstrated leadership skills Previous experience in a Quality Control/GMP environment is required Previous experience with regulatory inspections and internal/customer audits is strongly preferred Previous experience working in a CMO is a plus. Knowledge Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals. Qualifications University degree in related science/quality discipline required. Ph.D. with 5-8 years of experience, or Masters with 7-10 years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or another related field, desired. Behavioural Competencies Excellent interpersonal, verbal, and written communication skills Able to think critically and demonstrate troubleshooting and problem-solving skills Self-starter and self-motivated; organized with good attention to detail Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities Results oriented, with the ability to manage multiple priorities in a short period of time Skills: QC Tech transfer Validation Stability testing GMP Audits Benefits: Work From Home Bonus Laptop Life Assurance Paid Holidays Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: Your Responsibilities Key member of the QC leadership team for WuXi Biologics Ireland. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution. Work closely with all leaders to ensure work practices and targets are achieved in line with the business targets and objectives. The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the local site QC organisation. From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance. Provide the highest quality microbiological support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations. Key responsibilities will include: Leading a large QC microbiology laboratory to support all micro activities associated with bio manufacturing process. Ensure all resources are planned to ensure consistent support to day-to-day activities. Management of micro testing including bioburden, sterility, endotoxin, water/chemical testing, microbial organism identification testing etc. Support of microbiology methods associated with raw material, in-process and release testing. Facility, utilities and laboratory equipment qualification. Cleaning and process validation support. Development and review of environmental and utilities trend reports and provide relevant technical support and guidance. Leads all QC micro activities associated with method transfer, validation, and troubleshooting Develop KPIs for the QC microbiology lab and report regularly on metrics, identify associated opportunities for improvement as necessary. Provide technical expert in all environmental and micro investigations including microbial contamination and adverse trends utilising an established CAPA process this will include out of spec (OOS), deviations, change controls through prescribed validation process. Ensure all analytical protocols, policies and procedures are developed and adhered to Support the development of specific aseptic techniques and microbiology awareness and provides meaningful input to processing operations in collaboration with other functional areas. Perform and participate in any required Quality Risk Assessments for projects and business innovation initiatives from a microbiological perspective. Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations In conjunction with manufacturing, help improve training related to microbiological hygiene and contamination prevention Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development. Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits. Anticipating and planning for future requirements in both Manufacturing and the QC area Lead the group to meet the pre-determined goal/budget of the department through streamlining/optimizing the workflow and maximizing the operation efficient while maintaining full compliance. Introduce new technologies and seek opportunities for continuous process improvements/improved operational excellence. Ensure QC staff receive appropriate GMP training and maintain compliance and high quality standards Create a safety culture, enforce safety measures and ensure QC staff working in a safe environment. Ability to work in a team environment and independently as required. Perform all duties in accordance with GMP requirements, SOPs and controlled documents Flexibility to take on additional tasks and responsibilities at the discretion of the QC Director Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Person Specification Technical Competencies Ideally, experienced in establishing a QC function and building a team in a greenfield context of similar size and scale. Technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including Bioburden and endotoxin testing, sterility testing and microbial identification, etc. to support QC release and stability testing in a GMP-environment according to USP, EP, and ChP requirements. Demonstrating direct experience as QC Micro Lead in regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance. Experience Demonstrated strong experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics manufacturing industry is preferred. Experience leading a large team of QC professionals during startup is preferred and sustaining phase a key requirement for this role is essential. Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required. Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project Managing and leading a group of employees with particular attention to schedules and shifting priorities is required and demonstrating leadership competencies. Demonstrate Microbiology SME within a Quality Control/GMP environment is required Previous experience working in a CMO is a plus. Knowledge Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals. Possesses detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment. Qualifications University degree in related science/quality discipline is required. Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology is preferrable qualification, other related and equivalent qualifications will be considered. Behavioural Competencies Excellent interpersonal, verbal, and written communication skills Ability to think critically and demonstrate troubleshooting and problem-solving skills Self-starter and self-motivated; organised with good attention to detail Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities Results oriented, with the ability to manage multiple priorities in a short period of time Skills: Microbiology Tech transfer Validation Sterility Audits GMP. Benefits: Bonus Laptop Paid Holidays Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 10,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Supply Chain Management (SCM) and Warehouse (WH) QA Senior Manager The Supply Chain Management (SCM) and Warehouse (WH) QA Senior Manager will play a key role in supporting supply chain and warehouse functions to ensure the highest standards of professional excellence and quality assurance in the business, with responsibility for supporting the Pharmaceutical Quality System (PQS) in place, adhering to all regulatory, cGMP and company requirements and ensuring all necessary plans and standards are achieved by consistently maintaining a high level of quality via directly supporting and as a leader for SCM and WH QA Team. This role is critical in releasing materials, key consumables and DS batch release via the review and approval of dispensing records. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU and Asia. We currently employ over 10,000 people and provide services to more than 200 customers worldwide. Department Description As Supply Chain Management (SCM) and Warehouse (WH) QA Senior Manager, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the QMS Lead. Your Responsibilities: Lead the SCM & WH QA team providing quality monitoring and online QA oversight to Warehouse and SCM including dispensing operations. Ensure that warehousing, dispensing, shipping and other operations, as applicable, are conducted according to appropriate cGMP behaviours and compliance to SOPs and other cGMP documentation, as applicable. Supervise direct reports on a day-to-day basis, provide training and communications, assignments and prioritization of work. Ensure compliant release of GMP materials and key consumables. Ensure proper review and execution of dispensing records as prerequisite for DS batches certification by the qualified person (QP). Manage abnormal materials process and disposition. Review and decision making for receiving inquiries raised by WH team. Approval of materials and DS shipments ensuring correct status and conditions for shipments. Management of all rejected and quarantined materials. Leading quality monitoring and oversight program for SCM and WH teams. Oversee dispensing cleanroom status and recovery process. Responsible for electronic data review where related to DS baches storage and release. Manage performance, delivery of objectives and career development of direct reports. Provide QA review and approval of SOPs, quality risk assessments, change controls and other documentation, as applicable, associated with Warehouse and SCM. Liaise with Warehouse, SCM and QC teams, as appropriate, to ensure that all deviations, investigations and dispensing review comments are adequately addressed and closed out in a timely manner as defined in SOPs. Work with Warehouse, SCM and QC teams, as appropriate, to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to warehousing and SCM are addressed and closed out in the required time frame. Liaise with Warehouse, SCM, Manufacturing, QA, QC, etc. in supporting daily operations. Ensure clear communication on issues and timely escalation as applicable. Identify and drive opportunities for continuous improvement. Coordinate with internal Quality peers to ensure on-time disposition of drug substance materials. Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions. Collaborate internally and also across the WuXi network to achieve quality goals. Lead and/or represent QA on multidisciplinary teams, as required. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Deputize QMS Lead whenever delegated. Will be flexible to take on additional tasks and responsibilities at the discretion of the QMS Lead. Will act as a role model for the Quality Assurance function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile: The ideal candidate for this position will have the following: Education: Preferable that the individual has qualification Degree in Biopharmaceutical/ Pharmaceutical Science or other related science discipline. Knowledge/Experience Required: More than 8 years experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or QC or Warehouse & Distribution (GDP) or Manufacturing Operations within the biopharmaceutical/ pharmaceutical industry. Experience of leading teams would be an advantage. Experience working on QA/QC incoming material inspection or warehouse operations would be advantage. Experience working with SAP would be an advantage. Experience in performing internal audits would be an advantage. Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Demonstrated knowledge of good storage and distribution practices. Demonstrated knowledge of risk management and materials qualification. Personal skills Preferred: Proven decision-making capabilities. Demonstrated collaboration, negotiation, conflict resolution skills and inclusive approach with a teamwork mindset. Analytical, problem solving & root-cause analysis skills Able to challenge the status quo with a continuous improvement mindset. Excellent interpersonal, verbal, and written communication skills Self-starter and self-motivated; organized with good attention to details. Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities Results oriented, with the ability to manage multiple priorities in a short period of time. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! Apply now! Would you like to know more before you apply? Please visit us at or contact us via Skills: Dispensing Compliance Warehouse Quality Benefits: Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: As Senior QA for QC Specialist, you will play a key role in supporting the QC function to ensure the highest standards of professional excellence and quality assurance in the business, with responsibility for supporting the Pharmaceutical Quality System (PQS) in place, adhering to all regulatory, cGMP and company requirements and ensuring all necessary plans and standards are achieved by consistently maintaining a high level of quality. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description As Senior QA for QC Specialist, youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting to the QA for QC Senior Manager. Essential Duties and Responsibilities Ensure that QC functions, as applicable, are conducted according to appropriate cGMP behaviours and compliance to SOPs and other cGMP documentation, as applicable. Ensure that EudraLex GMP guidelines and all applicable cGMP guidelines are followed. Provide QA review and approval of SOPs, quality risk assessments, change controls and otherdocumentation, as applicable, associated with QC functions. Review and approval of QC and analytical data sections within the different documents e.g. Annual Product Quality Review, Quality Agreements, Service Level Agreements, etc. Act as SAP Key User for QM functions. Liaise with QC teams, as appropriate, to ensure that all deviations, investigations and dispensing review comments are adequately addressed and closed out in a timely manner as defined in SOPs. Work with Warehouse, SCM and QC teams, as appropriate, to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to QC and sampling operations are addressed and closed out in the required time frame. Liaise with key stakeholders in supporting daily operations. Ensure clear communication on issues and timely escalation as applicable. Identify and drive opportunities for continuous improvement. Coordinate with internal Quality peers to ensure on-time disposition of drug substance material. Provide support for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions. Perform all duties in accordance with cGMP requirements, SOPs and controlled documents. Deputize the QA for QC Senior Manager whenever delegated. Will be flexible to take on additional tasks and responsibilities at the discretion of the QA for QC Senior Manager. Will act as a role model for the Quality Assurance function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Requirements Technical Competencies Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures). Demonstrated knowledge of cGMP and GLP requirements and regulations. Knowledge of trouble shooting and problem solving skills; e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc. Demonstrated knowledge of handling of Deviations and different laboratory investigations. Experience 3+ years experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or QC or Microbiology or Manufacturing Operations within the biopharmaceutical/ pharmaceutical industry. Experience working on QA/QC incoming material inspection or warehouse operations would be advantage. Experience working with SAP would be an advantage. Knowledge Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Demonstrated knowledge of ICH, EU and FDA GMP regulation. Demonstrated knowledge of Good Laboratory Practices (GLP). Qualifications Preferable that the individual has qualification Degree in Biopharmaceutical/ Pharmaceutical Science or other related science discipline. Behavioural Competencies Essential to have: Proven decision-making capabilities. Demonstrated collaboration, negotiation, conflict resolution skills and inclusive approach with a teamwork mindset. Analytical, problem solving & root-cause analysis skills Able to challenge the status quo with a continuous improvement mindset. Excellent interpersonal, verbal, and written communication skills Self-starter and self-motivated; organized with good attention to details. Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities Results oriented, with the ability to manage multiple priorities in a short period of time. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations. Desirable: Business acumen/commercial awareness. Other Requirements There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs. Must be willing to travel when required. There will be a requirement for direct reports to work shift pattern once the project phase is complete As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: QC lab investigations deviations CAPAs Empower HPLC Trackwise Benefits: Bonus Laptop Life Assurance Paid Holidays Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: EHS Specialist The Environmental Health and Safety Specialist will provide technical support on Environmental, Safety programs and support the development of the EHS Management system to facilitate the various start-up activities to ensure compliance with EHS regulatory requirements, Licences and standards and promote continual improvement on effectiveness of EHS programs. Organization Description: WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. Your Responsibilities: Support the establishment of an EHS management system to ISO14001 & 45001 accreditation for site. Implement and drive an effective EHS risk assessment process across the site, ensuring appropriate control measures are in place. Manage compliance on all environmental licences and permits such as GHG, GMO and IED compliance and support regulatory inspections and audits and submission of Annual Environmental Report to EPA. Develop, promote, and drive the maintenance of a strong, pro-active EHS culture on the site. Coach and Lead where necessary on event investigations to ensure root cause is identified and appropriate corrective and preventive actions are identified and tracked to closure. Support the environmental license process and ensure compliance with statutory legislation and internal policies and procedures. Coordinate activities regarding procurement, supply, provision, and maintenance of safety equipment ensuring compliance to relevant standards. Develop PPE management process for selection, approval, and procurement. Co-ordinate and develop the site Emergency Response programme, permit to work programme, and associated high risk work activities. Ensure compliance with statutory legislation and internal policies and procedures. Support & Lead Regulator audits and inspections where necessary with EPA, H.S.A related to IED, GHG, GMO licences and permits or in areas in health & Safety such as Dangerous goods, Biosafety, reportable accident/dangerous occurrence on site. Liaise with external EHS Agencies e. Ensure compliance with all environmental licenses for the facility. Support compliance with waste management program and drive continuous improvements. Assess training needs analysis, support the development of the EHS training programme, and deliver associated training as required. Perform all duties in accordance with GMP requirements, SOPs, and controlled documents. Will be flexible to take on additional tasks and responsibilities at the discretion of the EHS Associate Director. Will act as a role model for the Operations-EHS function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile: The ideal candidate for this position will have the following: Qualifications Degree in Science, Engineering and/ or Environmental, health & Safety is required. Postgraduate in Health & Safety or Environmental as a minimum IOSH membership is desirable Knowledge/Experience Experience working in a Bio Safety Level 2 manufacturing environment is preferable. Experience working in a start-up facility is an advantage. Experience of EHS management systems including e.g. ISO14001 or ISO 45001 Experience in IED license requirements and environmental management is desirable. Strong knowledge of EHS management systems, legislation and IED/GHG and GMO requirement is preferable. Minimum of five years experience in an Environmental, Health, and Safety role in a manufacturing or process industry, including leading root cause investigations as part of a department or program initiative. Technical Competencies Strong communication skills including written and verbal skills. Be innovative, by creating new & better ways for the organisation to be successful. Have a strategic mindset, seeing ahead to future possibilities & translating them into breakthrough strategies. Have excellent time management & organisational skills with a proven ability to multi-task, prioritise responsibilities & meet deadlines. Attention to detail and sound scientific problem solving will be fundamental to this role. Behavioural Competencies Positive track record of establishing and maintaining effective relationships with internal, external clients and customers. Ability to work well with other technical staff in a collaborative, fast-paced goal-driven environment. Self-starter with ability to complete work independently as well as successfully lead others if needed. Ability to work well with other technical staff in a collaborative, fast-paced goal-driven environment. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission -Any drug can be made, and any disease can be treated- dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us ator contact us via. WuXi Biologics is an equal opportunities employer. Skills: Communication Time Management Organisation
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia and Israel. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Manufacturing Support Specialist The Manufacturing Support Specialist is a key member of the manufacturing team providing continuity across the 24/7 manufacturing shift teams. This role is responsible for providing day-based support to the Manufacturing teams to ensure that batch manufacture is running as intended. This role will focus on providing support to the shift teams to ensure that MFG reportable KPIs are consistently met. Main area for focus will be related to the following: GMP Documentation Right First Time Execution, review and close out Manufacturing Audit Readiness Training Compliance Continuous Improvement CAPA/Change control Safety OEE As Manufacturing Support Specialist, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report into the Manufacturing Associate Director. Your Responsibilities In this role, you will be responsible for: Providing Cross Shift support to manufacturing personnel to promote best practice across 24/7 MFG shift teams. This role will be POC for the shift teams and be responsible for coordinating, screening and progressing improvement ideas generated from the Manufacturing Shift teams. This will be a varied and evolving role within the Manufacturing team which may also include leading manufacturing investigations, support continuous improvements and implementing good work practices for the shift teams Manufacturing Support Where appropriate provide MFG input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations. Support the disposition process, manage and track document execution and review. Participate in cross-functional project teams as applicable. Identify process improvement projects and implementation and work with MT and MSAT to priorities projects/support demands from the Business Unit. Coordinate communications across the shift teams to ensure consistent communication. Point of Contact for co-ordination of the Management of Cleaning Verification and Equipment Release. Compliance and Right First Time Execution Ensure manufacturing owned investigations & change controls are raised and closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented. Support audit readiness Internal facility audits and documentation tracking. Data gathering and trending where required to support process investigations. Support and lead a culture of Right-First Time (RFT) through partnerships with manufacturing shift teams and provide leadership in the use of Opex principles to optimize technical and business processes. Participates in HAZOPs and reviews documentation as required. Supports and monitors safety systems, safety audits and monitors behaviours and performance on shift as required and supports safety communications as required. Supports the investigation of safety or environmental incidents on shift as required and records, reports and resolves/escalates unsafe conditions or near misses that are observed. Perform all duties in accordance with GMP requirements, SOPs and controlled documents Will be flexible to take on additional tasks and responsibilities at the discretion of their manager Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture Your Profile Education: Third level qualification in a Science or Engineering related subject Knowledge/Experience: Familiarity with Biologics manufacturing processes (Bioreactors, Chromatography, Ultra filtration, etc.,) is required. Experience of investigations and change controls preferred. Understanding of OEE Minimum of 3-4 years experience in large-scale Biopharmaceutical Industry.? Thorough knowledge of current Good Manufacturing Practices (cGMP). Personal/Behavioural skills Interpersonal / Teamwork Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional matrix organisation essential. Excellent focus and attention to detail. Flexibility and positivity about change in a dynamic working environment Communication Skills Excellent communication skills (including computer literacy) with the ability to develop, build, present and defend investigations/root cause analysis in both written and verbal form. Project management Excellent organizational skills essential. Self-driven, able to handle multiple activities simultaneously, prioritizing as appropriate. Business acumen/commercial awareness Experience in continuous improvement using Lean manufacturing tools preferred. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: Organsiational Skills BioProcessing Analytical Benefits: Parking Pension VHI
Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: As Senior QC Systems Specialist, you will be responsible for the successful management and execution of all the IS activities supporting Quality and Laboratory information systems and will also lead the implementation of new Quality and Laboratory information systems and management of the associated team of reportees. The ideal candidate will have strong LAN, Windows Server, VMware, Citrix, AD, Domain Controls, IAM and Security experience. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description As Senior QC Systems Specialist, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting to the QC Equipment and Systems Senior Manager. Your Responsibilities Act as the Senior Specialist for Information Systems supporting Quality and Laboratory information equipment. Ownership and administration of the IS aspects of Lab equipment including analytical equipment platform architecture, system ownership and lifecycle management. Ensure that all Lab IT systems and Benchtop Analytical Equipment meet 21 CFR 11 and EU Annex 11 compliance requirements. Lead and manage a team of QC System Specialists, where applicable. Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and QC analytical personnel. Lead and support system improvements, development of detailed specification and standard operating procedures. Ensure that all associated protocols/reports are completed, reviewed and approved within agreed timelines in order to secure reliable, consistent & compliant operation of all Lab Equipment\Instruments to meet the GMP and business requirements of the labs. Lead technical root cause analysis, incident investigations and troubleshooting issues related to the Quality and Laboratory information systems. Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Support new technology introductions by performing IS assessments and implementing IS system configuration changes. Participate in Computer Software Validations. Solving complex problems, project management, lifecycle management and operational excellence. Develop, manage and support GxP change control requests per established SOPs and processes. Support cyber security initiatives tracking and scheduling the deployment of OS Patches Day to day vendor management and contract negotiations with focus on Quality and/or Laboratory information systems suppliers. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Will be flexible to take on additional tasks and responsibilities at the discretion of the Associate Director of QC Operations. Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role. Work with the QC, QA, and CSV teams to support the enhancement and optimisation of IT systems to meet end user requirements. Requirements Technical Competencies Experience with LIMS and Empower is desirable. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable in relation to Lab IT requirements. Experience with regulatory/customer audits is desirable. Experience 3+ years experience supporting Quality and/or Laboratory information systems in the biotechnology or pharmaceutical industries or has worked in similar Laboratory environments and has gained expertise in the use of Laboratory information systems Experience with the following systems would be an advantage: Chromatography (Empower Waters), Lab Data Archival (Nugenesis Waters), Electronic Methods Execution/Electronic Lab Notebook (SmartLab Biovia) LIMS (Sample Manager - ThermoFisher), Environmental Monitoring (MODA), Experience of the following: Windows Server , Windows NT, 98, XP, Win 7, MS Active Directory, DNS, DHCP, DFS, MS Office , MS Office Communicator, MS Lync 2010/2013, MS SharePoint 2007/2010, LAN/WAN/VPN. Technical leadership skills with a strong ability to support continuous improvement initiatives. In addition to leadership capabilities, candidates must have a working knowledge of the GAMP software development lifecycle. Experience with facility start-up projects (brown field or green field) is desirable. Experience in Training of personnel. Previous experience in a Quality Control/GMP environment is required. Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required. Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable. Knowledge Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required. Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required. Strong working knowledge of 21 CFR 11 compliance requirements as they relate to Lab IT systems. Ability to master, with minimal support, new IS technologies and processes Strong knowledge of databases, reporting and analytic systems Ability to ensure compliance with practices, policies, procedures, legal requirements and site objectives and goals. Qualifications University degree in related science/IT/quality discipline or relevant vocational qualifications required. Behavioural Competencies Strong leadership competencies with demonstrated management skills. Excellent communication, interpersonal and presentation skills. Ability to think critically and demonstrate troubleshooting and problem-solving skills. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities. Collaborative and inclusive approach to work and your colleagues. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Engage cross functionally in conjunction with a site-based team. Autonomous and a self-starter who will use their initiative to drive actions forward. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations Shift work and business travel may be required for this position as directed by departmental management. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: LIMS Empower Nugenesis SmartLab Windows MS Active Directory Benefits: Bonus Life Assurance Paid Holidays Parking Pension VHI
