MS&T Associate Director RK23012 Contract – 11 months Dublin Hybrid We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role supports the development of the site, providing leadership and Drug Substance technical support, in the Process Sciences Laboratory. Leads/participates in cross functional teams to deliver all project and investigational activities on schedule. The successful candidate will develop a talented team of Manufacturing Science & Technology Scientists in delivery of new products for commercial operations. Duties: Manage, coach, and mentor the MS&T drug substance team in performing advanced technical experiments. Inspire, reward and develop individuals, helping them to reach their potential. Technical Lead for MS&T Process Sciences and the site. Provide proactive, technical oversight of the biologics inline & pipeline products. Lead technical assessments for process investigations, risk assessments, evaluation of specifications and material qualification. Coach the team on development and execution of technical studies, continuous improvement of existing biologics processes and for new product launch. Complete experimental design, execution, data analysis and interpretation for improvement programs. Oversight of the product robustness trends observed in commercial operations and alignment with laboratory models, such as SIMCA for multivariate data analyses. Lead and/or support deployment and use of various digital tools at Biotech Dublin facility: Leverage these tools to deliver business value through predictive/proactive issue resolution, rapid investigation closure, improved yield/throughput. Assist in the regulatory authoring and review of technical documentation, technical report writing and global regulatory submissions. Support creation of the laboratory budget and review actual performance against forecast. Educational and Experience: Ideally a Master’s in Biological Sciences/ Chemical Engineering/ Biological Engineering/Chemistry. 8+ years directly related working knowledge in academia, pharmaceutical or biotechnology company – along with a working familiarity of current regulatory requirements and current Good Manufacturing Practices. The successful candidate will also have demonstrated the ability to deliver projects and programs, with a strong understanding of lean and laboratory operations. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. #J-18808-Ljbffr
Senior Associate Quality Control 12 Months We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Ideally the person will have general test methods product samples. Eg Ph, Appearance, Colour, Clarity, Protein Concentration, Moisture, etc., along with technical writing experience. This person needs to have experience planning and performing multiple, complex routine/non-routine methods & procedures, and should have conducted lab investigations within a biopharmaceutical, pharmaceutical or medical device industry. Duties: Plan and perform analyses with great efficiency and accuracy. Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. Report, evaluate, back-up/archive, trend and approve analytical data. Troubleshoot, solve problems and communicate with stakeholders. Initiate and/or implement changes in controlled documents. Participate in audits, initiatives and projects that may be departmental or organizational in scope. Review protocols and perform assay validation and equipment qualification/ verifications when required. Introduce new techniques to the lab, including method transfers, reports, validations and protocols. May contribute to regulatory filings. May conduct lab investigations as necessary. Evaluate lab practices for compliance on a continuous basis. May interact with outside resources. LIMS data coordination of commercial and import testing on site where applicable May represent the department/organization on various teams and may train others. Senior Associate Quality Control 12 Months We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Ideally the person will have general test methods product samples. Eg Ph, Appearance, Colour, Clarity, Protein Concentration, Moisture, etc., along with technical writing experience. This person needs to have experience planning and performing multiple, complex routine/non-routine methods & procedures, and should have conducted lab investigations within a biopharmaceutical, pharmaceutical or medical device industry. Duties: Plan and perform analyses with great efficiency and accuracy. Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. Report, evaluate, back-up/archive, trend and approve analytical data. Troubleshoot, solve problems and communicate with stakeholders. Initiate and/or implement changes in controlled documents. Participate in audits, initiatives and projects that may be departmental or organizational in scope. Review protocols and perform assay validation and equipment qualification/ verifications when required. Introduce new techniques to the lab, including method transfers, reports, validations and protocols. May contribute to regulatory filings. May conduct lab investigations as necessary. Evaluate lab practices for compliance on a continuous basis. Approve lab results. May interact with outside resources. LIMS data coordination of commercial and import testing on site where applicable May represent the department/organization on various teams and may train others. Education and Experience: Hold a Bachelor’s degree in a Science related field is required. 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry. Have strong technical writing skills (e.g. updating SOP) and investigation skills. Experience with analytical techniques such as Compendial testing would also be advantageous Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. If interested in this posting please feel free to contact Avishek Singh at Avishek.singh@lifescience.ie or 0872827991 for further information. #J-18808-Ljbffr
QA Specialist (REMOTE) RK4397 12 Months Dublin We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. In this role you will be part of the Global Supply Quality team supporting oversight and maintenance of contract manufacturers. Duties: Act as disposition manager ensuring that batch disposition activities are completed in line with company standards Manage and drive Quality records to closure including deviation records, investigation reports Initiate Quality records for supplier related changes. Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed Provide data to the networks to support Quality Management Processes) Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. Take part in operational and quality improvement initiatives, programs, and projects. Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs. QA Specialist (REMOTE) RK4397 12 Months Dublin We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. In this role you will be part of the Global Supply Quality team supporting oversight and maintenance of contract manufacturers. Duties: Act as disposition manager ensuring that batch disposition activities are completed in line with company standards Manage and drive Quality records to closure including deviation records, investigation reports Initiate Quality records for supplier related changes. Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed Provide data to the networks to support Quality Management Processes) Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. Take part in operational and quality improvement initiatives, programs, and projects. Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs. Education and experience 4+ years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Good working knowledge of SAP Experience in investigations, project management and trending and analysis Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing. Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). If interested in this posting, please feel free to contact Rachel Kent at Life Science Recruitment for further information. #J-18808-Ljbffr
Job Title : Senior Regulatory Affairs Location : Bishopstown, Cork Benefits: Competitive Salary, Bonus, Pension, Healthcare + Excellent opportunity to develop your experience and career in an exciting company. Company: My client have recently been acquired and have developed a breakthrough single-use medical device, that addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear. Overview: In this role you will ensure that the company’s products and services comply with all relevant regulations and standards. You will collaborate with cross-functional teams to facilitate the regulatory approval process, manage submissions, and maintain compliance with evolving regulatory requirements. This is an exciting opportunity to be at the forefront of innovation and make a significant contribution to the company's success. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Responsibilities: Develop and execute regulatory strategies for product registration, approval, and compliance. Manage day-to-day regulatory activities as well as handling multiple projects related regulatory compliance enhancements. Management of regulatory submissions, including the preparation, maintenance, review, and submission of regulatory documents and applications to health authorities. Support the team to obtain / retain country-specific regulatory registrations on a global basis. Manage the implementation of MDSAP within the organisation. Monitor and ensure compliance with national and international regulatory requirements and quality standards. Identify and assess potential regulatory risks and propose/implement effective mitigation strategies. Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes. Stay current with changing regulations, guidelines, and industry trends. Contribute to maintaining the highest level of quality within the organisation by assessing overall risk profiles and then creating programs / tools to mitigate potential risk Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to: Working collaboratively with KARL STORZ Logging customer complaints and adverse events Coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required Regulatory trending and reporting activities as required Manage CE mark submissions, significant change notifications and Notified Body interactions. Support the team with the preparation of international regulatory filing, including 510(k) submissions and subsequent FDA correspondence. Review / approve public-facing materials for regulatory compliance Carry out other regulatory-related duties as required. Job Title : Senior Regulatory Affairs Location : Bishopstown, Cork Benefits: Competitive Salary, Bonus, Pension, Healthcare + Excellent opportunity to develop your experience and career in an exciting company. Company: My client have recently been acquired and have developed a breakthrough single-use medical device, that addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear. Overview: In this role you will ensure that the company’s products and services comply with all relevant regulations and standards. You will collaborate with cross-functional teams to facilitate the regulatory approval process, manage submissions, and maintain compliance with evolving regulatory requirements. This is an exciting opportunity to be at the forefront of innovation and make a significant contribution to the company's success. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Responsibilities: Develop and execute regulatory strategies for product registration, approval, and compliance. Manage day-to-day regulatory activities as well as handling multiple projects related regulatory compliance enhancements. Management of regulatory submissions, including the preparation, maintenance, review, and submission of regulatory documents and applications to health authorities. Support the team to obtain / retain country-specific regulatory registrations on a global basis. Manage the implementation of MDSAP within the organisation. Monitor and ensure compliance with national and international regulatory requirements and quality standards. Identify and assess potential regulatory risks and propose/implement effective mitigation strategies. Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes. Stay current with changing regulations, guidelines, and industry trends. Contribute to maintaining the highest level of quality within the organisation by assessing overall risk profiles and then creating programs / tools to mitigate potential risk Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to: Working collaboratively with KARL STORZ Logging customer complaints and adverse events Coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required Regulatory trending and reporting activities as required Manage CE mark submissions, significant change notifications and Notified Body interactions. Support the team with the preparation of international regulatory filing, including 510(k) submissions and subsequent FDA correspondence. Review / approve public-facing materials for regulatory compliance Carry out other regulatory-related duties as required. Education Bachelor’s degree in Engineering or Science with a minimum of 6 years of regulatory experience in the medical device industry. Regulatory certifications in EU MDR and US FDA desirable. Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, 21 CRF 820 and supporting standards. Proven track record with the ability to successfully manage projects to deadlines. Experience working directly with regulatory agencies. Strong ability to manage critical projects as part of an interdisciplinary team. Does this sound like your next career move? To apply, forward your application to the link provided or contact me on 087 0608656 OR colin.clare@lifescience.ie #J-18808-Ljbffr
Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Life Science Recruitment Senior Recruitment Consultant at Life Science Recruitment - Supply Chain ~ Quality ~ Manufacturing We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. The role will be responsible for providing Metrics reporting and analysis to provide visibility into business processes and implement digital analytics solutions to drive value within the Quality Control team. Key Responsibilities: Analysing and reporting of QC Business process key performance Indicators Generation of reports required for method tracking and trending and across multiple testing platforms in line with current GMP procedures Fostering a culture of data analytics and data visualisation through sharing of best practices and training of QC staff. Support the definition and advancement of a self-service reporting model. Understanding business needs and developing practical data-driven solutions to meet those needs. Identify, manage and implement data analytics solutions for continuous improvement projects related to laboratory operations. Support to cross functional analytics projects. Building relationships with key business stakeholders, defining user requirements. Championing adaptation of digital technology solutions within a QC lab environment Development activities in SharePoint and Microsoft teams. Liaise with IT teams for troubleshooting activities. Write SQL queries and provide support for routine data pull request tickets. Performing ad hoc data mining and analysis. Exploring and evaluating new digital tools and techniques to advance operational capabilities. Provide support as required for design, build and validation activities related to LIMS downstream reporting application business reports. Education and Experience: Hold a third level qualification in science discipline 2-5 years’ experience within a Quality control laboratory Familiarity with common laboratory operations systems, such as LIMS and LMES Proficiency in programming languages, with emphasis on SQL, Python, and/or R is an advantage If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Manufacturing Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Life Science Recruitment by 2x Sign in to set job alerts for “Senior Quality Control Analyst” roles. Dublin 4, County Dublin, Ireland 2 weeks ago Dublin, County Dublin, Ireland 19 hours ago Dublin, County Dublin, Ireland 4 days ago Process Development Laboratory Chemist FTC (30.11.2027) Dublin, County Dublin, Ireland 3 weeks ago Process Development Chemist_Maternity Cover Dublin, County Dublin, Ireland 6 days ago Process Development Laboratory Chemist FTC (30.11.2027) Dublin, County Dublin, Ireland 1 month ago Process Development Chemist_Maternity Cover Dublin, County Dublin, Ireland 4 weeks ago Dublin, County Dublin, Ireland €22.00-€28.00 3 weeks ago Dublin, County Dublin, Ireland 6 days ago Dublin, County Dublin, Ireland 4 days ago Dublin, County Dublin, Ireland 2 weeks ago Dublin, County Dublin, Ireland 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Job title: R&D Sustaining Manager Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare, and opportunity to grow your career with a hugely exciting Medical Device organisation. Company: My client is a Medical Device company recently acquired by a multinational, a global leader in neurovascular care, with a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke. The company invests in its people and prides itself on providing a positive work environment that respects diversity, supports wellbeing, and embraces innovation. About the role: The R&D Sustaining Manager will be responsible for managing design changes and sustaining activities, providing technical leadership and judgment to a team of engineers throughout the lifecycle of a portfolio of devices to treat ischemic and hemorrhagic stroke. Some responsibilities include: Responsible for R&D (LCM) activities for the portfolio of products. Leading the R&D team, including team structure, development, and performance management. Identifying critical project tasks, defining strategy, and setting team priorities. Developing detailed project goals, plans, and budgets. Reporting progress across the organization. Organizing and prioritizing activities, including escalations, in collaboration with key functions and aligning on deliverables and timing. Managing interfaces between functions such as Supply Chain, Quality, and Regulatory to support product lifecycle management, including working with: o Quality and Design Assurance in risk assessment of design and process changes, re-certification, and vendor audits. o Supply Chain and Manufacturing in developing cost improvement programs with external partners. o Supporting customer visits with presentations on product development history. Supporting customer complaint investigations and representing R&D in review meetings, including complaint trending and alert/action levels. Contributing to the cultural development of the R&D department by identifying and implementing continuous improvement initiatives. Requirements: Honours degree in Engineering or Science (desired) with strong technical skills. Significant experience in R&D or product sustaining roles within the medical device industry. Leadership experience in managing teams. Ability to work within design control systems and processes. What awaits you: This is an opportunity to join a groundbreaking biomedical organization, part of a company known for excellent professional development and continuous improvement. - Be part of a global market leader. - Work in a dynamic and inspiring environment. - Engage in challenging projects and assignments. - Opportunities for personal and professional growth and education. - Excellent benefits. Interested? To apply or for more information, please send your application via the provided link or contact Thomas Gallagher at 087 0612325 or thomas.gallagher@lifescience.ie. #J-18808-Ljbffr
Did you know that your Internet Explorer is out of date? To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser. Name: Surname: Email: Phone: Cv: Salary Expectations: Education: Experience: Current Location: Notice Period: Write here your cover note: If you would like us to create a jobseeker account for you, giving you access to account management, job alerts and one-click applications, then please tick this box If you are having difficulty you can always email your cv to applications@lifescience.ie Role: Regulatory Associate Location: Bishopstown, Cork Benefits: Top salary, Hybrid working, bonus, pension and healthcare Company: My client are an innovative Cork-based med‑tech spin‑out disrupting paediatric ENT care with a streamlined, in‑office ear‑tube insertion device. They've scaled from Irish clinical success to U.S. regulatory approval and global roll‑out under a German multinational company. With a strong IP portfolio, seasoned leadership, and growing market presence, they’re well-positioned to change the standard of care in paediatric ear surgery. Role: You will be responsible for regulatory submissions worldwide, annual reporting to the notified body and competent authorities, and maintaining compliance to standards and regulations. You must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Excellent organisational skills, ability to balance immediate vs. long term priorities and strong multi-tasking skills are a necessity. An ability to work in a flexible and small entrepreneurial environment is essential and there is an excellent package available for the right candidate Responsibilities: Support day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements. Assist in the implementation of MDSAP within the organisation. Support the team to obtain / retain country-specific regulatory registrations on a global basis. Work with the Commercial Team / Distributors, to ensure country specific registration activities are understood and appropriately addressed. Work closely with interdisciplinary team members to ensure the effectiveness of the QMS to regulations. Work closely with QA for internal and external audits, including notified body audits as required. Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions. Work with the organisation’s suppliers to ensure the products’ process validations and risk management files are to the standard of regulatory submissions. Provide strategic regulatory insight to team members regarding product development plans Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to: working collaboratively with (Parent company) logging customer complaints and adverse events coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required regulatory trending and reporting activities as required Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance. Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs Keep abreast of changes in domestic and international regulations and guidelines and advise key staff of compliance/non-compliance with current international regulations, policies and EC directives. Support the team with CE mark submissions, significant change notifications and Notified Body interactions. Support the team with the preparation of international regulatory filings, including 510(k) submissions and subsequent FDA correspondence. Carry out other regulatory related duties as required. Role: Regulatory Associate Location: Bishopstown, Cork Benefits: Top salary, Hybrid working, bonus, pension and healthcare Company: My client are an innovative Cork-based med‑tech spin‑out disrupting paediatric ENT care with a streamlined, in‑office ear‑tube insertion device. They've scaled from Irish clinical success to U.S. regulatory approval and global roll‑out under a German multinational company. With a strong IP portfolio, seasoned leadership, and growing market presence, they’re well-positioned to change the standard of care in paediatric ear surgery. Role: You will be responsible for regulatory submissions worldwide, annual reporting to the notified body and competent authorities, and maintaining compliance to standards and regulations. You must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Excellent organisational skills, ability to balance immediate vs. long term priorities and strong multi-tasking skills are a necessity. An ability to work in a flexible and small entrepreneurial environment is essential and there is an excellent package available for the right candidate Responsibilities: Support day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements. Assist in the implementation of MDSAP within the organisation. Support the team to obtain / retain country-specific regulatory registrations on a global basis. Work with the Commercial Team / Distributors, to ensure country specific registration activities are understood and appropriately addressed. Work closely with interdisciplinary team members to ensure the effectiveness of the QMS to regulations. Work closely with QA for internal and external audits, including notified body audits as required. Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions. Work with the organisation’s suppliers to ensure the products’ process validations and risk management files are to the standard of regulatory submissions. Provide strategic regulatory insight to team members regarding product development plans Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to: working collaboratively with (Parent company) logging customer complaints and adverse events coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required regulatory trending and reporting activities as required Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance. Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs Keep abreast of changes in domestic and international regulations and guidelines and advise key staff of compliance/non-compliance with current international regulations, policies and EC directives. Support the team with CE mark submissions, significant change notifications and Notified Body interactions. Support the team with the preparation of international regulatory filings, including 510(k) submissions and subsequent FDA correspondence. Carry out other regulatory related duties as required. Required Education & Experience: Bachelor’s degree in Engineering or Science with a minimum of 3 years of regulatory experience in the medical device industry. Regulatory certifications in EU MDR and US FDA desirable. Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CRF 820 and supporting standards. Proven track record with the ability to successfully manage projects to deadlines Experience working directly with regulatory agencies Strong ability to manage critical projects as part of an interdisciplinary team Excellent problem solving and communication skills Must be self-motivated, highly organised and detail-oriented Excellent oral and written communication skills Must be able to work as part of a cross functional team Thrives to work in a fast-paced / entrepreneurial environment To apply for more info call me on 087 060 8656 or email colin.clare@lifescience.ie #J-18808-Ljbffr
Regional Operations Manager (South of Ireland) Regional Operations Manager (South of Ireland) Our client is looking for a Regional Operations Manager for the South of Ireland. The successful person shall be responsible for the overall coordination, operational management and business development of their Services team on our clients various customer sites throughout the Southern Region of Ireland. This includes managing the site services health & safety, training & compliance, and the overall line management of their on-site teams of Material Handlers, Labs associates and Site Managers coordinating their day-to-day tasks. You will also ensure a qualitative performance management processes by setting and continually review KPI metrics and ensuring adherence to their customers’ respective SLA’s and service development on their customer sites. The vision and purpose of the role is to deliver a high quality and efficient service to our clients customers. Working hours: Monday-Friday core hours (with flexibility as per business need) Working Location: Field based with regular site visits This is a full-time permanent contract as a member of their Ireland Lab and production services leadership team, a competitive salary package including company car, bonus and other advantages. You will be able to work home based but must be prepared to do weekly customer visits. In addition, you will have the opportunity to grow and develop in your role. Role/Responsibilities: How you will thrive and create an impact Manage, mentor, and motivate your teams to successfully perform their job duties and to meet/exceed goals and regional objectives Provide overall management to all sites under your jurisdiction, ensuring regular site visits to provide hands-on operational support Manage any HR related activity such as resource planning, sickness and absence (and arranging cover for these instances), appraisals, recruitment, and ensuring that all training and compliance is up to date across all sites Coordinate any issues as they arise, taking the appropriate corrective actions to ensure business continuity Continue to promote our on-site services to our customers and support the Sales team at enquiry stage, or with the bids and tender process at contract renewal stage Become the main point of liaison between our client & each customer, managing each individual customer on their own merit and aiming to increase profitability and efficiency Develop and maintain site SOP’s, Risk Assessments, Site Audit Schedules etc Manage budgeting activity, and also take responsibility for BOM reviews with customers, reviewing consumption and inventory metrics, and monitoring the prevalence of slow moving or provisional stock Regional Operations Manager (South of Ireland) Our client is looking for a Regional Operations Manager for the South of Ireland. The successful person shall be responsible for the overall coordination, operational management and business development of their Services team on our clients various customer sites throughout the Southern Region of Ireland. This includes managing the site services health & safety, training & compliance, and the overall line management of their on-site teams of Material Handlers, Labs associates and Site Managers coordinating their day-to-day tasks. You will also ensure a qualitative performance management processes by setting and continually review KPI metrics and ensuring adherence to their customers’ respective SLA’s and service development on their customer sites. The vision and purpose of the role is to deliver a high quality and efficient service to our clients customers. Working hours: Monday-Friday core hours (with flexibility as per business need) Working Location: Field based with regular site visits This is a full-time permanent contract as a member of their Ireland Lab and production services leadership team, a competitive salary package including company car, bonus and other advantages. You will be able to work home based but must be prepared to do weekly customer visits. In addition, you will have the opportunity to grow and develop in your role. Role/Responsibilities: How you will thrive and create an impact Manage, mentor, and motivate your teams to successfully perform their job duties and to meet/exceed goals and regional objectives Provide overall management to all sites under your jurisdiction, ensuring regular site visits to provide hands-on operational support Manage any HR related activity such as resource planning, sickness and absence (and arranging cover for these instances), appraisals, recruitment, and ensuring that all training and compliance is up to date across all sites Coordinate any issues as they arise, taking the appropriate corrective actions to ensure business continuity Continue to promote our on-site services to our customers and support the Sales team at enquiry stage, or with the bids and tender process at contract renewal stage Become the main point of liaison between our client & each customer, managing each individual customer on their own merit and aiming to increase profitability and efficiency Develop and maintain site SOP’s, Risk Assessments, Site Audit Schedules etc Manage budgeting activity, and also take responsibility for BOM reviews with customers, reviewing consumption and inventory metrics, and monitoring the prevalence of slow moving or provisional stock Education/Experience: Previous solid experience in managing teams in an operational environment (warehouse or inventory, business development, or customer service are ideal). People with a strong Retail background will also be considered. Preferably, experience working in a, scientific warehouse/materials handling operation or a scientific educational background or with a service provider providing third party services IT Savy: Excellent IT skills, proficiency with Microsoft Excel and PowerPoint is highly desirable Analytical skills: Proficient in data capture, analysis, and reporting utilising various IT software systems Strong Communication skills for internal and external stakeholders management at varying levels of seniority, regularly, both in person and virtually. Previous experience completing SOP’s, SOW’s, SLA, and risk assessments is desirable Leaving cert & strong people management experience OR 3 rd level qualification with operations experience Full, clean drivers licence For further details please contact: Karen Shiel on 087 745 2487 or send CV to karen.shiel@lifescience.ie #J-18808-Ljbffr
Direct message the job poster from Life Science Recruitment Our client a global pharmaceutical services company specialising in providing access to medicines, clinical trial services, and lifecycle management are currently recruiting for a Quality Specialist to join their team. This is an urgent role so ideally you will be available to start immediately. Experience with Good Distribution Practice (GDP) is essential. Responsibilities: Ensure compliance with GMP, GDP, SOPs, and company policies Manage quality documentation (procedures, reports, logbooks) Support QA training, audits, inspections, and supplier/customer approvals Review and manage CAPA, deviations, change controls, and complaints Gather and analyse QA data for reporting and compliance Assist in QA projects and respond to QA queries Work safely, follow procedures, report hazards, and use equipment correctly Support the Quality Management System and company strategy Maintain confidentiality, professionalism, and continuous improvement Requirements: Bachelor’s degree in a relevant field QA/Technical experience in pharma Knowledge of EU/UK pharma regulations, GMP, GDP, ICH guidelines Strong communication, attention to detail, and multitasking skills Seniority level Seniority level Associate Employment type Employment type Contract Job function Job function Distribution Industries Warehousing and Storage and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Life Science Recruitment by 2x Sign in to set job alerts for “Quality Specialist” roles. Sr Quality Specialist, Manufacturing Quality Compliance (Home Based / Remote) Dublin, County Dublin, Ireland 2 weeks ago Dunboyne, County Meath, Ireland 6 days ago Dublin, County Dublin, Ireland 5 months ago Clondalkin, South Dublin, Ireland 6 days ago Dublin, County Dublin, Ireland 1 week ago Dublin, County Dublin, Ireland 1 week ago Dublin, County Dublin, Ireland 1 week ago Dublin, County Dublin, Ireland 1 month ago Dunboyne, County Meath, Ireland 1 week ago Senior Quality Assurance Specialist (Drug Substance) (Remote/Home Based) Dublin, County Dublin, Ireland 1 week ago Dublin, County Dublin, Ireland 3 months ago Quality Assurance Specialist - Manufacturing Dublin, County Dublin, Ireland 4 hours ago Senior Quality Assurance QA Specialist - 12 Month Contract Dublin, County Dublin, Ireland 1 month ago Dublin, County Dublin, Ireland 1 week ago Dublin, County Dublin, Ireland 1 week ago Dublin, County Dublin, Ireland €22.00-€28.00 3 weeks ago Dunboyne, County Meath, Ireland 2 days ago Dublin, County Dublin, Ireland 1 week ago Dunboyne, County Meath, Ireland 6 days ago Dublin, County Dublin, Ireland 2 weeks ago Dublin, County Dublin, Ireland 1 week ago Dublin, County Dublin, Ireland 2 weeks ago Dublin, County Dublin, Ireland 5 hours ago Dublin, County Dublin, Ireland 1 week ago Dublin, County Dublin, Ireland 3 days ago Stamullen, County Meath, Ireland 1 week ago Stamullen, County Meath, Ireland 2 weeks ago Dublin, County Dublin, Ireland 1 week ago Senior Quality Specialist -FTC (Maternity Cover - 31.07.2026) Dublin, County Dublin, Ireland 2 days ago Dublin, County Dublin, Ireland 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System Role/Responsibilities Manage the regulatory and vigilance process. Prepare regulatory submissions for required markets coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion. Maintain technical files for all cleared products. Support the Senior Quality & Regulatory Manager in managing any required product certification testing. Support the Senior Quality & Regulatory Manager in managing the Risk Management process for all existing and new products. Complaints handling for medical reporting and filing to the appropriate competent authorities. Keep up to date with changing regulatory and compliance requirements e.g., REACH ROHS2 etc. Maintain environmental registrations for all markets. Support labelling and packaging updates and creations from a regulatory and clinical claims perspective. Complete internal audits as required and lead CE technical file audits for the company. Support the Quality team in maintaining the QMS Expert Knowledge of regulatory processes for EU, UK and FDA product clearance. Working experience of regulatory processes for ROW markets. Working experience of a certified Quality Management System. Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System Role/Responsibilities Manage the regulatory and vigilance process. Prepare regulatory submissions for required markets coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion. Maintain technical files for all cleared products. Support the Senior Quality & Regulatory Manager in managing any required product certification testing. Support the Senior Quality & Regulatory Manager in managing the Risk Management process for all existing and new products. Complaints handling for medical reporting and filing to the appropriate competent authorities. Keep up to date with changing regulatory and compliance requirements e.g., REACH ROHS2 etc. Maintain environmental registrations for all markets. Support labelling and packaging updates and creations from a regulatory and clinical claims perspective. Complete internal audits as required and lead CE technical file audits for the company. Support the Quality team in maintaining the QMS Expert Knowledge of regulatory processes for EU, UK and FDA product clearance. Working experience of regulatory processes for ROW markets. Working experience of a certified Quality Management System. Skills/Experience: You will have a third level degree and a significant amount of experience in medical devices. A post-graduate qualification in Quality Assurance along with experience of active medical devices would be an advantage. Significant regulatory affairs experience including experience of international regulatory processes. In depth knowledge of product certification testing requirements for active Medical Devices. In depth knowledge of maintaining a certified Quality Management System. Knowledge and application of Quality tools and Methodologies including lean six sigma, TQM etc. Experience of EN/MDD/MDR, ISO13485 and FDA requirements. Trained QMS Internal Auditor. Strong attention to detail. Excellent Verbal and written communication skills. Results orientated and a self-starter with the ability to work on own initiative. Knowledge of and commitment to continuous improvement and problem solving. Promote best practice and knowledge of the QSR and ISO/MDD standards. Advanced Microsoft Office and reporting tool skills. Strong project management skills. For further information please contact James Cassidy james.cassidy@lifescience.ie or call in confidence james.cassidy@lifescience.ie #J-18808-Ljbffr
