This is what you will do: This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will support the medical writing (MW) activities for one or more clinical programs. This position will function with moderate supervision. You will be responsible for: Supporting clinical project teams by authoring and managing the development and completion of high-quality clinical regulatory documents including, but not limited to, clinical study protocols and amendments, clinical study reports, Investigator's Brochures and updates, and clinical Common Technical Document components (eg, Module 2 summaries). Ensuring strategic organization, clarity, accuracy, format, and consistency of scientific content. Representing MW cross-functionally and with external vendors, negotiating timelines as necessary. Participating with other MW team members to develop and implement process and standards, and take responsibility for execution in cross-functional teams. Maintaining adherence to internal guidelines, styles, processes, standard operating procedures, and regulatory requirements in partnership with colleagues from statistical, clinical, regulatory, quality, and patient safety functions. Developing effective collaborations with other functional lines within Alexion, and keeping abreast of regulatory, industry, and medical writing knowledge and best practices. You will need to have: 3-5 years of regulatory writing experience; will consider fewer years of writing experience combined with other relevant experience. Demonstrated capability to understand and summarize complex clinical data, and write and manage clinical study documents (eg, clinical study protocols, clinical study reports, and Investigator's Brochures). Knowledge of global regulatory requirements and ICH/GCP guidelines. Excellent oral, written, and presentation skills; advanced user of MS Office suite. Results- and compliance-driven; sets standard of excellence for self and others. The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours. We would prefer for you to have: MS or PhD degree in a relevant scientific/clinical/regulatory field. Ability to establish excellent internal and external relationships, including alliance partners and vendors. Team player who thrives in a team-based environment. Well-developed sense of ethics, responsibility, and respect for others. Agile learner with ability to work both collaboratively and independently, seeking advice as required. High level of flexibility and ability to innovate and adapt. #J-18808-Ljbffr
This is what you will do: The Manager manages technical and logistical services in compliance with document and system standards within the document management system and supports Development, Regulatory and Safety and the broader R&D organization with LMS curricula maintenance. Contributes to the implementation and conduct maintenance activities of systems, platforms, and processes in the remit of the Development Quality team. Acts as a point of contact and support related to these systems. You will be responsible for: Assists and or leads delegated activities related to Process and Training Governance ECMS (Enterprise Content Management System) Documentation Enablement and System Support Supports governance and compliance of documents and training Delivers guidance and document management service related to the systems Conducts maintenance activities related to ECMS and agreed related applications Interacts and collaborates with the ECMS Functional Lead, as well as other key Stakeholders, related to ECMS Documentation to achieve a good understanding and working practices related to Document Management and the use of ECMS system Interacts and collaborates with the Business Process Owner (BPO) for Manage Procedural Documents to achieve a good working practice related to the use of ECMS system and procedural documents Provides metrics and creates reports in the ECMS Supports inspections Analyses the queries from the user community to identify improvement opportunities in reference materials & system functionality supporting all types of documents in ECMS and escalates findings. Support functions in maintaining LMS curricula for training assignments. Liaison with AZ R&D Learning Services and GLS for Alexion job roles Analyses the queries from the user community to identify improvement opportunities in reference materials & system functionality supporting the learning management system. You will need to have: Bachelor’s Degree in life sciences or similar scientific subject 8+ years of experience in pharmaceutical quality GxP Document and Learning Management systems knowledge Excellent analytical, written and oral communications skills Proven expertise in system administration and information management Strong collaborative, influencing and interpersonal skills – curious to understand business environment Ability to maintain and create professional networks with stakeholders High attention to detail and accuracy High ethical standards, trustworthy, operating with absolute discretion Excellent communication skills; fluent oral and written English Skilled at managing & using technology We would prefer for you to have: Good analytical, problem-solving and negotiation skills Experience in working in a global role Cultural Awareness and Positive attitude in managing change Project Management experience AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
Position Summary The position will manage and lead all aspects of ongoing Inspection Readiness for all of QC and QC readiness for scheduled internal and external audits. The position will manage and drive close-out of any commitments/actions from such audits. The position will work cross functionally within QC to support significant investigations and drive improvements. Responsibilities: Ensure compliance with Alexion procedures and values. Represent the QC department in internal and external audits. Lead the close out of actions/recommendations identified from both internal and external audits and any compliance gaps identified within QC through investigations, risk assessments, etc. Work cross functionally within QC to support significant investigations utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with other relevant departments and to support implementation of effective corrective and preventative actions. Represent QC and work across functions for ADMF Site Compliance projects such as Risk Register, Quality Bridges, and other projects as required. Drive QC inputs for QMR. Keep management updated on issues and escalate as appropriate. Proactively engage with key stakeholders across the business. Represent QC at internal and external meetings in the absence of the QC Director. Mentor and train QC staff as required. Knowledge, Skills and Abilities Ability to develop collaborative relationships with other functions. Excellent problem-solving and root cause analysis skills. Routinely takes an innovative approach in developing processes and procedures that are both efficient and compliant. Excellent knowledge of systems and ability to use data analytics tools is an advantage. Strong organizational skills. Planning/scheduling of own work and ability to delegate tasks where appropriate. Excellent written and oral communication skills. Qualifications and Key Competencies Degree in chemistry or biological science or equivalent combination of education and experience. Minimum 7-10 years of laboratory experience in a GMP laboratory/manufacturing environment within the Pharma/Biotech industry. Proven ability to work in a matrixed organization. Project management skills required. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
Principal Enterprise Architect, RDU Operations IT Alexion Pharmaceuticals, Inc. Dublin EUR 80,000 - 100,000 Introduction to the role and the project: AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. At AstraZeneca, we’re dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and spark your ambitious spirit. There’s no better place to make a difference to medicine, patients, and society. The Senior Enterprise Architect has overall accountability for the consistent implementation of architecture decisions across business and IT to support the AZ business and IS strategy, ensuring architectures are aligned with relevant AZ standards, blueprints, and roadmaps. The role will be responsible for partnering with key business and IT Leadership teams, integrating information from business strategies and portfolios to develop the overall strategic direction and integration of Alexion’s architecture portfolio. Accountabilities: Understand implications of architecture requirements to ‘As-Is’ architectures and define/update ‘To-Be’ architectures applying AZ architecture guiding principles. Support Alexion Global Operations strategic solution development efforts originating from portfolios. Participate in and/or lead IT initiatives, domain groups, and provide active mentorship for better planning and decision making. Accountable for the creation, stewardship, and management of the operation’s technical architecture, application landscape, and business capability roadmap. Minimum Requirements: Educated to degree level standard or equivalent (business technology or related degree). Experience of architecture strategy work, including business capability mapping, as-is and to-be application landscape documentation and analysis, and roadmap creation. 5 years experience producing application strategies/road maps for a global enterprise in pharma with experience in global operations. Experience defining and aligning architectural roadmaps and strategies to business strategy. Qualification(s) in, and experience of pragmatic adoption of, Enterprise Architecture frameworks – TOGAF, Zachman. Expertise in architecture options analysis, and ability to problem solve issues of a highly sophisticated and strategic nature. Experience with rationalization, consolidation, and integration across business domains using a formal framework. Experience of strategic justification phase work – product evaluation, business case formulation. Experience influencing key senior stakeholders in business and IT to adopt change or innovative solutions. Experience of leading and negotiating with third-party suppliers. Excellent communication, facilitation and relationship building skills at senior levels. Ability to interpret and communicate technical information into business language. Awareness of developments in the marketplace for manufacturing domain focus and potential impact to Alexion / Ops IT. Experience of developing innovative solutions, blueprints, and standards for solution design. Ability to travel to AstraZeneca’s global Operations sites. Externally recognized as a proven leader in an area of the EA practice. Experience of architecture leadership within the pharmaceutical industry. Experience of Architecture tooling such as lean IX. Demonstrate initiative, strong customer orientation, and cross-cultural working. Masters and/or Professional Certification. Shown ability to partner and work in a matrix organization. When we put unexpected teams in the same room, we unleash bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Why AstraZeneca? As Architects, we connect the dots across the business to improve the agility and functionality of our processes to accelerate AstraZeneca to the next level. There's so much potential to influence and inspire change; it's a big challenge if you're up for it. With the freedom to explore industry-leading innovative technologies, there are no limits to the impact you can make as you are empowered to change ways of working and behaviours across AstraZeneca. Ultimately it's the patient that benefits from the difference we make, and that's why we love it. Ready to make your mark? Apply now! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. #J-18808-Ljbffr
Business Area Alexion (AstraZeneca Rare Disease) is a high growth bio-pharmaceutical company with operations in over 40 countries worldwide. Our Global Finance Services (GFS) team in Dublin plays a critical role in delivering monthly and quarterly reporting, while also managing the statutory audit requirements for 38 entities globally. An opportunity has arisen for a 15 months fixed term contract for a Manager, Statutory Reporting . The Manager, Statutory Reporting will be part of the Statutory Reporting team within the AZ Global Finance Services (GFS) finance function. This is what you will do: Support the Associate Director, Statutory Reporting in ensuring the timely preparation and filing of annual financial statements for 31 entities across EMEA and APAC. Oversee the statutory reporting metrics and provide regular updates on key milestones to stakeholders. Complete request lists for external service providers (statutory and corporate taxation) and auditors. Review local GAAP Trial Balances and Financial Statements, ensuring compliance. Support tax provision calculations and transfer pricing reviews. Present Financial Statements to stakeholders and signing directors. Coordinate legal sign off and filings. Analyse availability of retained earnings for dividend distributions. Assist with group audit procedures as required. Address ad hoc queries e.g. on tax audits. Collaborate with other teams on liquidations. Identify process improvements to enhance efficiency, accuracy and effectiveness of the Statutory Reporting process. You will need to have: Qualified Accountant (ACCA, ACA, CIMA, CPA) Bachelor’s degree 3+ years PQE experience in a relevant environment Strong attention to detail, accuracy, and the ability to meet deadlines in a fast-paced environment. Excellent written and verbal communication skills. Proficiency in Microsoft Excel with strong numeracy and analytical skills. Ability to engage in problem-solving, critical thinking, and collaboration in an office-based environment. The duties of this role are generally conducted in an office environment. Employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: Experience using SAP, Anaplan, Qlik and Power BI a plus Demonstrated success in a deadline driven, multi-task environment. A “can-do” attitude with a proactive approach to challenges. Ability to work effectively in a high-growth, fast-paced, and multi-tasking environment. Ability to work independently and as part of a team. Demonstrated success in managing multiple priorities and meeting deadlines. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
This is what you will do: The Manager, Intercompany Accounting will be a key member of Alexion’s (AstraZeneca Rare Disease) Controllers team and is based in Dublin. This position is a Global Role that will be part of a wider team that supports intercompany accounting for the Rare Disease Business Unit. Alexion (AstraZeneca Rare Disease) is a high growth bio-pharmaceutical company with operations in over 40 countries worldwide. As Alexion (AstraZeneca Rare Disease) has grown in size and geography, the Controllers team has excelled as a high-performing team delivering on both monthly and quarterly IFRS results and managing the control environment. This role provides the opportunity to interact and learn from both Operations and Finance teams. The successful individual will need to be a self-starter, keen to learn, flexible and able to operate in a very dynamic environment. You will be responsible for: Handle day to day intercompany activity for the Group inclusive of Non-Trade activity Preparing monthly intercompany consolidated reporting summary Operate within the required SOX controls framework, completing assigned control procedures for the Intercompany area. Manage our Outsource provider and ensure timely completion of deliverables Handle our intercompany process into AstraZeneca Group Prepare commentary for semi annual RDU Consolidated results Manage month end process for a number of Legal Entities inclusive of Flux review, reconciliation review and quarterly sign off’s Manage R&D recharges for the Group Support the Legal entity forecasting process with responsibility for R&D and intercompany Support with group and local statutory audit requests in addition to tax requirements inclusive of US GAAP financials Participate in various finance related projects, as required. Support Legal entity accounting (step plans, new entities, mergers and liquidations) Support with Treasury activities relating to intercompany transactions (cash sweeps, netting process) You will need to have: Accounting Qualification (ACA/ACCA/CIMA etc.) Minimum 5 years’ industry/post qualification experience Strong numeracy and analytical skills with focus on attention to detail Strong verbal and written communication skills High level of Microsoft Office Excel proficiency We would prefer for you to have: Natural curiosity and ability to learn quickly Strong understanding of IFRS accounting principles Intercompany Accounting experience Multinational pharmaceutical experience If this sounds like a team you want to be a part of, we’d love to talk! #J-18808-Ljbffr
This is what you will do: This position is accountable for the timely delivery of high-quality clinical regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the medical writing (MW) activities across a disease area or set of clinical programs. This position will function with minimal supervision. You will be responsible for: Lead development and implementation of document strategy for clinical regulatory submission documents and other clinical documents including clinical study protocols, clinical study reports, Investigator's Brochures, and clinical Common Technical Document components (eg, Module 2 summaries). Contribute to the development of briefing packages, responses to health authority inquiries, and other IND/CTA or global regulatory submission documents. Support clinical project teams by authoring and managing high-quality MW deliverables in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Represent MW cross functionally, negotiating timelines as necessary. Support consistent messaging across all submission documents (nonclinical, clinical, and product labeling). Review to ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards. Direct and mentor MW team members (internal and external), ensuring quality and efficiency in the production of clinical regulatory documents. Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical, clinical, regulatory, quality, and drug safety colleagues. Develop effective collaborations with other functional lines within Alexion, and externally with regulatory, industry, professional, and academic organizations. You will need to have: Excellent oral, written, and presentation skills; advanced user of MS Office suite. Thorough knowledge of global regulatory requirements and ICH/GCP guidelines. Demonstrated aptitude for managing the work of external and/or internal medical writers, as well as training and fostering development of less experienced staff. Well-developed sense of ethics, responsibility, and respect for others. The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: PhD or MS degree in life sciences or advanced degree in a relevant scientific/clinical/regulatory field. Ability to establish excellent internal and external relationships, including alliance partners and vendors. Skilled at planning, budgeting, and project management, as well as problem solving, organization, and negotiation. Experience in rare and ultra-rare diseases. Results-driven and with high standards of excellence for self and others. High level of flexibility and ability to innovate and adapt to changing conditions. #J-18808-Ljbffr
At AstraZeneca, we are dedicated to delivering life-changing solutions to those living with rare and devastating diseases. We value diversity and recognize that nurturing our employees' unique perspectives and strengths results in innovative breakthroughs for our patients. Location : This position is available in a hybrid model, with flexibility to be based in Dublin, Athlone, or Cork . Responsibilities: Business Partnership and Development: Develop and maintain strong working relationships with multi-functional teams, including operations, finance, and IT Global Supply Chain Teams, focusing on Transport and Distribution operations. Anticipate industry trends and technological advancements, identifying opportunities for innovation and improvement in the supply chain technology landscape. Propose strategic technologies, tools & approaches, leveraging experience in Transport and distribution technology. Foster knowledge sharing and social networks to enable information flow and promote best practices. Drive end-to-end Delivery Management covering the full project initiation and life cycle (SDLC), including qualification for bid/financing, staffing, client management, and governance. Identify and implement technology solutions to enhance supply chain performance, such as automation, data analytics, and AI/ML Technologies. Maintain relationships with external technology vendors and partners to ensure optimal performance and service delivery. Leadership: Collaborate with Senior Business and IT leaders to build and gain consensus for a multi-year implementation road map for Global Supply Chain Processes/Systems, with a focus on Logistics Transport and Distribution. Drive core strategic objectives related to logistics, transport, and distribution technology. Lead integrated (both IT and Business) teams to deliver solid technology solutions in support of key client initiatives. Co-ordinate the preparation of customer proposals and statements of work, running high-level client expectations and relationships. Deliver progress reports to the functions Supply Chain & IT Leadership teams, maintaining company quality and quantity standards across the IT Organisation. Requirements: Education and Experience: Bachelor's degree in Information Technology, Supply Chain Management, or a related field; MBA or Master's degree preferred. 10+ years experience in IT Operations/Supply Chain management, with a proven track record of success. Strong understanding of supply chain processes, including IBP (Integrated Business Planning), logistics, and inventory management. Extensive knowledge of supply chain technology systems, including ERP: Enterprise Resource Planning (e.g., SAP ECC / 4HANA), WMS: Warehouse Management System, TMS: Transportation Management System, CRM: Customer Relationship Management, and ML & AI Adoption for system integration. Practical experience handling GxP documentation. Knowledgeable in establishing integrations with Third Party Logistics providers. Experience in traceability technology. Good practical knowledge of the GS1 body of Logistics and Transportation standards. Experience with EDI and PEPPOL. Experience with exception-based management, including monitoring systems, programmable pagers, anomaly detection, etc. Skills: Strong analytical skills and experience in data analysis and reporting. Excellent leadership and team management skills. Good communication and interpersonal skills, with the ability to communicate effectively with collaborators at all levels of the organization. Ability to lead multiple projects and initiatives simultaneously and deliver results. Strategic mentality and experience with supporting a manufacturing operations environment. Preferred Qualities: Demonstrated Leadership qualities to lead multi initiatives involving systems & data. Driven to process improvement and solution identification. Commercially focused, with high levels of passion and energy. Good communication, analytical, and decision-making skills. Ability to work on your own initiative, with flexibility for international travel where required. Service-oriented and adaptable to a multicultural environment, valuing diversity within a virtual distributed team environment. This revised job description outlines the key responsibilities and requirements of the Senior Manager – IT Business Partner – Logistics Transport and Distribution role, emphasizing the need for experience in transport and distribution technology and its integration within the supply chain management. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
This is what you will do: This position is accountable for the timely preparation of high-quality clinical regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the medical writing (MW) activities across a disease area or set of clinical programs. This position will function with limited supervision as required. You will be responsible for: Author and manage the completion of clinical documents including clinical study protocols and amendments, clinical study reports, Investigator's Brochures and updates, and clinical Common Technical Document components (eg, Module 2 summaries). Contribute to the development of briefing packages, responses to health authority inquiries, pediatric investigational plans, and other IND/CTA or global regulatory submission documents. Support clinical project teams by authoring and managing high-quality MW deliverables in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Represent MW cross-functionally, negotiating timelines as necessary. Support development and implementation of strategy for writing and completion of high-quality clinical documents. Participate with other MW team members to develop and implement process and standards and take responsibility for execution in cross-functional teams. Maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical, clinical, regulatory, quality, and drug safety colleagues. Develop effective collaborations with other functional lines within Alexion, and externally with regulatory, industry, professional, and academic organizations. Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards. Mentor less experienced MW team members (internal and external), ensuring quality and efficiency in the production of clinical regulatory documents. You will need to have: Clinical regulatory MW experience, including global clinical studies and regulatory submissions. Will consider less MW experience combined with other relevant pharmaceutical industry experience. Demonstrated capability to write clinical study documents (eg, clinical study protocols, clinical study reports, Investigator's Brochures, and Module 2 summaries). Excellent oral, written, and presentation skills; advanced user of MS Office suite. Thorough knowledge of global regulatory requirements and ICH/GCP guidelines. Skilled at project management, with emphasis on time management, organization, and negotiation. Results- and compliance-driven; sets standard of excellence for self and others. We would prefer for you to have: PhD or MS degree in life sciences or advanced degree in a relevant scientific/clinical/regulatory field. Experience with global clinical studies and regulatory submissions. Ability to establish excellent internal and external relationships, including alliance partners and vendors. Team player who thrives in a team-based environment. Well-developed sense of ethics, responsibility, and respect for others. Agile learner with ability to work both collaboratively and independently, seeking advice as required. High level of flexibility and ability to innovate and adapt to changing conditions. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
This is what you will do: Position Summary : Alexion, AstraZeneca Rare Disease’s Central Quality Systems and Compliance (CQSC) unit is looking for an Associate Director of Quality Systems to join our team. CQSC partners with internal stakeholders across Alexion Quality, Commercial, IT, Operations and Supply Chain to deliver an effective & compliant quality system for drugs and devices. In this role, the successful candidate will lead diverse quality systems initiatives with the objectives of evolving Alexion’s global quality management system and empowering our business partners to leverage quality as a strategic enabler. You will be responsible for: Lead implementation of value-added Quality Management System (QMS) improvements in collaboration with global stakeholders to achieve Alexion’s strategic Quality priorities. Sustain and improve QMS compliance in Change Control and other areas of assigned focus. Provide tactical and operational support to the Global Change Control Business Process Owner, including but not limited to, stakeholder management, process improvement execution, communication, technical writing and learning program development. Use deep process knowledge and experience to assist global business partners with the creation, review, approval, closure and monitoring of change controls. Identify, assess, communicate, manage, and mitigate quality system risks. Lead Change Control Review Boards (CCRBs) and drive CCRB improvement and standardization globally. Evaluate new or revised regulations for compliance gaps and support remediation efforts for gap closure. Represent CQSC function on business development and integration projects. Create and update procedural documentation and work instructions with accuracy and clarity. Support GMP and GDP audits and inspections. Liase with external consortia to keep abreast of industry trends and benchmarking. Creates and environment supportive of Alexion RDU’s Quality Culture and Values. You will need to have: 10 years’ + experience in Quality Systems within the pharmaceutical industry. Bachelor’s degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology) Able to plan, prioritize and manage workload and manage shifting priorities to ensure commitments are met. Knowledge of global GxP requirements for quality systems, drugs, and devices. Direct prior experience with planning, ownership, and quality oversight of change controls. Excellent written and verbal skills and strong interpersonal skills Experience managing global projects with team members in multiple locations The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: 3+ years’ experience with GDP compliant Commercial Operations, Supply Chain and/or Product Distribution activities within the pharmaceutical industry. Lean Green Belt or Black Belt certification preferred. ASQ Auditor certification or equivalent certification/experience. Knowledge of Veeva Vault Quality, Microsoft PowerBI and TrackWise. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
