Qualified Person (12 months Fixed Term)

This is what you will do:

• Responsible for delivery of quality assurance activities at Alexion’s Irish locations to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. This responsibility requires the delivery of QA and compliance support for the Irish site(s).
• The Senior Manager QA executes the site QA activities at Alexion in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, Site Services, Engineering and Planning to optimize patient supply. 
• This role is responsible for the quality oversight of new product introductions onto the Athlone site from initial manufacturing through to clinical and commercial supply and on-site quality systems management including deviations, change controls, supplier management, complaints, recall management & QRM.

You will be responsible for:

• Site QA responsibility to provide oversight and technical expertise for all QA and compliance topics/issues relating to Alexion manufacturing and product supply. Ensures the timely QP release of commercial and clinical product in accordance with agreed timelines for Drug Substance and Drug Product.
• Works closely and communicates regularly cross site(s) with finished product release QPs
• Acts as quality point person, providing feedback on quality systems to the Global Operations Quality group
• Provides quality oversight and ensures documents are approved to schedule to support technology (external and internal) transfers and new product introductions.
• Retain, lead, coach and develop QA Specialists. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
• Act as designee for the Department Manager in their absence.
• Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
• Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.
• Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement (including cold chain) for both clinical and commercial products.
• Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
• Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
• Actively contributes to continuous improvement activities.

You will need to have:

• A minimum of 5-8 years relevant experience within the pharma industry or a related field.
• A minimum of 3 years supervisory experience
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required. 
• Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing.
• Third level qualification e.g. B.Sc . in science/pharmacy with a minimum of 10 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
• QP Qualified is essential

We would prefer for you to have:

• Excellent accuracy and attention to detail
• Good knowledge of relevant computer packages e.g. Trackwise or similar, SAP
• Strong background in new product introduction and validation/revalidation is preferred.
• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
• High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
• The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a responsible and professional manner.
• Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.

Date Posted

30-Jul-2025

Closing Date

29-Aug-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.