Senior Manager, Qualified Person

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk‑based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

As a member of Pfizer’s dedicated and highly effective Pharmaceutical Sciences Operations Quality (PSOQ) team, you will evaluate and review Pfizer’s investigational products by acting as a Qualified Person (QP) in accordance with The Human Medicines Regulations 2012 (SI 2012/1916) and The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) as amended.

As a QP within PSOQ, the primary job function will be the QP certification and release of Investigational Medicinal Products (IMPs) for use in clinical trials in accordance with UK legislation. Duties are expected to include the following:

• QP certification of finished IMPs (release for clinical use in a specific study and country) in accordance with The Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended).
• QP confirmation of partially manufactured IMPs (release for further processing) in accordance with the principles and guidelines of good manufacturing practice (GMP).
• Maintain detailed knowledge of relevant pharmaceutical legislation and GMP guidelines and their application in R&D and commercial environments. Use this knowledge to educate Pharmaceutical Sciences colleagues and to act as a consultant in the development of the pharmaceutical quality system.
• Maintain knowledge of the relevant manufacturing processes, supply chains and quality control tests for Pfizer IMPs considering technical and scientific progress and development of the pharmaceutical quality system.
• Provide consultation and technical support to PSOQ teams to help ensure the effective delivery of a risk‑based pharmaceutical quality system meeting regulatory requirements, GMP expectations and company standards.
• Lead and participate in deviations and investigations including root cause analysis. Escalate and/or cascade technical/quality issues to management and partner lines. Support related regulatory authority interactions as required.
• Collaborate with the other global PSOQ teams to provide effective support for the partner lines across the Pharmaceutical Sciences network. Provide subject matter expertise representing QPs at cross‑functional forums and/or projects as endorsed by PSOQ leadership.
• Provide leadership, guidance and advice to PSOQ teams and associated business colleagues with respect to QP release of clinical products.
• Support the planning and scheduling of QP resource to ensure maintenance of operating capacity.
• Support outsourcing, in‑licensing and collaboration activities as required. Approve related Quality, Technical and/or QP-to‑QP agreements.
• Participate in GMP audits/ QP visits of manufacturing facilities and work to resolve audit observations as required.
• Approve QP Declarations of EU/UK GMP compliance for third country manufacturing sites in support of clinical trial applications.
• Lead and/or act as a subject matter expert in internal audits and regulatory authority inspections.
• Support management of the Sandwich manufacturer’s authorization.
• May participate in cross‑pharma technical bodies and presenting at external industry meetings to…