Senior Manager, Qualified Person

Pfizer, S.A. de C.V; Stone Cross; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A global pharmaceutical company is seeking a Qualified Person in Stone Cross, UK. The role involves evaluating investigational products, ensuring GMP compliance, and providing leadership within the Pharmaceutical Sciences Operations Quality team. Candidates should have strong experience in the pharma industry and be eligible for QP nomination. The position allows for hybrid work, with benefits promoting health, financial security, and time off for family care.

Benefits

Health and disability insurance

Retirement plan contributions

Parental leave policy

On-site health and fitness centers

Qualifications

• Eligible for nomination as a Qualified Person on a UK manufacturer’s authorization.
• Strong experience working in the pharma industry.
• Proven experience working in teams/partnerships, meeting tight deadlines, and ensuring GMP compliance.

Responsibilities

• Evaluate and review investigational products as a Qualified Person.
• Certification of finished IMPs and confirmation of partially manufactured IMPs.
• Maintain knowledge of relevant pharmaceutical legislation and GMP guidelines.
• Lead deviations and investigations, including root cause analysis.

Skills

Pharma industry experience

Teamwork and partnership

GMP compliance

Education

Qualified Person nomination eligibility

Job description

What You Will Achieve

As a member of Pfizer’s 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.

How You Will Achieve It

• 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 present at external industry meetings to influence the external environment.
• Provide clear, direct and timely verbal and written communication to internal and external stakeholders.

Here Is What You Need (Minimum Requirements)

• Eligible for nomination as a Qualified Person on a UK manufacturer’s authorization in accordance with the requirements of Schedule 7 of The Human Medicines Regulations 2012.
• Strong experience working in the pharma industry.
• Proven experience working in teams/partnerships, meeting tight deadlines, and ensuring GMP compliance.

Bonus Points If You Have (Preferred Requirements)

• Experience in the manufacture, release and supply of investigational medicinal products.
• Experience acting as Qualified Person in UK or EU.

Work Location Assignment

Hybrid (some office presence required).

Benefits at Pfizer

• Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced‑cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counselling and more.
• Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
• Providing Benefits and Time off for the Moments that Matter to ensure colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, holiday time and sick time are just the beginning, with a 12‑week parental leave policy for both parents of a newborn, 10 days of caregiver leave, bereavement leave and additional country‑specific programs.
• And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on‑site health and/or fitness centres, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.