Senior Manager Qualified Person

Pfizer, S.A. de C.V; United Kingdom; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a Qualified Person to join their Pharmaceutical Sciences Operations Quality team. The role focuses on the certification and release of Investigational Medicinal Products for clinical trials according to UK legislation. Candidates should have strong experience in the pharmaceutical sector and be able to work in teams under tight deadlines. The position is hybrid, balancing office presence with flexible work arrangements, ensuring a collaborative and supportive environment.

Benefits

Competitive compensation

Health and wellness support

Retirement plan contributions

Paid parental leave

Qualifications

• Eligible for nomination as a Qualified Person on a UK manufacturer’s authorization per regulations.
• Strong experience in the pharmaceutical industry.
• Proven track record of working in teams, meeting tight deadlines, ensuring GMP compliance.

Responsibilities

• Evaluate and review investigational products as a Qualified Person.
• Certify and release Investigational Medicinal Products for clinical trials.
• Provide consultation and technical support to ensure effective delivery of a risk-based quality system.
• Lead deviations and investigations including root cause analysis.

Skills

Strong experience working in the pharma industry

Proven experience in teams/partnerships

Meeting tight deadlines

Ensuring GMP compliance

Education

Eligibility for nomination as Qualified Person

Job description

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.

What You Will Achieve

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.

How You Will Achieve It

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 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)

• E ligible 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 is required)

Purpose

Breakthroughs that change patients’ lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Benefits at Pfizer

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.

Our Competitive Benefits Programs help our colleagues by:

• 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 counseling 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 Pfizer 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 new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, 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 centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.