Senior Manager, Qualified Person

Use Your Power for Purpose 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 T he 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 manufactur er’s authorization in accordance with the requirements of Schedule 7 of The Hu m an Medicines Regulation s 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! Quality Assurance and Control