Head of Patient-Facing Quality Assurance
10 days ago
Maidenhead
The Role\n Join us in making a difference! Every clinical trial is built on a foundation of trust and commitment to the participants. Their rights, safety, and wellbeing are our top priorities, and the data they help generate must be reliable. As the Head of Patient-Facing Quality Assurance, you will play a pivotal role in ensuring this commitment continues even after a product reaches patients. You will lead an integrated QA organization that encompasses Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), reporting directly to the Head of Global R&D Quality. \n Your dynamic team will include PV System and Process Leads, Therapeutic Area Quality Leads, and a Head of Clinical QA or PV and Regulatory QA, tailored to complement your expertise. \n \n Location: Hybrid (3 days a week on-site), based in Maidenhead, UK, or King of Prussia, PA, with flexibility for other global locations. \n Why It Matters\n This role is not just about oversight; it’s about shaping the future of quality in clinical trials and pharmacovigilance. By bringing these two critical areas under one leadership, we can effectively address some of the most significant risks that arise at their intersections, such as serious adverse event reconciliation and expedited reporting. \n As we transition to a Quality by Design and risk-based quality management approach with ICH E6(R3), you will have the opportunity to set the strategy, operating model, and standards that protect our participants and patients while ensuring a consistent global approach. \n What You’ll Be Responsible For\n In this role, you will provide independent, risk-based QA oversight from trial design through to close-out, ensuring a consistent quality voice in governance and acting as a constructive challenger to operational delivery functions. \n\n • Developing the strategy, operating model, governance, and global resource model for Clinical QA and PV QA, harmonizing approaches while maintaining specialist expertise.\n, • Embedding Quality by Design principles, critical-to-quality factors, and risk-based quality management to ensure timely escalation of risks to participant and patient safety, as well as data integrity.\n, • Assuring the quality systems behind clinical development and pharmacovigilance, ensuring their integration with the enterprise QMS and accurate representation in the Pharmacovigilance System Master File.\n, • Overseeing clinical safety interfaces, including SAE collection and reconciliation, SUSAR and expedited reporting, investigator safety reporting, and signal escalation.\n, • Implementing a globally consistent framework for managing significant quality issues, serious breaches, critical deviations, and CAPAs, supported by rigorous root-cause analysis.\n, • Leading GCP and GVP inspection readiness, health-authority inspections, and owning the patient-facing audit plan, while providing senior leadership with an integrated view of quality risk and regulatory intelligence.\n\n Experience Required\n\n • At least 10 years of progressively responsible experience in pharma, biotech, or regulated life sciences, with a degree in life sciences, pharmacy, medicine, nursing, or a related discipline. An advanced degree or professional certification in Quality, GCP, GVP, or auditing is a plus.\n, • Significant QA leadership experience in clinical quality, PV quality, or both, including managing global teams in a complex matrix; experience across both GCP and GVP is strongly preferred.\n, • Expert knowledge of GCP and GVP regulations and inspection expectations, including ICH E6(R3) and the EU GVP framework.\n, • A proven track record with health-authority inspections, serious breaches, investigations, CAPAs, and inspection remediation.\n, • Hands-on experience with Quality by Design, risk-based quality management, quality metrics, data integrity, and computerized systems, along with oversight of CROs, vendors, affiliates, and partners.\n, • Experience in managing budgets, consultants, workforce plans, and talent, while building a team of trusted strategic advisers.\n\n Note on Travel\n This is a global role, which may require some out-of-hours meetings across time zones and periodic international travel. Embrace the opportunity to connect with colleagues around the world!