Head of Patient-Facing Quality Assurance
1 day ago
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The Role\n Every clinical trial is built on a foundation of trust and commitment to the participants. Their rights, safety, and well-being 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 is upheld. You will lead an integrated QA organization that encompasses both Good Clinical Practice and Good Pharmacovigilance Practice, reporting directly to the Head of Global R&D Quality. \n Your dynamic team will include: \n\n • PV System and Process Leads\n, • Therapeutic Area Quality Leads\n, • A Head of Clinical QA or PV and Regulatory QA, tailored to complement your expertise\n\n This position offers a hybrid work environment (3 days a week on-site) based in either Maidenhead, UK or King of Prussia, PA, with flexibility for other global locations. Why It Matters\n Bringing clinical and pharmacovigilance quality under one leader is a strategic decision. Many significant risks arise at the intersections of these areas, such as serious adverse event reconciliation and expedited reporting. By having a unified function, we can address these challenges effectively. \n This role is not just about oversight; it’s an opportunity to redefine how quality is approached in our organization. With the industry moving towards Quality by Design and risk-based quality management, you will have the chance to set the strategy, operating model, and standards that protect our participants and patients while maintaining the necessary specialist depth in GCP and GVP. What You’ll Be Responsible For\n In this role, you will: \n\n • Provide independent, risk-based QA oversight from trial design through to close-out, and across the global pharmacovigilance system.\n, • Be the consistent quality voice in governance and a constructive challenger to operational delivery functions.\n, • Set the strategy, operating model, governance, capabilities, and global resource model for Clinical QA and PV QA, harmonizing approaches while preserving specialist expertise.\n, • Embed Quality by Design and risk-based quality management, ensuring timely escalation of risks to participant safety, patient safety, and data integrity.\n, • Assure the quality systems behind clinical development and pharmacovigilance, ensuring integration with the enterprise QMS.\n, • Oversee clinical safety interfaces, including SAE collection, SUSAR reporting, and safety data exchange agreements.\n, • Manage a globally consistent framework for significant quality issues, serious breaches, and CAPAs, supported by rigorous root-cause analysis.\n, • Lead GCP and GVP inspection readiness, owning the patient-facing audit plan and providing senior leadership with an integrated view of quality risk and regulatory intelligence.\nExperience Required\n To thrive in this role, you should have: \n\n • At least 10 years of progressively responsible experience in pharma, biotech, or regulated life sciences.\n, • 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 leading global teams in a complex matrix.\n, • Expert knowledge of GCP and GVP regulations, including ICH E6(R3) and the EU GVP framework.\n, • A proven track record with health-authority inspections, serious breaches, investigations, and CAPAs.\n, • Hands-on experience with Quality by Design, risk-based quality management, and oversight of CROs, vendors, and partners.\n, • Experience managing budgets, consultants, and talent, while building a team of trusted strategic advisers.\nNote on Travel\n This is a global role, which may require some out-of-hours meetings across time zones and periodic international travel.