Head of Patient-Facing Quality Assurance

CSL

8d•Hybrid

About The Position

The Head of Patient-Facing Quality Assurance leads an integrated Quality Assurance organisation covering Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP). Reporting to the Head of Global R&D Quality, this global leadership role provides independent, risk-based QA oversight from clinical trial design through close-out and across the global pharmacovigilance system. The position serves as a consistent quality voice in governance and constructively challenges the functions responsible for operational delivery. The role sets the strategy, operating model, governance, capabilities and global resource model for Clinical QA and PV QA. It harmonises quality approaches worldwide while retaining the specialist expertise required for GCP and GVP. The Head embeds Quality by Design, critical-to-quality factors and risk-based quality management, and ensures risks to participant safety, patient safety and data integrity are escalated in a timely manner. The position oversees quality systems supporting clinical development and pharmacovigilance, including their integration with the enterprise QMS and accurate representation in the Pharmacovigilance System Master File. It also oversees clinical safety interfaces, including SAE collection and reconciliation, SUSAR and expedited reporting, investigator safety reporting, safety data exchange agreements and signal escalation. The role leads globally consistent frameworks for significant quality issues, serious breaches, critical deviations and CAPAs, supported by root-cause analysis and reportability assessment. It leads GCP and GVP inspection readiness and health-authority inspections, owns the patient-facing audit plan, and provides senior leadership with an integrated view of quality risk, trends and regulatory intelligence. The team includes PV System and Process Leads, Therapeutic Area Quality Leads, and a Head of Clinical QA or a Head of PV and Regulatory QA, depending on which complements the incumbent’s background. The position is hybrid, with three days per week on site, and is based in Maidenhead, UK, or King of Prussia, Pennsylvania; other global locations may be discussed. It is a global role involving some out-of-hours meetings across time zones and periodic international travel.

Requirements

At least 10 years of progressively responsible experience in pharma, biotech or regulated life sciences.
A degree in life sciences, pharmacy, medicine, nursing or a related discipline.
Significant QA leadership in clinical quality, PV quality or both, including leading global teams in a complex matrix.
Expert knowledge of GCP and GVP regulations and inspection expectations, including ICH E6(R3) and the EU GVP framework.
A track record with health-authority inspections, serious breaches, investigations, CAPAs and inspection remediation.
Hands-on experience with Quality by Design, risk-based quality management, quality metrics, data integrity and computerised systems.
Experience overseeing CROs, vendors, affiliates and partners.
Experience managing budgets, consultants, workforce plans and talent.
Willingness to participate in some out-of-hours meetings across time zones and periodic international travel.

Nice To Haves

An advanced degree or professional certification in Quality, GCP, GVP or auditing.
Experience spanning both GCP and GVP is strongly preferred.

Responsibilities

Set the strategy, operating model, governance, capabilities and global resource model for Clinical QA and PV QA.
Harmonise global QA approaches while maintaining specialist GCP and GVP expertise.
Embed Quality by Design, critical-to-quality factors and risk-based quality management.
Ensure risks to participant safety, patient safety and data integrity are escalated in a timely manner.
Assure quality systems supporting clinical development and pharmacovigilance, including integration with the enterprise QMS and accurate representation in the Pharmacovigilance System Master File.
Oversee clinical safety interfaces, including SAE collection and reconciliation, SUSAR and expedited reporting, investigator safety reporting, safety data exchange agreements and signal escalation.
Lead globally consistent processes for significant quality issues, serious breaches, critical deviations and CAPAs, with rigorous root-cause analysis and reportability assessment.
Lead GCP and GVP inspection readiness and health-authority inspections.
Own the patient-facing audit plan.
Provide senior leadership with an integrated view of quality risk, trends and regulatory intelligence.
Manage budgets, consultants, workforce plans and talent, and build a team of trusted strategic advisers.
Provide independent, risk-based QA oversight from clinical trial design through close-out and across the global pharmacovigilance system.
Act as a consistent quality voice in governance and constructively challenge functions responsible for operational delivery.