Head Of Patient-Facing Quality Assurance

The Role Every clinical trial depends on a commitment to the people who take part: their rights, safety and wellbeing come first, and the data they help generate can be trusted. Once a product reaches patients, that commitment continues through the monitoring of its safety and benefit-risk. This role holds the organisation to both. As Head of Patient-Facing Quality Assurance, you will lead an integrated QA organisation covering Good Clinical Practice and Good Pharmacovigilance Practice, reporting to the Head of Global R experience across both GCP and GVP is strongly preferred Expert knowledge of GCP and GVP regulation 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 of Quality by Design, risk-based quality management, quality metrics, data integrity and computerised systems, as well as oversight of CROs, vendors, affiliates and partners Experience managing budgets, consultants, workforce plans and talent, and building a team of trusted strategic advisers Note on travel This is a global role. Expect some out-of-hours meetings across time zones and periodic international travel. About CSL Seqirus CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at . #J-18808-Ljbffr