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&D Quality. Your team will include PV System and Process Leads, Therapeutic Area Quality Leads, and a Head of Clinical QA or of PV and Regulatory QA, depending on which complements your own background.

Hybrid (3 days a week on site), based in Maidenhead, UK, or King of Prussia, PA, with other global locations open to discussion

Why it matters

Bringing clinical and pharmacovigilance quality under one leader is a deliberate choice. Some of the most consequential risks sit at the interfaces between them: serious adverse event reconciliation, expedited reporting, and the safety information that reaches investigators and regulators. A single function can see these clearly and act on them. The role is also a chance to shape how quality is done, not just police it. With ICH E6(R3) moving the industry toward Quality by Design and risk-based quality management, you will set the strategy, operating model and standards for how the company protects participants and patients. You will keep the specialist depth that GCP and GVP each need while making the approach consistent worldwide.

What You’ll Be Responsible For

You will provide independent, risk-based QA oversight from trial design through close-out, and across the global pharmacovigilance system. You will be the consistent quality voice in governance and a constructive challenger to the functions that own operational delivery.

• Setting the strategy, operating model, governance, capabilities and global resource model for Clinical QA and PV QA, harmonising approaches without diluting specialist expertise
• Embedding Quality by Design, critical-to-quality factors and risk-based quality management, and making sure risks to participant safety, patient safety and data integrity are escalated in time
• Assuring the quality systems behind clinical development and pharmacovigilance, including their integration with the enterprise QMS and accurate representation in the Pharmacovigilance System Master File
• Overseeing the clinical safety interfaces: SAE collection and reconciliation, SUSAR and expedited reporting, investigator safety reporting, safety data exchange agreements and signal escalation
• Running a globally consistent framework for significant quality issues, serious breaches, critical deviations and CAPAs, backed by rigorous root-cause analysis and reportability assessment
• Leading GCP and GVP inspection readiness and health-authority inspections, owning the patient-facing audit plan, and giving senior leadership an integrated view of quality risk, trends and regulatory intelligence

Experience Required

• 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 an advantage)
• Significant QA leadership in clinical quality, PV quality or both, including leading global teams in a complex matrix; 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus