Associate Director Audit & Assurance R&D Q&A

Are you ready to raise the bar on GxP assurance and accelerate the delivery of life-changing therapies to patients? As a member of our independent second line function, you will shape how we assure quality across research and development so teams can move confidently and at pace. In this role, you will lead risk-based GVP and GCP audit programs, drive inspection readiness, and embed a proactive quality mindset that turns regulatory expectations into day-to-day excellence. Your work will enable faster, more reliable trials and robust safety oversight-directly influencing patient outcomes. Can you translate complex regulations into clear, pragmatic guidance that stands up to scrutiny and drives lasting improvement? You will partner across cutting-edge areas including digital health and technology, AI-enabled solutions, cell therapy, precision medicine and medical devices. With strong investment and a bold ambition to transform cancer care, you will connect science, technology and quality to deliver results that matter. Accountabilities:

• Risk-Based GVP/GCP Auditing: Plan, lead, conduct and report system, process and supplier audits across GVP and GCP, including for-cause audits, to surface critical risks and drive sustained improvements.
• Audit Program Leadership: Build and prioritize audit plans aligned to business risk; coordinate internal and outsourced audits; oversee external consultants to ensure consistency and quality of delivery.
• Supplier Qualification: Lead supplier qualification assessments; identify and assess gaps; agree remediation and follow through to verified closure to protect clinical and safety operations.
• CAPA Ownership: Assess the need for CAPAs, assist in development, approve plans and monitor to completion; manage significant CAPAs stemming from audit and inspection findings to proven effectiveness.
• Inspection Readiness and Management: Provide proactive inspection support; lead or support preparation and conduct of regulatory GxP inspections; deliver targeted training and readiness exercises; ensure timely, high-quality responses and follow-up.e
• Due Diligence Support: Contribute to quality due diligence for partnerships, vendors and acquisitions as assigned, informing sound business decisions.
• Quality Advice and Influence: Serve as GxP and quality system expert; provide responsive and pragmatic quality and compliance advice to stakeholders; use risk frameworks to define risks and develop mitigation recommendations.
• Process and Capability Building: Maintain current knowledge of regulations and industry trends; lead development or revision of QA processes, projects and tools; deliver training; mentor QA colleagues; promote a culture of ethics, integrity and continuous improvement.
• Cross-Functional Reach: Engage with teams in digital health and technology, AI solutions, cell therapy, precision medicine and medical devices to ensure fit-for-purpose oversight across evolving modalities.
• Travel: Travel as required to conduct audits and support inspections., Here you will join a focused, fast-moving mission where science meets technology to push the boundaries of what's possible for patients. We pursue earlier detection and earlier treatment, and we back bold ideas with the investment and cross-functional collaboration needed to deliver. You will work with unexpected teams in the same room-clinicians, data scientists, technologists and quality experts-unleashing sharp thinking that turns breakthroughs into medicines. We value kindness alongside ambition, and we empower people at every level to ask questions, take smart risks and deliver excellence that changes lives.
  
  Degree level education or equivalent experience
• Considerable experience in pharmaceuticals or a related industry
• Excellent analytical, written and oral communications skills
• High ethical standards, trustworthy, operating with absolute discretion
• Strong collaborative, influencing and interpersonal skills - curious to understand business environment
• Skilled at managing & using technology
• Ability to maintain and create professional networks with stakeholders
• Audit expertise
• Experience in managing regulatory health authority GxP Inspections
Desirable Skills/Experience:
• Supplier qualification
• Project management experience