Senior Quality Lead

About the role

Roche is seeking a Senior Quality Lead to join its Pharma Development Quality (PDQ) organisation. In this pivotal position you will design and deliver risk‑based quality assurance strategies for post‑approval products, affiliates and processes, acting as a trusted partner to senior business stakeholders.

Key responsibilities

• Design and implement QA strategies using the Critical to Quality (CtQ) framework across GCP, GVP and Medical Device areas.
• Define, plan and lead audits, leveraging data analytics to develop methodologies and managing the full audit lifecycle.
• Independently manage quality issues, track systematic findings and escalate significant risks to PDQ management.
• Evaluate quality positions, drive compliance action plans and lead high‑level risk presentations with business, legal and regulatory stakeholders.
• Lead preparation, staff training and execution of major Health Authority inspections (e.g., FDA, EMA).
• Contribute to PDQ’s long‑term strategic direction, lead compliance projects and mentor emerging Quality Leads.

Required profile

• Proactive, strategic thinker comfortable working in a collaborative, matrixed environment.
• Strong digital and data literacy with the ability to turn data into actionable insights.
• Extensive quality assurance experience in the pharmaceutical or medical device sector.

Required skills

• Critical to Quality (CtQ) framework
• Good Clinical Practice (GCP)
• Good Pharmacovigilance Practice (GVP)
• Medical Device regulatory knowledge
• Data analytics for audit methodology
• Audit planning and execution
• Health Authority inspection management (FDA, EMA)