About this role
Job title: QA Lead, CSPV (Pharmacovigilance)
About the Role The role provides strategic QA leadership within the CSPV function, aligning quality activities with the business strategy. You will partner with the Head of Global PV QA Americas to guide development project teams, drive proactive quality, and ensure regulatory compliance across CSPV programs, inspections, and CAPA management.
What You'll Do
- Facilitate the implementation of the quality strategy in close alignment with the CSPV business strategy and monitor its execution via an annual Quality Plan, risk assessments, and inspection readiness.
- Provide operational QA leadership for CSPV teams, including Quality Oversight for the Quality Plan execution, review of CSPV regulatory documents, Health Authority commitments, and the CAPA management process.
- Serve as the QA point person for CSPV matters, liaising with other GxP QA functions and CSPV leadership, and coordinating with CROs, partners and affiliates to ensure data quality and early issue detection/resolution.
- Lead PV inspections/audits, participate in risk management activities, RCA, CAPA development and closure, and escalation processes.
- Support regulatory inspection readiness and preparation; assist CSPV in handling deviations, investigations, and CAPA closures; facilitate lessons learned and process improvements.
- Keep abreast of regulatory changes and align Daiichi Sankyo policies and practices to maintain proactive compliance.
What We're Looking For
- Education: Bachelor's degree in Life Sciences, Pharmacy, or Medicines; Master's degree preferred.
- Experience: 7+ years in regulated activities, clinical development, PV and QA (or equivalent).
- Knowledge: Global Health Authority expectations; broad understanding of pharmaceutical product development; extensive GxP knowledge; GCP knowledge preferred; familiarity with FDA, EMA, ICH.
- Skills: Ability to engage with senior CSPV leadership; strong collaboration with CSPV, CROs, vendors and QA functions; leadership in investigations, CAPA management, risk-based decision making; strong communication.
- Travel: Ability to travel up to 20% of the time.