Senior Manager

Senior Manager CQA (Leiden, NL) Pharming Group n.V.
Posted on Aug 7, 2026
The role:
The Senior Manager Clinical Quality Assurance (CQA) provides strategic and operational leadership for clinical and pharmacovigilance quality. The role is accountable for independent GCP and GVP oversight, a risk-based quality management approach, inspection readiness and the effective operation of the clinical quality management system, in compliance with Pharming Sop's and all applicable regulations and guidelines (e.g. FDA, EU, ICH and national).
The Senior Manager CQA leads and develops the CQA team and partners with Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory Affairs and external service providers to safeguard participant safety, data integrity and regulatory compliance across the product lifecycle.
Areas of responsibility:
People leadership and team performance
• Lead, coach and develop the CQA team; establish clear objectives, roles, priorities and decision rights.
• Ensure team members are appropriately qualified and trained, with individual development plans and succession considerations.
• Create an inclusive, psychologically safe and high-performing environment in which workload, wellbeing, accountability and delivery are actively managed.
• Monitor capacity, timelines and performance indicators; escalate resource or delivery risks in a timely manner.
Clinical and pharmacovigilance quality oversight
• Provide independent GCP and GVP oversight for clinical development and pharmacovigilance activities, including oversight of outsourced activities.
• Own or oversee the review, approval and lifecycle management of clinical and pharmacovigilance quality-system documents, standards and procedures.
• Oversee the quality and integrity of trial documentation, including risk-based reviews of the electronic Trial Master File (eTMF) and related systems.
Quality risk, issues and continuous improvement
• Facilitat...