Senior Manager CQA NL

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.

• 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; escalte resource or delivery risks in a timely manner.

• 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.
• Advise study teams on quality-by-design, critical-to-quality factors and proportionate, risk-based controls throughout study planning, conduct and close-out.
• Oversee the quality and integrity of trial documentation, including risk-based reviews of the electronic Trial Master File (eTMF) and related systems.

• Facilitate and challenge quality risk assessments; ensure significant risks are visible, owned, mitigated and monitored.
• Identify trends and systemic issues using quality metrics, audit outcomes and inspection intelligence; sponsor sustainable improvement actions.
• Assess the impact of new or revised regulations, guidelines and industry expectations and coordinate timely implementation within the quality system.

• Develop and maintain a risk-based audit program covering investigator sites, CROs, safety vendors, laboratories and other GxP service providers.
• Lead or oversee GCP, GVP and relevant GLP audits; communicate findings clearly and ensure timely, risk-appropriate remediation and closure.
• Maintain continuous inspection readiness through governance, mock inspections, document readiness, interview preparation and action tracking. Act as a lead CQA representative during regulatory inspections and health-authority interactions, coordinating responses and commitments.

• Serve as the primary CQA point of contact and trusted advisor for Clinical Development and operations, Pharmacovigilance, Regulatory Affairs and other relevant functions.
• Participate in cross-functional projects, providing independent quality judgement and escalating significant compliance or patient-safety concerns.
• Build effective quality relationships with external partners and suppliers; define expectations, performance measures and escalation pathways in quality agreements.
• Prepare concise quality updates, risk summaries and management reports for senior stakeholders and quality governance bodies.

• Master’s degree in life sciences, pharmacy, medicine or a related discipline, or a bachelor’s degree with substantial relevant experience.
• At least 8 years of experience in the pharmaceutical or biotechnology industry, including at least 6 years in Quality Assurance with significant GCP and/or GVP responsibility.
• Strong working knowledge of global GCP and GVP requirements and relevant clinical-development regulations and guidance, including expectations for data…