Senior Manager, Clinical Quality Assurance & Audits

Pharming Group; Leiden; On-site; EUR 120,000 - 170,000; Full time

Benefits offered by this job

Competitive salary

8.33% holiday allowance

30 vacation days

Pension plan

Job summary

Pharming Group seeks a Senior Manager Clinical Quality Assurance to provide strategic and operational leadership for clinical quality and pharmacovigilance. You will lead the CQA team, ensure independent GCP/GVP oversight, and drive risk-based quality management across the product lifecycle.

You will partner with Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory Affairs and external providers, ensuring data integrity, participant safety and regulatory compliance, while

Qualifications

• Master’s degree or equivalent with life sciences focus.
• At least 8 years in pharma/biotech with 6+ years in QA (GCP/GVP).
• Strong knowledge of global GCP, GVP and regulatory guidance.
• Proven leadership of people and projects; line management preferred.
• Experience planning and conducting GCP/GVP audits and regulatory inspections.

Responsibilities

• Provide strategic and operational leadership for CQA across clinical and PV.
• Oversee GCP, GVP, and GLP audits; ensure timely remediation and closure.
• Maintain inspection readiness and lead regulatory interactions.
• Drive quality risk assessments and continuous improvement actions.
• Partner with Clinical Development, Medical Affairs, and Regulatory.

Skills

GCP oversight

GVP oversight

People leadership

Audit management

Quality risk management

Regulatory knowledge

Stakeholder management

Quality governance

Education

Master’s degree in life sciences/pharmacy/medicine

Bachelor’s with substantial relevant experience

Tools

eTMF platforms

Electronic quality-management systems

Audit management tools

Job description

Pharming Group seeks a Senior Manager Clinical Quality Assurance to provide strategic and operational leadership for clinical quality and pharmacovigilance. You will lead the CQA team, ensure independent GCP/GVP oversight, and drive risk-based quality management across the product lifecycle.

You will partner with Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory Affairs and external providers, ensuring data integrity, participant safety and regulatory compliance, while