CQA Senior Manager: Clinical Quality & PV Oversight

Pharming Technologies B.V.; Leiden; On-site; EUR 120,000 - 160,000; Full time

Benefits offered by this job

8.33% holiday allowance

30 vacation days

Pension plan

Job summary

Pharming Technologies B.V. in Leiden seeks a Senior Manager Clinical Quality Assurance to provide strategic and operational leadership for clinical and pharmacovigilance quality.

You will ensure GCP/GVP oversight, risk-based quality management, and inspection readiness across the product lifecycle. You will lead the CQA team, partner with Clinical Development, Regulatory, Pharmacovigilance and external vendors to safeguard participant safety, data integrity and regulatory compliance.

Qualifications

• Master’s degree in a life sciences field or related discipline with extensive QA expertise.
• Minimum 8 years in the pharmaceutical/biotech industry with GCP/GVP responsibility.
• Strong knowledge of global GCP/GVP requirements and regulatory guidance.
• Experience leading teams and managing cross-functional projects.
• Experience planning and conducting GCP/GVP audits and regulatory inspections.

Responsibilities

• Provide independent GCP and GVP oversight for clinical development and pharmacovigilance activities.
• Own and oversee lifecycle management of QA documents, standards and procedures.
• Advise study teams on quality-by-design and risk-based controls.
• Oversee eTMF quality and trial documentation.
• Lead risk assessments and drive continuous improvement.
• Manage audit programs and vendor oversight; ensure timely remediation.

Skills

GCP/GVP knowledge

Audits

People leadership

Regulatory compliance

Communication

English language skills

Education

Master’s degree in life sciences / pharmacy / medicine

Bachelor’s degree with substantial relevant experience

Tools

eTMF platforms

Electronic Quality Management Systems (QMS)

Job description

Pharming Technologies B.V. in Leiden seeks a Senior Manager Clinical Quality Assurance to provide strategic and operational leadership for clinical and pharmacovigilance quality.

You will ensure GCP/GVP oversight, risk-based quality management, and inspection readiness across the product lifecycle. You will lead the CQA team, partner with Clinical Development, Regulatory, Pharmacovigilance and external vendors to safeguard participant safety, data integrity and regulatory compliance.