Senior PV Quality Manager, GVP Quality

Senior PV Quality Manager, GVP Quality

Ascendis Pharma

Hellerup, Denmark

Main areas of responsibility:

• Plan, perform, and report on GVP audits (internal, affiliate, and vendor/partner) in collaboration with GVP colleagues;
• Review and analyze audit, inspection, deviation, and CAPA data to identify root causes, trends, and areas of exposure;
• Prepare compliance metrics, conduct non-compliance investigations, and support regulatory inspections, including planning, execution, and follow-up;
• Provide expert advice on GVP compliance and regulatory matters, acting as quality partner to PV Operations (US/DK) and the EU QPPV;
• Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements;
• Support PV vendor oversight, including quality agreements and contracts, and proactively monitor PV Quality systems to identify risks;
• Collaborate with SMEs on inspection responses and quality development initiatives within the GVP area.

Qualifications and Skills:

You hold a master’s degree in a scientific discipline and have minimum 5-10 years of experience in the pharmaceutical industry with significant experience in GVP. You have experience as a GVP auditor and experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs. Experience with auditing computerized systems within the GPV regulated areas and medical device experience would be an advantage.

You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You are a highly motivated individual who enjoys being challenged and working in collaborative environments. You value inter-departmental team relationships using your excellent interpersonal, communication, analytical, and organizational skills.