Senior PV Quality Manager (Pharmaceutical, Hellerup)

Job summary

This role involves overseeing and managing compliance, quality standards, GVP auditing, and training for Pharmacovigilance within a biopharmaceutical company. The position is based in Hellerup, Denmark, and is part of a dynamic quality team.

Qualifications

• Degree in a scientific discipline.
• 5-10 years of experience in the pharmaceutical industry, with significant experience in GVP.
• Experience with quality systems, compliance monitoring, and development of SOPs and training programs.
• Proficiency in English (written and spoken).

Responsibilities

• Plan, perform, and report on GVP audits (internal, affiliate, and vendor/partner).
• Review and analyze audit, inspection, deviation, and CAPA data to identify trends and areas of exposure.
• Prepare compliance metrics and support regulatory inspections.
• Provide expert advice on GVP compliance and regulatory matters.
• Author and maintain GVP Quality procedures.
• Support PV vendor oversight and monitor PV Quality systems.
• Collaborate with SMEs on inspection responses and quality initiatives.

Skills

• Strong quality mindset and attention to detail.
• Excellent interpersonal, communication, analytical, and organizational skills.
• Ability to make responsible decisions to meet global GVP requirements.

Education

• Degree in a scientific discipline.

Tools

• Proficient in MS Office.