Quality Assurance Expert for Global Pharmacovigilance
14 hours ago
Established in Copenhagen, Denmark, Ascendis Pharma A/S is a U.S. publicly held biopharmaceutical company dedicated to addressing unmet medical needs. Guided by their core values of patients, science, and passion, the company leverages its innovative platform technology to develop new and potentially best-in-class therapies.
With a strong focus on making a meaningful difference in patients' lives, Ascendis Pharma continues to expand into additional therapeutic areas to address unmet patient needs. The company maintains offices in Heidelberg, Germany, and California, US.
Job OverviewThe Senior PV Quality Manager will join the GVP Quality team in a fast-growing biopharmaceutical company with a robust pipeline. This exciting opportunity involves collaborating with a global team based in Hellerup, DK.
- Collaborate with cross-functional teams to ensure seamless quality control processes
- Contribute to the development and maintenance of SOPs and training programs
- Participate in audits, inspections, and non-compliance investigations
- Plan, conduct, and report on GVP audits in collaboration with internal colleagues and stakeholders
- Review and analyze audit data to identify root causes, compliance trends, and areas of exposure
- Prepare periodic compliance metric reports and investigate non-compliance issues
- Provide expert advice on GVP regulatory requirements
- Author and maintain procedures owned by GVP Quality
To excel in this role, you must possess a Master's degree in a scientific discipline and at least 5-10 years of experience in the pharmaceutical industry with significant expertise in GVP. Proficiency in English at a professional level is essential, along with strong communication and analytical skills.
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