Senior PV Quality Manager/Associated Director, GVP Quality

Are you passionate about GVP audits? Do you have a strong quality mindset? If so, now is your chance to join Ascendis Pharma as our new Senior PV Quality Manager. Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease portfolio. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets. Ascendis Pharma is currently expanding its GVP Quality with a GVP auditor/GVP QA position.

In GVP Quality you will together with a growing and dynamic quality team take part in the oversight and management of the compliance, quality, standards, GVP auditing and training for Pharmacovigilance. The GVP Quality team, is a part of the QA Development team with around 35 dedicated colleagues located in Hellerup, Denmark and Palo Alto, USA respectively. This role is based in Hellerup, Denmark and reports directly to the Director, GVP Quality based in 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 Global 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 vendor qualification, 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. Criteria for success in the role will be proven ability to make and take responsibility for decisions to meet the ever growing and changing stringent global GVP requirements.

Furthermore, a strong quality mindset and attention to detail in establishing priorities, scheduling, and meeting deadlines is essential. You hold a degree in a scientific discipline and have a minimum 5 -10 years of experience in the pharmaceutical industry, including significant experience in GVP.

You have

• experience with quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.
• While previous experience as a GVP auditor is an advantage, it is not a requirement.
• We are looking for someone with a strong understanding of pharmacovigilance and a genuine interest in auditing.
• Furthermore, experience auditing computerized systems within the GPV regulated areas and medical device 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.
• Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command.
• You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.
• Travel: Approximately 20-30 days on a yearly basis.
• Office:  Tuborg Boulevard 12, 2900, Hellerup Apply now.
• We evaluate applications when received, so we encourage you to apply as soon as possible.
• Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.    To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated.    For more details about the job or the company, please contact Helle Virenfeldt Sall, Director, GVP Quality on Mobile + 45 53770506 or [email protected].
• You can learn more about Ascendis by visiting our website  All applications must be submitted in English and are treated confidentially.
• A note to recruiters:  We do not allow external search party solicitation.  Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.  If this occurs, your ownership of these candidates will not be acknowledged.