Senior PV Quality Manager/Associated Director, GVP Quality

Ascendis Pharma A/S; Denmark; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Ascendis Pharma A/S in Hellerup, Denmark, is seeking a Senior PV Quality Manager to lead our GVP Quality function. You will oversee audits, develop quality systems, and partner with PV Operations globally to ensure compliance with GVP standards.

The role reports to the Director, GVP Quality and involves reviewing CAPAs, supporting regulatory inspections, and training teams across Europe and the US. A science degree and 5–10 years in pharma with GVP experience are required; English fluency and

Qualifications

• Degree in a scientific discipline with significant pharma/GVP experience.
• Experience with quality systems, compliance monitoring, SOP development and training programs.
• GVP auditing experience is advantageous but not required; strong pharmacovigilance understanding is essential.
• Experience auditing computerized systems within GVP-regulated areas and medical devices is a plus.

Responsibilities

• Plan, perform, and report on GVP audits internal, affiliate, and vendor/partner.
• Review audit, inspection, deviation, and CAPA data to identify root causes and trends.
• Prepare compliance metrics and support regulatory inspections including planning and follow-up.
• Provide expert advice on GVP compliance and act as global quality partner to PV Operations and EU QPPV.
• Author and maintain GVP Quality procedures and support new or updated GVP requirements.
• Support PV vendor oversight including vendor qualification, quality agreements, and contracts.

Skills

GVP auditing

PV quality

Quality systems

MS Office

English proficiency

Education

Science/Pharma degree

Tools

Quality management systems

Job description

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.

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

For more details

about the job or the company, please contact Helle Virenfeldt Sall, Director, GVP Quality on Mobile + 45 53770506 or [e-mail].

You can learn more about Ascendis by visiting our website

All applications must be submitted in English and are treated confidentially.