Sr. PV Quality Manager, GCP and GVP Quality

Join the GCP and GVP Quality team in a leading and fast-growing Pharma company.

Ascendis Pharma is currently expanding its GCP and GVP Quality with a GVP auditor position.

In GCP and GVP Quality you will together with a growing & dynamic quality team take part in the oversight of the compliance, quality, standards, and training for Pharmacovigilance. You will maintain an up-to-date knowledge of regulatory requirements and ensure implementation of these in internal corporate procedures. Your primary area of responsibility will be the GVP area, including performance of GVP audits.

You will join a dedicated GCP and GVP Quality team located in Hellerup, Denmark and Palo Alto, USA, respectively. This role is based in Hellerup, Denmark and reports directly to the Director, GCP and GVP Quality based in Denmark.

Main areas of responsibility:

• Plan, perform, and report on GVP audits in collaboration with GVP colleagues (e.g., internal and vendor audits).

• Review and analyze audit, inspection, deviation and CAPA data to identify root cause, compliance trends and areas of exposure related to GVP.
• Prepare periodic compliance metric reports and conduct non-compliance investigations.
• Provide expert compliance and regulatory advice on GVP.
• Author and maintain procedures owned by GCP and GVP Quality.
• Support Regulatory Intelligence monitoring and assess impact and support implementation of new/updated GVP requirements on current practices and processes.
• Support the planning, conduct and follow-up on regulatory inspections.
• Collaborate with subject matter experts to formulate responses to inspection findings relevant to GVP.
• Supports quality development initiatives within the GVP area.
• Perform consultation on complex aspects of GVP.
• Perform the role of quality partner to PV Operation (US/DK) and the EU QPPV.
• Support the monitor PV Quality systems to proactively identify risk.
• Support PV Vendor oversight (e.g. quality agreements and other contracts)

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 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 of 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.

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.

Travelling: Approximately 20-30 days on a yearly basis.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.

For more details about the job or the company, please contact Helle Virenfeldt Sall, Director, GCP and GVP Qualityon Mobile + 45 53770506 or [email protected]. All applications must be submitted in English and are treated confidentially.

Applications will be evaluated when received, so please apply as soon as possible.