Senior PV Quality Manager

3 days ago


Gentofte, Gentofte Kommune, Denmark Best Talent Full time

Company Overview

Ascendis Pharma A/S, a biopharmaceutical company founded in Copenhagen, Denmark in 2007, is dedicated to addressing unmet medical needs. The company utilizes its innovative platform technology to develop new and potentially best-in-class therapies, focusing on making a meaningful difference in patients' lives.

Headquartered in Copenhagen, Denmark, the company has offices in Heidelberg, Germany and California, US.

About the Role

We are seeking a Senior PV Quality Manager to join our growing team in Hellerup, DK. This exciting opportunity involves cross-functional collaborations and working with a well-functioning group where you will play an important role with your personality and competences.

Main Responsibilities

  • Plan, perform, and report on GVP audits in collaboration with GVP colleagues internally and with stakeholders.
  • 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 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.
  • Support 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 monitoring of PV Quality systems to proactively identify risks.
  • Support PV vendor oversight and qualification (e.g. quality agreements and other contracts).

Requirements

  • You hold a master's degree in a scientific discipline.
  • You have minimum 5-10 years of experience in the pharmaceutical industry with significant experience in GVP.
  • You are a GVP auditor with experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.
  • You are proficient in English at a professional level, both written and spoken.

Talent Acquisition

This is a confidential recruitment process, and we will handle your application in a professional manner. Please forward your application marked "1885/Senior PV Quality Manager".


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