Lead PV Quality Manager

22 hours ago


Gentofte, Gentofte Kommune, Denmark Best Talent Full time

Company Overview

Ascendis Pharma A/S is a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007. The company is committed to addressing unmet medical needs by applying its innovative platform technology to build a leading, fully integrated biopharma company.

The company continues to expand into additional therapeutic areas to address unmet patient needs and has offices in Heidelberg, Germany and California, US. For more information about Ascendis Pharma, please visit their website.

Salary and Benefits

The attractive remuneration package includes an estimated salary of $120,000 per year, short- and long-term incentives, pension, and health insurance. This position offers a highly competitive compensation package.

Job Description

The Senior PV Quality Manager will be responsible for maintaining an up-to-date knowledge of regulatory requirements and ensuring implementation of these in internal corporate procedures. This role involves planning, performing, and reporting on GVP audits, reviewing and analyzing audit data, and preparing periodic compliance metric reports.

The successful candidate will have a strong quality mindset, attention to detail, and excellent interpersonal, communication, analytical, and organizational skills. They will be able to make and take responsibility for decisions to meet the ever-growing and changing stringent global GVP requirements.

This is an exciting opportunity to join a fast-growing biopharmaceutical company with a strong pipeline and a dynamic GVP Quality team. As a person, you are a highly motivated individual who enjoys being challenged and working in a collaborative environment.

Required Skills and Qualifications

  • Master's degree in a scientific discipline
  • Minimum 5-10 years of experience in the pharmaceutical industry with significant experience in GVP
  • GVP auditor with experience in quality systems, compliance monitoring, and SOPs and training programs
  • Experience with auditing of computerized systems within the GVP regulated areas and medical device experience would be an advantage
  • Proficient in English at a professional level, both written and spoken

Benefits

You can expect around 30 traveling days per year as part of this role. The company offers a supportive work environment, opportunities for professional growth, and a positive company culture.

Application Instructions

Please forward your application marked '1885/Senior PV Quality Manager' to Best Talent. Read more about Ascendis Pharma on their website. We will interview candidates on an ongoing basis, so please apply as soon as possible.



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