Senior Quality Assurance Manager, GCP

4 weeks ago

Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time
Job Title: Senior Quality Assurance Manager, GCP

Ascendis Pharma A/S is a leading biopharmaceutical company with a strong focus on developing innovative therapies for patients with unmet medical needs. We are seeking a highly motivated and experienced Senior Quality Assurance Manager to join our GCP Quality team in Hellerup, Denmark.

Main Responsibilities:

  1. Collaborate with internal and external stakeholders to ensure the implementation and maintenance of GCP processes.
  2. Provide expert quality and compliance advice on GCP processes to clinical teams.
  3. Lead subject matter experts in the maintenance of current SOPs and the initiation and development of new procedures.
  4. Author and maintain SOPs owned by GCP Quality.
  5. Support regulatory intelligence monitoring, assess impact, and support the implementation of new/updated GCP requirements on current practices and processes with relevant functions.
  6. Participate in the planning, conduct, and follow-up on regulatory inspections.
  7. Collaborate with subject matter experts to formulate responses to audit/inspection findings relevant to GCP.
  8. Support quality development activities within the Quality Management System.
  9. Perform expert consultation on complex aspects of GCP to project teams and departments.
  10. Perform the role of quality partner to assigned departments and project teams.
  11. Monitor Quality systems to proactively identify risk.
  12. Support our Clinical trial supply team with IRT design and operation.

Requirements:

  • Master's degree in a scientific discipline.
  • Minimum of 5 years of relevant experience in the pharmaceutical industry with significant experience in GCP from clinical quality and compliance.
  • Extensive experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.
  • Experience with computerized systems within GCP regulated areas and medical device experience would be an advantage.
  • Proficient in English at a professional level, both written and spoken.

About Ascendis Pharma A/S:

Ascendis Pharma A/S is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

What We Offer:

  • An exciting and challenging position in an entrepreneurial and international company with a short line of command.
  • The opportunity to work with highly skilled and experienced colleagues to advance our exciting product pipeline.
  • A competitive salary and benefits package.
  • The chance to make a meaningful difference in patients' lives.

How to Apply:

Please submit your application in English, including your resume and a cover letter, to Louise Moe Engström, VP, GCP and GVP Quality. We look forward to hearing from you

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