Senior Quality Assurance Specialist

1 month ago


Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time
Job Title: Senior Quality Assurance Specialist

Ascendis Pharma A/S is seeking a highly motivated and experienced Senior Quality Assurance Specialist to join our GCP Quality team. As a key member of our team, you will be responsible for ensuring compliance with global GCP regulations and standards.

Main Responsibilities:

  1. Collaborate with internal and external stakeholders to ensure 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 development of new procedures.
  4. Author and maintain SOPs owned by GCP Quality.
  5. Support regulatory intelligence monitoring, assess impact, and implement new/updated GCP requirements on current practices and processes.
  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 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.

What We Offer:

  • An exciting and challenging position in an entrepreneurial and international company with a short line of command.
  • Opportunity to work with highly skilled and experienced colleagues to advance our exciting product pipeline.
  • 20-30 days of travel per year.
  • A wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.


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