Senior GCP Quality Specialist

1 month ago


Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

About the role

We are seeking a skilled Senior GCP Quality Specialist to join our GCP Quality team at Ascendis Pharma A/S. As a key member of our team, you will be responsible for ensuring compliance with global GCP requirements and maintaining high-quality standards in our clinical development operations.

Main responsibilities

  1. Collaborate with internal stakeholders to implement and maintain GCP processes.
  2. Provide expert quality and compliance advice on GCP processes to clinical teams.
  3. Lead subject matter experts in maintaining current SOPs and developing new procedures.
  4. Author and maintain SOPs owned by GCP Quality.
  5. Support regulatory intelligence monitoring and implementation of new/updated GCP requirements.
  6. Participate in regulatory inspections and formulate responses to audit/inspection findings.
  7. Support quality development activities within the Quality Management System.
  8. Perform expert consultation on complex GCP aspects to project teams and departments.
  9. Monitor Quality systems to proactively identify risk.

Requirements

You hold a master's degree in a scientific discipline and have a minimum of 5 years of relevant experience in the pharmaceutical industry with significant experience in GCP from clinical quality and compliance.

You have extensive 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.

You are a highly motivated individual who enjoys being challenged and working in collaborative environments.



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