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Ascendis Pharma, a global biopharmaceutical company, is seeking an Associate Director, GCP Quality to join its growing team in Hellerup, Denmark. This role is critical to ensuring Good Clinical Practice (GCP) compliance and quality excellence across global clinical development programs.
You will report directly to the Senior Director & QP, Head of GCP Quality and work within a team of 4 colleagues. The position is based at the company's headquarters in Hellerup and involves significant travel (30–50 days per year) to conduct audits and support regulatory activities.
Key Responsibilities:
- Plan, perform, and report on GCP audits (internal audits, clinical trial site audits, and service provider audits)
- Review and analyze audit, inspection, deviation, and CAPA data to identify root causes, compliance trends, and areas of regulatory exposure
- Review and approve quality intakes, serious breach reporting, deviations, and corrective/preventive actions (CAPAs)
- Provide expert compliance and regulatory advice on GCP matters
- Author and maintain GCP Quality-owned procedures
- Support regulatory intelligence monitoring and assess the impact of new or updated GCP regulations
- Lead and support planning, conduct, and follow-up on regulatory inspections
- Collaborate with subject matter experts to formulate responses to GCP-relevant inspection findings
- Drive quality development initiatives within the GCP area
- Perform expert consultation on complex GCP aspects to project teams and departments
- Serve as a quality partner to assigned departments
About Ascendis Pharma:
Ascendis is a global biopharmaceutical company guided by core values of Patients, Science, and Passion. The company applies its innovative TransCon® technology platform to develop therapies addressing unmet medical needs in endocrinology rare disease and oncology portfolios. The company operates from headquarters in Hellerup, Denmark, with research facilities in Heidelberg, Germany, and additional offices across Europe and the United States.
Requirements:
- Relevant academic degree, preferably a master's degree in life sciences
- Minimum 8 years of experience in GCP quality within the pharmaceutical industry
- Demonstrated experience as a lead GCP auditor of clinical trial sites and service providers
- Lead auditor certification (required)
- Strong working knowledge of drug development, clinical operations, regulatory authorities, and/or quality assurance
- Professional proficiency in English, both written and spoken
Key Competencies:
- Strong team player with excellent stakeholder management skills
- Proactive, solution-oriented mindset
- Thrives in dynamic environments and balances business needs with quality and compliance requirements
- Highly structured and analytical
- Ability to simplify complex issues into clear recommendations and actions
- Confident and effective communicator with stakeholders across global organizations
- Builds strong relationships based on trust, integrity, and collaboration
