Senior GCP Quality Assurance Specialist
1 month ago
About the Role:
We are seeking a highly skilled Senior GCP Quality Assurance Specialist to join our growing team at Ascendis Pharma A/S. This is an exciting opportunity to work in a dynamic and international environment with a short line of command.
Job Description:
The Senior GCP Quality Assurance Specialist will be responsible for ensuring compliance with Good Clinical Practice (GCP) regulations and maintaining high-quality standards in clinical development and development operations. The successful candidate will collaborate with internal and external stakeholders, provide expert quality advice, lead subject matter experts, and participate in regulatory inspections.
Main Responsibilities:
- Collaborate with internal and external stakeholders to ensure implementation and maintenance of GCP processes.
- Provide day-to-day expert quality advice on GCP processes to clinical teams.
- Lead subject matter experts in maintaining current SOPs and initiating new procedures.
- Author and maintain SOPs owned by GCP Quality.
- Support Regulatory intelligence monitoring, assess impact, and implement new/updated GCP requirements.
- Participate in planning, conducting, and following up on regulatory inspections.
- Collaborate with subject matter experts to formulate responses to audit/inspection findings relevant to GCP.
- Support quality development activities within the Quality Management System.
- Perform expert consultation on complex aspects of GCP to project teams and departments.
- Monitor Quality systems to proactively identify risk.
- Support Clinical trial supply team with IRT design and operation.
Success Criteria:
The successful candidate will have a proven ability to drive compliance initiatives, meet stringent global GCP requirements, and demonstrate a strong quality mindset with attention to detail.
Requirements:
To be successful in this role, you will need a master's degree in a scientific discipline and at least 5 years of relevant experience in the pharmaceutical industry with significant experience in GCP from clinical quality & compliance. You will also need extensive experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.
What We Offer:
Ascendis Pharma A/S offers a competitive salary of approximately $120,000 per year, depending on experience, as well as a flexible working environment with opportunities for professional growth and development. You will work closely with experienced colleagues to advance our exciting product pipeline and contribute to the company's mission of making a meaningful difference in patients' lives.
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