Senior GCP Quality Assurance Specialist
13 hours ago
Overview
Ascendis Pharma A/S is a fast-growing biopharmaceutical company with operations in Denmark, Germany, and the United States. We are dedicated to developing innovative therapies to address unmet medical needs.
Job Description
As a Senior GCP Quality Assurance Specialist, you will play a critical role in ensuring compliance with Good Clinical Practice (GCP) regulations. You will collaborate with internal and external stakeholders to implement and maintain GCP processes, provide expert quality and compliance advice to clinical teams, and lead subject matter experts in the maintenance of current Standard Operating Procedures (SOPs).
Responsibilities
- Collaborate with internal and external stakeholders to ensure appropriate GCP processes are implemented and maintained.
- Provide day-to-day expert quality & compliance advice on GCP processes to clinical teams.
- Lead subject matter experts in the maintenance of current SOPs and in the initiation and development of new procedures.
- Author and maintain SOPs owned by GCP Quality.
- Support Regulatory intelligence monitoring, assess impact and support implementation of new/updated GCP requirements on current practices and processes with relevant functions.
- Participate in the planning, conduct and follow-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 projects teams and department.
- Perform the role of quality partner to assigned departments & project teams.
- Monitor Quality systems to proactively identify risk.
- Support our Clinical trial supply team with IRT design and operation.
Requirements
To succeed in this role, you must have a master's degree in a scientific discipline and a minimum of 5 years of relevant experience in the pharmaceutical industry with significant experience in GCP from clinical quality & compliance. You should have extensive experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.
Benefits
As a Senior GCP Quality Assurance Specialist at Ascendis Pharma A/S, you will enjoy a challenging and rewarding career in an international biopharmaceutical company. You will work with highly skilled and experienced colleagues to advance our exciting product pipeline and contribute to making a meaningful difference in patients' lives.
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