Quality Specialist

Job description

Who We Are: Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. The Role: As a Quality Specialist within the Commercial Products Quality Assurance team, you will support the ongoing maintenance and operation of the Pharmaceutical Quality System (PQS). You will coordinate quality-related tasks and activities across internal teams and external partners, ensuring robust oversight of Clinigen Marketing Authorisation Holder (MAH) responsibilities. This role has a strong focus on maintaining GxP standards, regulatory compliance, and high-quality processes to ensure the safe and effective management of commercial products. Key Responsibilities: - Maintain and comply with Quality System requirements, including following and enforcing SOPs, job aids, company policies and GxP/GMP standards. - Manage core Quality Management System processes for Commercial Products, such as change controls, non‑conformances, quality complaints, and related...