Job Description
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. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.
To support our growth, we’re now looking for a collaborative, driven and proactive Quality Manager. You will be managing a UK based team of four and take a leading role in upholding the highest standards of product quality and compliance. You’ll ensure that all Quality operations run seamlessly and meet the rigorous requirements of GxP regulations, Clinigen Quality Systems and global industry standards.
Key Responsibilities:
1. Take ownership of Clinigen’s quality and technical activities as a global Marketing Authorisation Holder (MAH).
2. Lead relationships with Contract Manufacturing Organisations (CMOs), distributors, and quality partners worldwide.
3. Oversee quality investigations, including product complaints, deviations, CAPAs, and change controls.
4. Manage key quality documentation such as Product Quality Reviews (PQRs), master batch records, and product files.
5. Coordinate product stability programmes...