about 1 month ago
A biotech facility with headquarters in Scandinavia is looking for a Quality Director & QP to join their team in the UK on a permanent basis. This company is at a very exciting stage as they are in preparation to conduct phase III trials. With plans for major growth they are expecting to forecast to be worth nearly USD 30 billion by 2030.
The position will be focusing on Director and QP related activities in support of the process through the Product Release Function and making sure that the products meet regulatory requirements.
Key responsibilities include but are not limited to the following:
- Responsible for the GMP compliance of key CMO activities
- Participate in regulatory inspections (FDA, national, EMA) within GMP, GLP, GCP, GDP
- The QP will approve all records generated by the business unit, including but not limited to batch records, laboratory certificates of analysis, deviations, validation documents and product quality review reports.
- Manages the batch disposition process to ensure timely release of products protocols, reports, including validation, annual review, and other quality documents from the CMOs
- Review and approve stability testing program and stability studies
- Perform audits
- Work closely with other cross-functional departments, such as CMC, RA, and Clinical
If this role could be of interest or any questions, don’t hesitate to get in touch!