Role: Associate Director Clinical Quality Assurance (GCP)
Location: Cambridge, UK or Remote, UK
We are working in partnership with a clinical-stage biopharmaceutical company focussed on revolutionising patient outcomes with their targeted approach to developing solutions within the field of immunology.
Playing a key role within the Global Quality Team, the successful Associate Director Quality Assurance will work closely with senior management to ensure that all quality processes and quality management systems are maintained and monitored closely as per company standards. In addition, you will work closely with the Clinical Development team to advise on all quality related GCP activities.
- Maintaining and monitoring the GxP Quality Management System (QMS), ensuring that the QMS meets all necessary regulatory requirements, with a specific emphasis on GCP compliance.
- Provides support and advice to the business with regards to the development and definition of GxP compliance procedures, management of quality issues, and monitoring of external contracted organisations and service providers.
- Responsible for the definition of and management of the GCP audit programme- perform GCP audits if required.
- Ensures that all quality metrics are maintained, and all compliance performance and potential risks are identified and communicated with the Senior Management team.
- Scientific degree (ideally Pharmaceutical Science; Biology; Chemistry; or similar)
- Proven track record of defining, implementing and maintaining Quality Management Systems
- In depth knowledge of GCP requirements (biologics) and relevant industry and regulatory guidelines governing clinical trials in Europe and USA.
- Understanding of GLP and GMP requirements (biologics)
- Fluent in English. Additional languages are advantageous