Role: Senior GCP Quality Expert
Location: Zurich, Switzerland
Albion Rye Associates are pleased to be 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 Senior GCP Quality Expert 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, the Senior GCP Quality Expert will work closely with the Clinical Development team to advise on all quality related GCP activities.
This is a fantastic opportunity to join a pioneering organisation during a key stage in their company development, offering a fast-paced working environment and chance to take ownership within the quality function from day one.
Main responsibilities (to include but not be limited to):
- Takes ownership of 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 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) 5+ years’ experience gained successfully managing quality issues within either a biotechnology or biopharmaceutical environment Proven track record of defining, implementing and maintaining Quality Management Systems Experience of managing the quality performance of internal functions, external service providers and external audits In depth knowledge of GCP requirements (biologics) and relevant industry and regulatory guidelines governing clinical trials in Europe and USA, and GLP and cGMP requirements related to the manufacture of biologics in the UK, Europe and USA Understanding of GLP and GMP requirements (biologics) Fluent in English. Additional languages are advantageous
Please note, we are unable to consider applicants who do not have the right to work in Switzerland.