ProClinical is working with a fast growing globally represented Biotech which is currently establishing its European production in Germany. This global biotech is seeking an Associate Director QA to be based in Frankfurt, Germany on a contract basis. The successful candidate will represent our Client at CMO's across Europe and ensure GMP compliance. This will include manufacturing, testing, transfers, validation readiness, deviations and investigations, change control and CAPAs, and regulatory submission.
- Serve as a Quality leader on site, help build quality systems and infrastructure as appropriate, and support implementation and review of quality procedures, methods, specifications, and reports as appropriate.
- Support and provide strong quality oversight and expertise for deviations, investigation, change controls, and CAPAs.
- Respond to and help facilitate/support technical and/or quality related issues.
- Support product manufacturing, validation, technology transfer, testing, and release in accordance with approved specifications and procedures.
- Monitor contractor compliance via documentation review and on-site presence.
- Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (small molecules and biologics).
- Participate in contractor quality audits and verify any actions taken by the contractor in response to audit observations are completed satisfactorily.
- Support and help facilitate Quality Technical Agreements between our Client and the contractor. Drive timely decisions, and facilitate active communication and information flow between contract manufacturer and our Clients team members.
- Provide Quality project manager support as needed for the program team.
Skills and Requirements:
- Broad knowledge of US/EU cGMPs for the pharmaceutical industry, with an understanding of global regulatory requirements.
- Experience in Quality Assurance with focus on manufacturing, validation, testing & release.
- Clinical (early and late phase) and commercial program experience is preferred.
- In-depth understanding of quality systems and current quality management tools.
- Attention to detail, good organizational skills, and the ability to multi-task effectively.
- Problem solving and technical writing skills.
- Work cross-functionally to ensure appropriate implementation and communication.
- Experience in a CMO environment is a plus
- Strong written and verbal communication skills.
- Fluent in English and German
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.