Description
QA Site Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Main tasks:
- Single point of contact (SPoC) for Quality and Compliance between the CMO and the company
- Negotiate and maintain Quality Agreements and Product Specific Requirements between the company and the CMO
- Participate in CMO regulatory health authority inspections and the company’s compliance audits, as needed
- Quality Lead in Technical Transfers to the CMO
- Manage CMO with regard to compliance and product quality
- Perform quality risk assessments, develop mitigation plan and follow-up on implementation
- Monitor and report quality performance of the CMO
Main qualifications
- Minimum BS degree. MS, PhD in chemistry, biology, pharmacy, engineering or other life science preferred
- Experience in execution of quality operations and processes in the pharmaceutical industry required
- Experience in drug product / drug substance manufacturing Small Molecules and/or Biologics preferred
- Strong quality orientation with knowledge of cGMPs (FDA; EMA, Swiss Medic, Anvisa, JP) regulatory guidelines and validation practices; track record of successful regulatory
- Communication and presentation skills (English must, German or French beneficial)
- Ability to travel ca. 20% of the time, mainly in Europe
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.