QA Site Manager (m/f)

REFERENZNUMMER:

375965/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Quality manager