Associate III, Global External Quality a Luterbach

For our client, a biotech company in the Zug area, we are looking for a

Associate III, Global External Quality

Contract: until end June 2021 with the possibility of extensionStart date: asap

Responsibilities

• Change Control: ensure the timely and correct progression of change control for selected products at different stages (e.g. API, DS DP and FG) and across modalities (i.e. LM, SM, Biosimilars etc)
• Manufacturing: provide quality support for the manufacture of products at Contract Manufacturer Organizations (CMOs)
• Quality System: ensure that the CMO maintains quality systems that are in a state of compliance. Support QMR organization with all contract manufacturing organizations in Biogen International. Ensure documentation management (periodic review of procedures, ad-hoc update of procedures, archival of relevant documentation in the electronic document management system…) and process improvement (e.g. of CMO assessment, Quality Agreement template management …)
• Key Performance Indicators (KPIs) : collect and perform trend analysis based on indicators as well as feedback from other departments (for example Release, External Manufacturing).
• Support the quality team to perform the periodical evaluation of the performance of CMOs and in collaboration with other concerned departments.
• Prepare, draft sections of Annual Product Review Reports of selected products
• Prepare, draft updates Quality agreements with manufacturing and testing partners for clinical and commercial products or Logistics Service Providers and warehouses.
• Deviation, Complaints & CAPA: ensure the timely and appropriate investigation, impact assessment, close out with involving partners and contractors. Ensure appropriate corrective and preventive actions are defined, implemented, and that their efficacy is evaluated.

Qualifications

• Minimum Bachelor’s degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
• A minimum of 2 years of experience in a similar position in pharmaceutical or biotechnology industries i.e. with hands-on expertise in change control management preferably at Finished Good level.
• Relevant experience in either manufacturing, development, quality, or regulatory;
• Understanding of cGMPs, quality systems and regulations (FDA and EU, knowledge of Chinese or other geographies’ regulations is a plus);
• Knowledge of medical device regulations and manufacturing is a plus.
• Knowledge of Oracle Agile or Trackwise is a plus
• Organization skills, written, and verbal communication skills.
• MS Office proficiency. Understanding of cGXPs, quality systems, and regulations (FDA and EU, knowledge of Chinese or other geographies’ regulations is a plus).
• Knowledge of medical device regulations and manufacturing is a plus.
• Fluent in English