associate iii, global external quality in Luterbach

Barbara Sorce, Basel Professionals Health Care & Life Sciences
job type
apply now

job details

luterbach, solothurn
life sciences
job type
reference number
barbara sorce, basel professionals health care & life sciences
058 201 55 50

job description

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


  • 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.


  • 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