St Gallen, St Gallen, Switzerland
The Global Head of Quality is responsible for leading Bachem’s newly established global quality organization, overseeing Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs (RA) across all GMP sites. Reporting directly to the Chief Operating Officer (COO), this role drives the strategic development, harmonization, and operational excellence of quality functions globally. The role leads approximately 700 FTEs through functional and/or regional quality leaders.
Heading the End to End operations for CSL Vifor and VFMCRP assets covering manufacturing, quality, supply chain, MS&T, engineering, chemical/pharmaceutical development, technical project management and digital center of excellence
Take over global Quality organization of Vifor Pharma with approx. 270 FTEs on 10 different international locations, covering all the quality attributes of all GXP areas
Take over the responsibility for global technical project management within Technical Operations. - Direct report line in global head of operations - Build up of the organization on the different sites - Line manager of the project managers on different sites which are implementing new or adapted pharmaceutical products on industrial scale for the whole range of pharmaceutical products (oral to parenteral) - Key contact on technical level, to our strategic partner in nephrology. - Heading of launch supply coordination of our key brands - Technical counterpart to different license partners - Technical due diligence for new assets
Coordination/Heading of a project manager team for the establishment of new pharmaceutical presentations for existing oral and parenteral products, including new innovative packaging materials which are not yet implemented in the respective therapeutic filed.
Heading of QC organization with raw Material, stabilty, API and finished product groups, dedicated stabilty Group and metrology group
Coordination, setup and approval of monitoring activities/data for different water qualities, clean room monitoring, media systems Establishment of SOP’s in the above mentioned areas and approval of qualification/validation. Planning and execution of FDA und Swissmedic Inspections for the media systems Lead of people in interdisciplinary working groups Core team member for reconstruction work in the facility from quality. International auditing of GMP contract manufacturers of oral and parenteral products.