Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites.
Roche is an equal opportunity employer.
Head of MSAT Validation at Basel Biotech Manufacturing
Basel Biotech Manufacturing produces Biotech-APIs (Active Pharmaceutical Ingredients) for commercial and clinical supply. The Manufacturing, Science and Technology (MSAT) department is a support function within manufacturing.
As Head of the MSAT Validation Group, your are:
Accountable for oversight of the validation lifecycle from Plan to Retire, for manufacturing processes and equipment at Basel Biotech Drug Substance Manufacturing. This includes, but is not limited to oversight of Equipment, Facility, and Utility Qualification, Cleaning and Sanitization/Sterilization Validation, Process Validation, and administration of the Periodic Review and Revalidation program
Accountable for compliance with Health Authority requirements and the Roche Product Quality System. Represent validation program during health authority routine and pre-approval inspections
Leader of validation group within the MSAT department of Basel Biotech Manufacturing
Representative for the site in the Validation Network Team within the Roche Biologics Drug Substance Network
Coordinate validation work during technical transfer and launches of new products
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You have a University degree in a scientific or technical discipline, preferably in bioprocess or (bio-) chemical engineering.You bring the following qualification
8 or more years of experience in pharmaceutical or related industry
4 or more years experience in people management
Strong background in validation/qualification in biotech industry with knowledge of regulatory guidelines, health authority and cGMP (Good Manufacturing Practice) requirements.
Strong (intercultural) communication skills in spoken and written German and English
Ability to create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term