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The Position

Creating a future where we all have more time with the people we love.

As part of the local Quality Unit, the team QA Facility & Engineering ensures GMP compliance of all production facilities at the Basel Drug Substance Manufacturing site. The team's responsibilities include the quality oversight of the qualification status of all production equipment, automation systems, laboratory equipment, the building infrastructure, the utilities, IT systems and OT systems of all four production areas on-site (large-scale production of monoclonal antibodies; medium-scale single-use technology for production of monoclonal antibodies;  production of antibody-drug conjugates; production of synthetic molecules active substances).

Your opportunity

• You have end-to-end quality oversight on the GMP-compliance status of all new & existing production assets in your assigned area of responsibility

• You provide QA input to assure GMP-compliance in engineering projects and equipment lifecycle activities

• You are the QA partner for various functions related to commissioning & qualification of production equipment and process automation, asset reliability & maintenance and calibration. 

• You review and approve SOPs and GMP-records in the areas of Technical Change Control, Deviation Management and CAPAs.

• You coordinate and facilitate complex deviation investigations, root cause analyses and technical risk assessments.

• With your partners from various functions you present topics during health authority inspections and internal audits.

Who you are

To successfully fill this role, you bring the following qualifications:

• University degree in life science or engineering 

• Minimum of 5 years of experience in Quality Assurance at a biologics manufacturing site.

• Practical experience in Commissioning & Qualification of production equipment

• Practical experience in Technical Change Control, Deviation Management and CAPAs.

• Your collaboration with partners is characterized by outstanding communication and team work. You manage to drive quality awareness with operations partners at all levels by integrating regulatory requirements, analytical problem solving and scientific rationale.

• Excellent German and English language skills, both written and spoken.

• Any special experience and expertise is highly desirable: green field CAPEX projects, implementation of new production or automation technologies, zone concepts in biotech manufacturing, (matrix) people leadership, etc.

Are you interested, apply now!

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.