QA Manager Facility & Engineering (temporary 3 years)

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

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

That’s what makes us who we are. That’s what makes us Roche.

As part of the Quality Unit on-site, 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, and the utilities 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).

Key responsibilities

• You have end-to-end quality oversight on the qualified state of all assets in your assigned area

• You provide fit for purpose quality support for all the activities related to qualification & CSV, calibration, maintenance & reliability engineering

• You review and approve GMP records that cover technical change management, deviation management & CAPAs, risk assessments and SOPs

• You coordinate and facilitate complex investigations, root cause analyses, technical risk assessments, and continuous improvement projects

• With your operations partner 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 science or engineering with demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site.

• Practical experience in commissioning & qualification projects in highly automated GMP production facilities.

• Well established confidence in setting precise guidance for QA compliance in technical changes, deviations 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.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more .

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.