QA Manager Facility & Engineering (temporary 3 years)

at  Roche

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The Position
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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

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