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The Position

As an integral part of the local Quality Unit the QA Facility & Engineering team is dedicated to ensuring the qualified state of production facilities for the commercial manufacturing of drug substance materials at Roche in Basel. This team provides quality oversight for the cGMP-compliance status of all production equipment automation systems laboratory equipment building infrastructure utilities and IT/OT systems across four critical production areas: large-scale monoclonal antibody production medium-scale single-use technology for monoclonal antibody production antibody-drug conjugate production and synthetic molecule-based active substance production.

This vital role QA Manager for IT/OT Systems provides end-to-end quality oversight on the GMP-compliance status of both new and existing IT/OT systems within your assigned area of responsibility with a specific focus on Manufacturing Execution Systems (MES). You will serve as the crucial QA partner ensuring system integrity and regulatory adherence across diverse manufacturing and lab environments.

The Opportunity

• Provide Quality Oversight: Have end-to-end quality oversight on the GMP-compliance status of new and existing IT/OT systems especially MES within your assigned area of responsibility.

• Assure GMP-Compliance: Proactively provide QA input to assure GMP-compliance in projects and all system lifecycle activities.

• Act as QA Partner: Serve as the QA-partner for various functions related to key systems including legacy MES (Simatic IT) future MES (Rockwell Pharmasuite) sLims (LabWare7) SAP S/4HANA and various embedded systems in production and labs.

• Perform Review and Approval: Act as the QA reviewer and QA approver of GMP-records in the areas of Technical Change Control Deviation Management and CAPAs as well as CSV deliverables and Standard Operating Procedures (SOPs).

• Coordinate Investigations: Coordinate and facilitate complex deviation investigations root cause analyses and technical risk assessments.

• Manage Audits/Inspections: Present complex topics during health authority inspections and internal audits alongside partners from various functions.

• Mentor and Remediate: Mentor technical experts in their inspection preparation and presentation skills and orchestrate finding remediation if required.

Who You Are

• Education and Experience: University degree in life science or engineering and a minimum of 5 years of experience in Quality Assurance at a biologics manufacturing site.

• System and Process Expertise: Practical experience in Quality Oversight for major IT/OT systems and practical experience in Technical Change Control Deviation Management and CAPAs.

• Communication & Collaboration: Outstanding communication skills and mastery of teamwork in a diverse environment (QA Production QC IT Engineering Validation/Qualification) to drive collaboration with partners.

• Regulatory Acumen: Strong acumen across relevant GMP regulations (e.g. revised Annex 11 GAMP5 etc.) enabling you to drive quality awareness by integrating regulatory requirements analytical problem-solving and scientific rationale.

• Language Skills: Excellent German and English language skills both written and spoken.

Highly Desirable Experience: Any additional special experience and expertise is highly desirable (e.g. green field / brown field CAPEX projects implementation of new production or automation technologies (matrix) people leadership moderation of authority inspections PQS implementation projects etc.).

Ready for the next step We look forward to hearing from you. Apply now to discover this exciting opportunity!

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.