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The Position

IMP Quality Operations Switzerland is responsible delivering Investigational Medicinal Products (“IMPs”) to our patients in compliance with cGMP. We are the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and Compliance oversight of all.

Our purpose is to create a space for experimentation by coaching and celebrating learnings to build a purpose driven quality community that delivers innovative medicines to patients.

This position within IMP Quality Operations Switzerland requests a high level of flexibility, ability to work under pressure and sense of responsibility. If you have detailed knowledge of GMPs as well as outstanding interpersonal and negotiating skills, you should apply for this job.

Your opportunity

The role of the IMP QA Manager (IMP-QM):

• Acts as a delegate of the Swiss RP for IMPs
• Has the QA responsibility for GMP compliance of manufacture, analysis and release of parenteral IMP batches.
• Reviews and approves GMP procedures, records and reports (e.g. SOPs, master batch records, discrepancy and change records and validation reports).
• Reviews and approves process design project plans and reports.
• Performs self-inspections in GMP plants and laboratories.
• Reports directly to the RP and RP deputy.

The role of the IMP Quality Single Point of Contact (IMP-QSPOC):

• Is as a member of the technical development team (TDT) for early-stage IMPs the first contact in the TDT for QA related questions.
• Owns the product specification file (PSF), the supply-chain overview datasheets, the batch specific data sheet to ensure regulatory compliance of batches assigned to clinical studies and the intracompany product specific record (icPSR) that localizes relevant GMP activities and responsible QA functions for an IMP.
• Works in close cooperation with the IMP-QMs responsible for manufacturing, analyzing and releasing of batches.
• Provides Quality review for due diligence of IMPs prior to license in.

Who you are

• At least a Bachelor or Master Degree in Life Sciences or equivalent and a minimum of 5 years of relevant experience in the pharmaceutical industry.
• Demonstrated experience in a Pharmaceutical Technical Development environment
• Knowledge of cGMP and Quality requirements for clinical development stages of biotechnological and/or parenteral IMPs (e.g. EU Annex 1).
• Communication skills
• Ability to communicate clearly and professionally both verbally and in writing in English as well as in German.

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.

Roche is an Equal Opportunity Employer.