Quality Manager
Quality Manager
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Salary Not Disclosed
1 Vacancy
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
IMP Quality Operations Basel is responsible for delivering Investigational Medicinal Products (IMPs) to our patients in compliance with cGMP. We are the Quality Partner for all Manufacturing and QC Units 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 Basel requests a high level of flexibility ability to work under pressure and sense of responsibility. If you have detailed knowledge of GMPs and of biological drug substance and/or parenteral drug product development for pharmaceutical purposes as well as outstanding interpersonal and negotiating skills you should apply for this job.
The 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 analysis and release of parenteral IMP batches.
Reviews and approves GMP procedures records and reports (e.g. SOPs discrepancy and change records and validation reports).
Reviews and approves process design project plans and reports.
Performs self-inspections in GMP plants and laboratories.
Has a direct technical reporting line 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 for IMPs product specification files (PSF) supply-chain overview datasheets batch specific data sheets (to ensure regulatory compliance of batches assigned to clinical studies) and intracompany product specific records (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 10 years of relevant experience in the pharmaceutical industry.
Demonstrated experience in a Pharmaceutical Technical Development environment
Extensive understanding of technical development FDA EMA ICH guidelines and cGMP requirements.
Detailed knowledge of cGMP and Quality requirements for clinical development stages of biotechnological and/or parenteral IMPs.
Excellent communication skills
Ability to communicate clearly and professionally both verbally and in writing in English as well as in German.
Bereit fr den nchsten Schritt Wir freuen uns darauf von dir zu hren. Bewirb dich jetzt um diese spannende Mglichkeit zu entdecken!
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.
Roche is an Equal Opportunity Employer.
Required Experience:
Manager
Employment Type
Full-Time
