Imp Quality Manager

vor 1 Woche

Basel, Schweiz Work Selection Vollzeit

**Beschreibung**:
For our international partner based in Basel, we are looking for a qualified and motivated **IMP Quality Manager** for a temporary contract of 12 months with a possible extension.

IMP Quality Operations Switzerland is responsible for 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 in order to build a purpose driven quality community that delivers innovative medicines to patients.

**Tasks**:

- The role of IMP QA Manager is assigned as a delegate of the Swiss Responsible Person for IMPs in Basel and:

- Responsible for the lot disposition of IMP e.g. bulk drug product materials and active pharmaceutical ingredients (API)
- Ensures that the quality of the produced IMPs, manufactured by Technical Research and Development (TR&D) Basel, is in accordance with cGMP regulations
- Actively participates in compiling, reviewing and approving of Roche Pharma Quality System(PQS) standards
- Reviews and approves documents, e.g. Production Records, methods and specifications, change control documents, risk assessments, deviations and investigations
- Participates in internal as well as in external audits In the role of Q-SPOC you:

- Act as a single point of contact for the Technical Development Teams for Early State Products
- Lead the Quality Sub Team consisting of all IMP relevant QA functions are responsible to identify and communicate significant quality risks as well as to drive risk mitigation plan

**Must Haves**:

- Master degree or PhD in Life Sciences or similar degree
- Minimum 5 years of relevant experience in the pharmaceutical industry
- Demonstrated experience in a Pharmaceutical Technical Development environment (Small or Large Molecules or New Modalities)
- Knowledge of cGMP and Quality requirements for clinical development stages
- Strong leadership, communication and influencing skills
- Ability to communicate clearly and professionally both verbally and in writing in English as well as in German

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