Npi QA Manager

vor 1 Woche

St Gallen, Schweiz Vifor Pharma Vollzeit

-CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.

We are currently looking for a NPI QA Manager in Zurich or St. Gallen (other CSL locations can be discussed). In this position you will be directly reporting to Head of NPI & Due Diligence Quality Management. You will be supporting new assets integration into CSL Vifor quality system/organization up to operations and representing quality function in corresponding cross-functional teams. In this function, you may also be supporting actively due diligence phase from a GxP compliance standpoint, identifying and reporting quality gaps and risks for new products/assets in integration phase, establishing remediation plan when possible.

**Key Tasks**
- Lead implementation of new assets (Drug Substance and/or Drug Product) within CSL Vifor Quality System
- Represent Quality in CSL Vifor Products Project Team (single point of contact)
- Ensure compliance until Market Launch for newly integrated assets, and provide the appropriate support during the handover to Operations
- Ensure Quality compliance for Managed and/or Early Access Programs, when required
- Manage deviations, OOx or any other findings during assets due diligence or integration
- Establish and/or review and approve corresponding Quality Documentation (i.e. Quality Agreement, MBRs, Validation protocols and reports, etc.)
- Supervise and/or conduct related Third-Party Audit
- Support due diligence performed on assets from Quality standpoint

**Qualifications**

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

**Minimum Requirements**
- Master’s degree in pharmaceutical sciences, Chemistry or Biology
- Proven experience in a Quality Control and/or in an analytical development department, including technical transfers know-how
- Knowledge in Drug Substance manufacturing (DP manufacturing is a plus)
- 3-5 years overall experience within Pharmaceutical or biotech industry or in chemistry
- Previous roles in interaction with external customers (CMO environment) or management of multi-sites operations
- Previous experience with product development up to commercial phase, manufacturing or technical transfer including analytical sections
- CMC dossier knowledge
- Good knowledge of Quality Systems and GxP
- Fluent English language skills

**Preferred Requirements**
- Exposed to international experience
- Leadership position in matrix organisation
- Additional languages of German and/or French is a plus

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