Quality Manager

500+ People are dedicated to maintaining the highest standards for Quality across GDD.
- In Technical Research & Development Quality Assurance, we strongly collaborate with our business partner to ensure that the TRD portfolio is delivered on time and with excellent quality and provide QA oversight and guidance to the local TRD facilities. We support innovation and product development throughout all clinical phases including transfer to the NTO organization and maintain the highest GMP standards to deliver novel therapies to our patients by ensuring their safety.
- The Quality Manager will provide quality assurance expertise, guidance, and support to various operational activities in Technical Research & Development (TRD) to ensure compliance with applicable regulatory requirements, Novartis procedures and quality standards.
- Your key responsibilities:

- Your responsibilities include, but are not limited to:
- Member of the TRD project teams and TRD sub-teams, representing QA for the assigned portfolio
- Release of Drug Substance and Drug Product batches, Intermediates and materials for world-wide clinical trials and issuance of corresponding batch certificates, under delegation of the Swiss FvP.
- Deviation and Change Control management for assigned portfolio
- Oversight on the review of master and executed batch records performed by the QA specialists, including clarification of all deficiencies in GMP documents, and supervision of agreed follow-up
- Write, review and complete GMP-relevant documents.
- QA Approver of GMP documentation owned by TRD according to internal procedures
- Support audits and inspections in case of questions on assigned portfolio
- Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management
- QA point of contact for assigned Contract Manufacturing Organisation (CMO) partners, support on-site visits and audit preparations at CMO, follows up audit CAPAs, and supports review of CMO KPIs and input to Quality agreements
- Support QA walkthroughs in various TRD facilities.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- What you’ll bring to the role:

- Essential:
- Bachelor’s degree with 5+ years’ experience or Master’s Degree with 3+ years’ experience in pharma Quality Assurance and operational areas.
- Good knowledge of cGMP, working knowledge in technical development or commercial manufacturing, production or analytics.
- Sound scientific, technical and regulatory knowledge.
- Strong organizational and decision-making skills, ability to work independently with little to no supervision.
- Strong and shown ability to analyse and evaluate cGMP compliance and product safety. Able to navigate in a regulated environment with the flexibility given to the development phase

Why Novartis?
- 766 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Novartis

**Division**
- Global Drug Development

**Business Unit**
- QA GDD

**Country**
- Switzerland

**Work Location**
- Basel

**Company/Legal Entity**
- Novartis Pharma AG

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No