QA Manager

Role Purpose:

As a QA manager of the QA Operational unit, manages complex projects and processes to support TRD drug development portfolio, drug production and/or life cycle management according to agreed objectives, timelines and standards. Ensure that compliance with cGMP is maintained in TRD.

Please note that experience in a technical R&D environment (pharma/chemical) is preferred.

Generic Activities:

• Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to the corresponding business partner (Line Unit) and other QA Units in area of responsibility
• Write, review, decide on approval and/or release of GMP-relevant deliverables in order to ensure compliance with cGMP internal quality standards.
• Perform project related activities, e.g. TRD products portfolio, operational processes, Quality Risk Assessments.
• Support Project management functions as a project team member.
• Provide Quality Oversight and support to TRD line functions in GMP related topics as per area of responsibility.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
• Area of responsibility: TRD QA Operations

Specific activities:

• Release of batches, materials and components for clinical trials with issuance of batch certificates, and approval of development documentation with the authority defined as per related governing SOPs, and with authorities delegated by the TRD Quality Team Head or QA Switzerland Site Head (FvP)
• 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 (e.g. CoAs, BRR checklists, SOPs, risk assessments).
• Supports audits and inspections in case of questions on assigned projects
• QA SPOC for assigned CMO. In this context, supports on-site visits and audit preparations at CMO, follows up audit CAPAs, and supports review of CMO KPIs and input to Quality agreements. Also responsible for collecting feedback from the various QA managers and support preparation of the Quality Risk Assess-ment (QRA). Is informed about deviations/OOX, general issues and changes at the CMO, and follows up at the corresponding meetings.
• Helps the QA managers and specialists for specific questions on CMO batch records/documentation and helps keeping harmonization of TRD QA Ops response.
• Depu tize for peers in the same area of responsibility

Experience/Professional requirement:

• Master\’s degree (5 years in pharma quality)
• Fluent German and English required (oral & written)
• Good knowledge of cGMP, working knowledge in technical development, production and QA.
• Sound scientific, technical and regulatory knowledge.
• Strong organizational and decision-making skills.
• Strong and proven ability to analyze and evaluate cGMP compliance.

Workload

100% (40 hours per week)

Role type: Onsite

Required start date: October 2025

Contract: 12 months

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation:

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at

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