Job ID
REQ-10078724
June 02, 2026
Switzerland
Summary
Location: Basel, Switzerland #onsite
Role Purpose: The (Senior) Quality Manager is responsible for leading and overseeing quality activities across the TRD portfolio, ensuring compliance with cGMP, regulatory requirements, and the Novartis Quality Manual, all conducted according to the relevant Standard Operating Procedures. The (Senior) Quality Manager provides strategic QA oversight, drives quality decision-making, and ensures timely delivery of GMP documentation, batch release (as applicable), and project milestones. Acts as a key interface for stakeholders and external partners (CMOs), ensuring robust audit readiness, effective CAPA management, and alignment of quality standards. Leads risk-based quality assessments and supports inspections and audits while contributing expert guidance to cross-functional teams to guarantee consistent, compliant, and efficient quality operations.
About the Role
Major Accountabilities
- Manage complex projects and processes to support the TRD product portfolio, development activities, and departmental objectives in line with agreed timelines, quality standards, and regulatory requirements.
- Ensure sustained compliance with cGMP, internal quality standards, and health authority expectations across all assigned activities.
- Act as Subject Matter Expert (SME) and provide QA oversight and functional expertise to TRD line units and cross-functional teams.
- Perform review, approval, and release of GMP-relevant deliverables, which may include batch disposition for clinical trial materials (IMP), in accordance with defined authorities.
- Oversee the review of master and executed batch records, ensuring timely clarification of GMP deficiencies and supervising appropriate follow-up actions.
- Author, review, and approve GMP documentation (e.g., CoAs, BRR checklists, SOPs, Quality Risk Assessments) to ensure completeness, accuracy, and compliance.
- Provide QA support to project teams and contribute as an active project team member as applicable.
- Act as QA Single Point of Contact (SPOC) for assigned Contract Manufacturing Organizations (CMOs).
- Ensure alignment and harmonization of QA responses across TRD QA Operations.
- Serve as SAP/GLIMS key user and QA Operations SPOC for system-related topics.
- Support internal and external audits and inspections, ensuring readiness and effective responses.
- Ensure compliance with all relevant quality, safety, ethical, and information security standards.
Work Experience
- Experience in a GMP environment, preferably including QA.
- Experience in batch release, documentation review, and inspection support preferred.
- Experience in project management and cross-functional collaboration in a global matrix organization is highly desirable.
- Experience with GMP aspects of small molecules and new modality pharmaceuticals is a strong asset.
- Experience with external partners (e.g., CMOs) and supplier quality oversight is an asset.
Skills
- Strong knowledge of cGMP and regulatory requirements.
- Strong scientific, technical, and quality risk management expertise.
- Solid scientific and technical understanding of pharmaceutical processes.
- Analytical thinking with a proven ability to assess GMP compliance.
- Strong decision-making, organizational, and project management skills.
- Effective communication, leadership, and stakeholder management.
Languages
- Fluent in English (written and spoken).
- Local/site language (desirable).
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams that are representative of the patients and communities we serve.
Accessibility and Accommodation
Novartis is dedicated to working with and providing reasonable accommodations to all individuals. If you need a reasonable accommodation due to a medical condition or disability for any part of the recruitment process, please reach out via email at inclusion.switzerland@novartis.com and include the nature of your request along with your contact information. Please also provide the job requisition number in your message.
Why Novartis
Helping people with diseases and their families takes more than innovative science. It requires a community of smart, passionate individuals like you—collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn more here.
Benefits and Rewards
Discover the numerous ways we will support your personal and professional growth. Read our handbook (PDF 30 MB).
Division
Development
Business Unit
Quality
Location
Switzerland
Site
Basel (City)
Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
(Senior) Quality Manager (m/f/d)
Apply online using the form below.
Only applications matching the job profile will be considered.