(Senior) Quality Manager (mfd)

Job Description 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 and is conducted according to the relevant Standard Operating Procedures. The (Senior) QAM provides strategic QA oversight drives quality decision-making and ensures timely delivery of GMP documentation batch release (as applicable) and project milestones. Acts as key interface for stakeholders and external partners (CMOs) as applicable ensuring robust audit readiness effective CAPA management and alignment of quality standards. Leads risk-based quality assessments and supports inspections and audits. Contributes expert guidance to cross-functional teams to ensure consistent compliant and efficient quality operations.

Job Description

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 cross-functional teams.
• Perform review approval and release of GMP-relevant deliverables can include batch disposition for clinical trial materials (IMP) in accordance with defined authorities.
• Can oversee the review of master and executed batch records ensure timely clarification of GMP deficiencies and supervise appropriate follow-up actions.
• Author review and approve GMP documentation (e.g. CoAs BRR checklists SOPs Quality Risk Assessments) ensuring completeness accuracy and compliance.
• Can provide QA support to project teams and contribute as an active project team member as applicable.
• Can 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.
• Can 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 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 new modality pharmaceutics 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 proven ability to assess GMP compliance
• Strong decision-making organizational and project management skills
• Effective communication leadership and stakeholder management

Languages

• Fluent 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 representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Required Experience:

Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1