(Senior) Quality Manager (m/f/d) at Novartis

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

10 Sep, 26

Salary

0.0

Posted On

12 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP, Quality Risk Management, Batch Release, Project Management, Stakeholder Management, CAPA Management, Audit Readiness, Pharmaceutical Processes, Regulatory Compliance, CMO Oversight, Analytical Thinking, Leadership, English Fluency, SAP, GLIMS, Documentation Review

Industry

Pharmaceutical Manufacturing

Description

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 inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Skills Desired Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

Lead and oversee quality activities across the TRD portfolio to ensure compliance with cGMP and regulatory requirements. Provide strategic QA oversight, manage batch release, and act as the primary interface for external partners and CMOs.