摘要
-Leads the team for Quality in the site and works in strong collaboration with other members of the site leadership team.
About the Role
Core Responsibilities
Quality Leadership & Governance
- Lead and structure the site Quality organization to support all manufacturing operations
- Establish and maintain an effective Quality Management System (QMS)
- Drive quality governance, including Management Review and performance monitoring
- Own Manufacturing Quality Systems within the SM platform
Regulatory Compliance & Inspection Readiness
- Ensure full compliance across all products with regulatory and corporate quality standards
- Maintain continuous inspection readiness and audit compliance
- Manage regulatory registrations and authority interactions
- Lead internal/external audits and GxP inspection activities
Product Quality & Release
- Ensure quality across all manufacturing streams (solid, ophthalmic, aseptic)
- Approve batch release ensuring compliance with filings and specifications
- Approve Product Quality Reviews (PQR/APQR)
- Act as Qualified Person / Technical Responsible Person
Quality Systems & Risk Management
- Lead risk-based quality management and continuous improvement
- Ensure effective management of deviations, OOS/OOX, complaints, and recalls
- Act as escalation point for critical quality issues
- Monitor Key Quality Indicators (KQIs)
GxP Oversight & Change Management
- Provide oversight across all GxP processes
- Ensure compliant and timely handling of change controls
- Ensure data integrity, eCompliance, and regulatory adherence
Qualification, Validation & Equipment
- Ensure facilities, utilities, and equipment are qualified and maintained
- Ensure all products undergo appropriate process validation
Leadership & Culture
- Build and develop high-performing Quality teams
- Drive talent management, succession planning, and capability building
- Foster a culture aligned with Novartis values: Inspired, Curious, Unbossed
- Ensure workforce training and GMP qualification compliance
HSE & Business Continuity
- Promote strong Safety & Quality culture
- Ensure business continuity and crisis management readiness
- Participate in site emergency management as required
Key Accountabilities (China GMP Focus)
- Ensure effective operation of Quality Assurance & Quality Control systems
- Guarantee data integrity, traceability, and regulatory compliance
- Approve and oversee:
- Batch records and release
- Deviations, change controls, and investigations
- Validation, qualification, and technical documentation
- Ensure effective:
- Supplier qualification
- Stability programs
- Complaints and recall handling
- Lead periodic quality risk reviews and continuous improvement
Ideal Candidate Profile
Experience
- 12–15+ years in pharmaceutical QA/QC and/or manufacturing
- Strong experience in GMP, aseptic and solid dosage environments
- Proven leadership in operations, quality systems, and cross-functional collaboration
Education
- Degree in Pharmacy, Chemistry, Engineering, Biotechnology or equivalent
Languages
- Fluent English; local language preferred
Key Competencies
- Strategic leadership & change management
- Deep expertise in GxP quality systems
- Strong stakeholder engagement and regulatory interface
- Risk management & decision-making capability
- Communication and influencing skills
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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
