Lead the site quality organization to ensure regulatory compliance, product quality, and operational excellence across all manufacturing activities, in alignment with cGMP, ISO standards, and Novartis quality policies.
Job Description
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
Skills Desired
Analytical Thinking, Business Acumen, Business Strategy, Collaboration, Communication Skills, Data Integrity, Decision Making, Digital saviness, Finance Acumen, Industry standards Knowledge, Leadership, Organizational Saviness, Risk Management, Smart Risk Taking, Stakeholder Management, Storytelling, Strategic Planning, Strategic Thinking
