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