Band

Level 6

Job Description Summary

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