Site Quality Head Changping

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

• 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

• 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

• 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

• 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)

• Provide oversight across all GxP processes
• Ensure compliant and timely handling of change controls
• Ensure data integrity eCompliance and regulatory adherence

• Ensure facilities utilities and equipment are qualified and maintained
• Ensure all products undergo appropriate process validation

• 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

• Promote strong Safety & Quality culture
• Ensure business continuity and crisis management readiness
• Participate in site emergency management as required

• 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

• 1215 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

• Degree in Pharmacy Chemistry Engineering Biotechnology or equivalent

• Fluent English; local language preferred

• 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