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.

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)

Division

Operations

Business Unit

Quality

Location

China

Site

Changping County (Beijing)

Company / Legal Entity

CN06 (FCRS = CN006) Beijing Novartis Pharma Co., Ltd

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

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.

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