 ##  [QA Operations Lead](/req-10083139-qa-operations-lead "QA Operations Lead") 

  Job ID REQ-10083139 

 

 Jul 22, 2026 

 

 LOC_CN 

 

 

 

###  About the Role 

Major Accountabilities:

- Functional Breadth, Critical Negotiations, People Leadership, Operations Management and Execution, Collaborating across boundaries, Project Management
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)

  
Key Performance Indicators:

- On-time &amp; GMP-compliant release of dosage forms
- No Complaints about inspections by authorities in your own area of responsibility without these being noticed &amp; communicated beforehand.
- Successfully Support continuous improvement Projects
- Executes batch release in compliance with registration
- As per local regulatory requirement and global guidance/SOP to set up local documentation hierarchy
- Quality system management (e.g., Change Control, Deviation, Audit &amp;Inspection, CAPA, QE, CONDO, etc.)
- Validation Batch Record review; Validation protocols review; Deviation management; On site Quality monitoring
- Support and oversight validation activities
- Audit and Inspection preparation and readiness
- Function representative to be involved in global and/or local project if any.
- Collaboration in GxP audits/inspections
- Oversight of Quality Operations
- Master Batch Record review and approval
- As site QP or delegation to release product
- QA for Quality Control &amp; AS&amp;T
- QA Operational Excellence

  
Work Experience:

- Good Manufacturing Practices (cGMP)
- Audit &amp; Inspection Management
- Release Management
- Quality Assurance
- Quality Compliance
- Quality Management Systems
- Technological Expertise

  
Skills:

- Collaboration
- Continuous Improvement mindset
- Dealing With Ambiguity
- Regulatory requirements knowledge
- Problem Solving Skills
- Leadership
- Communication skills
- Data Integrity
- Digital savviness

  
Languages:

- English.



 

###  Role Requirements 

 

**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](https://www.novartis.com/about/strategy/people-and-culture "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)](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf)



 

 

 

 

 

 Division DIV_TO 

 

 Business Unit Quality 

 

 Location LOC_CN 

 

 Site Haiyan (Zhejiang Province) 

 

 Company / Legal Entity CN27 (FCRS = CN027) Novartis Pharmaceutical Technology Zhejiang Co., Ltd. 

 

 Functional Area FCT_QA 

 

 Job Type Full time 

 

 Employment Type Regular 

 

 Shift Work No 

 

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 Job ID REQ-10083139 

 

 

###  QA Operations Lead 

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