QA Manager Operations

Novartis AG

East Hanover, NJ

JOB DETAILS
SKILLS
Adobe Acrobat, Adverse Events, Change Control, Condominiums, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Disease, Documentation, English Language, GMP (Good Manufacturing Practices), GxP, Leadership, Legal, Management Reporting, Marketing, Negotiation Skills, Operations Management, Performance Metrics, Product Control, Project/Program Management, Quality Assurance, Quality Control, Quality Management, Regulatory Requirements, Standard Operating Procedures (SOP), Systems Administration/Management, Time Management, Validation Plan
LOCATION
East Hanover, NJ
POSTED
3 days ago

Job ID

REQ-10083139

Jul 22, 2026

China

Available in: English

Summary

  • Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures

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 receiptDistribution of marketing samples (where applicable)Key Performance Indicators:On-time & GMP-compliant release of dosage formsNo Complaints about inspections by authorities in your own area of responsibility without these being noticed & communicated beforehand.Successfully Support continuous improvement ProjectsExecutes batch release in compliance with registrationAs per local regulatory requirement and global guidance/SOP to set up local documentation hierarchyQuality system management (e.g., Change Control, Deviation, Audit &Inspection, CAPA, QE, CONDO, etc.)Validation Batch Record review; Validation protocols review; Deviation management; On site Quality monitoringSupport and oversight validation activitiesAudit and Inspection preparation and readinessFunction representative to be involved in global and/or local project if any.Collaboration in GxP audits/inspectionsOversight of Quality OperationsMaster Batch Record review and approvalAs site QP or delegation to release productQA for Quality Control & AS&TQA Operational ExcellenceWork Experience:Good Manufacturing Practices (cGMP)Audit & Inspection ManagementRelease ManagementQuality AssuranceQuality ComplianceQuality Management SystemsTechnological ExpertiseSkills:CollaborationContinuous Improvement mindsetDealing With AmbiguityRegulatory requirements knowledgeProblem Solving SkillsLeadershipCommunication skillsData IntegrityDigital savvinessLanguages:English.

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-cultureBenefits 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

Haiyan (Zhejiang Province)

Company / Legal Entity

CN27 (FCRS = CN027) Novartis Pharmaceutical Technology Zhejiang Co., Ltd.

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

Accessibility and accommodationNovartis 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.

Quality Operations China

Job ID

REQ-10083139

QA Manager Operations

Apply to Job

Job ID

REQ-10083139

QA Manager Operations

Apply to Job

About the Company

N

Novartis AG

Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1996