Qc And As&T Lead

Novartis

8-10 years

Not Disclosed

China

10 Dec. 5, 2024

Job Description

Job Type: Full Time Education: BE/BCS/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here’s a concise and engaging summary of the job description:

Quality Control Manager – China RLT Project
Location: Haiyan, Zhejiang Province, China

About Novartis:
At Novartis, we’re dedicated to advancing innovative science and fostering collaboration to improve patients' lives. Be part of a team driven by passion, purpose, and a shared vision for a brighter future.

About the Role:
As a Quality Control Manager for the China RLT project, you will lead QC activities to ensure compliance with cGMP, regulatory requirements, and Novartis corporate quality policies. You'll play a critical role in ensuring product quality and advancing operational excellence.

Key Responsibilities:

Execute and follow up on QC tasks per the project schedule; manage gap assessments and escalate issues as necessary.
Lead QC equipment qualification, analytical method transfers, and validations. Maintain QC utilities and manage lab safety stock to ensure no operational disruptions.
Manage stability samples and testing plans; complete testing for validation samples on time.
Develop and implement QC procedures, including SOPs, work instructions, and analytical methods.
Investigate and resolve OOX and deviations; act as an SME during audits and inspections.
Collaborate with global QC and Analytical Science & Technology (AS&T) experts to meet quality milestones.
Drive the introduction of new technologies and ensure adherence to GxP standards in QC activities.
Lead and coach a team of QC associates, ensuring GMP training compliance and career development alignment with business strategies.

Essential Requirements:

8–10 years of professional experience in GMP QC within the pharmaceutical industry, preferably in sterility product manufacturing.
University degree in Pharmacy, Engineering, Chemistry, Biotechnology, or equivalent.
Expertise in pharmacopoeias, GxP standards, and regulatory guidelines (e.g., FDA, EU, ICH).
Proficient in MS Office and IT tools supporting quality activities.
Strong analytical, leadership, and project management skills.

Desirable Skills:

Experience in analytical test method development, transfer, and validation.
Expertise in project management, operations, financial management, and cross-functional collaboration.
Fluent in English; proficiency in the local language is a plus.

Why Novartis:
At Novartis, improving lives takes more than innovative science—it requires a community of smart, passionate individuals working together to inspire breakthroughs.

Accessibility and Accommodation:
Novartis is committed to providing reasonable accommodations for individuals with disabilities. For support, email diversityandincl.china@novartis.com with the job requisition number.

Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Job Type: Full-Time, Regular

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