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Qc And As&T Lead

8-10 years
Not Disclosed
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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