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R&D Quality Manager

10+ years
Not Disclosed
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

R&D Quality Manager

Location: India
Job ID: REQ-10028790

Company: Novartis Healthcare Private Limited
Functional Area: Quality
Job Type: Full-time

About the Role

The R&D Quality Manager is responsible for managing technical complaints related to Investigational Medicinal Products (IMPs) and Medical Devices. The role involves investigating complaints, addressing data integrity issues, and contributing to global Data Integrity (DI) initiatives while maintaining compliance with regulatory standards.

Key Responsibilities

  • Complaint Management:

    • Investigate technical complaints from clinical investigator sites.
    • Perform Root Cause Analysis (RCA) and implement corrective actions to prevent recurrence.
    • Approve complaints as the site investigation approver and manage multiple investigations simultaneously.
  • Data Integrity (DI):

    • Handle data integrity escalations and support incidents.
    • Participate in and contribute to global DI networks and initiatives.
  • Analysis & Reporting:

    • Analyze trends in technical complaints periodically to identify patterns.
    • Communicate roadblocks and ensure timely delivery of investigations.
  • Compliance & Audits:

    • Support audit and inspection readiness activities.
    • Ensure compliance with cGMPcGxP, and international regulatory regulations, including EU-GMPguidelines.

Essential Requirements

  • Experience:

    • Over 10 years of practical experience in the chemical/pharmaceutical industry, or 5+ years in pharmaceutical operations.
    • Strong expertise in cGMP manufacturingQuality, and Compliance.
    • Proficiency in managing investigations for small moleculesbiologicscell and gene therapy (CGT)products, medical devices, and packaging/distribution topics.
  • Skills:

    • Root Cause Investigation: Capable of conducting and completing RCAs efficiently.
    • Strong problem-solving, planning, and analytical thinking skills.
    • Ability to manage tasks independently with minimal direction.
    • Effective project management, communication, and coaching abilities.
  • Knowledge:

    • Sound understanding of current international regulations and best practices in quality and compliance.
    • Familiarity with pharmaceutical facilities, manufacturing, and laboratory systems.

Why Novartis?

Novartis focuses on making breakthroughs in healthcare by fostering a collaborative, supportive community of passionate individuals. Be part of a team working to create a brighter future for patients and their families.

Benefits and Rewards

Discover how Novartis supports personal and professional growth through its comprehensive Benefits and Rewards HandbookBenefits & Rewards Handbook.

Join the Novartis Network

Stay connected with career opportunities by joining the Novartis Talent NetworkNovartis Talent Network.