Instagram
youtube
Facebook

Associate Manager - Quality Operations

6+ years
Not Disclosed
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences/BBA/MBA 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

Associate Manager - Quality Operations

Location: India
Job ID: REQ-10029448
Company: Novartis Healthcare Private Limited
Functional Area: Quality
Job Type: Full-time

About the Role

The Associate Manager - Quality Operations is responsible for ensuring quality services are delivered in compliance with cGMP and Novartis Quality Management System. The role focuses on managing the quality aspects of projects, overseeing quality operations services, and ensuring the timely and efficient execution of service deliverables.

Key Responsibilities

  • Quality Operations & Compliance:

    • Deliver Quality Operations services supporting product quality and regulatory workflows.
    • Manage accounts in workflow applications such as SAPDragon, and SUBWAY.
    • Generate, analyze, and follow up on predefined and ad-hoc reports (e.g., in AGILE PLMAQWA).
    • Ensure compliance with Novartis quality standardsregulatory requirements, and service level agreements.
  • Service Quality & Improvement:

    • Implement service quality and process improvement projects, and manage CAPA (Corrective and Preventive Actions).
    • Escalate service-related GxP and non-GxP issues for timely resolution.
    • Regularly collect feedback from customers and partners on support services.
  • Documentation & Training:

    • Create and review GxP documents such as SOPsworking procedures, and trend reports.
    • Ensure timely completion of relevant training.
    • Mentor and train new personnel for onboarding in Quality Operations.
  • Project & Stakeholder Management:

    • Lead new service or expansion projects, monitor progress, and report deviations.
    • Collaborate closely with global stakeholders and manage communication regarding project and service deliverables.
  • Audit Support & Reporting:

    • Provide support during internal and external audits, including collecting and presenting requested data.
    • Ensure adherence to service KPIs, and keep operational tools like dashboards and time sheets updated.

Essential Requirements

  • Education:
    • M.PharmMBAEngineering, or equivalent from a reputed institute.
  • Experience:
    • Minimum 6 years in Quality AssuranceRegulatory, or pharmaceutical manufacturing (drug substances/products/medical devices).
    • Expertise in LMS (Learning Management System) and broad IT knowledge.
  • Skills:
    • GxP knowledge, proficiency in MS-Office, and strong communication, presentation, and interpersonal skills.
    • Project management experience and ability to work with global stakeholders.

Why Novartis?

Novartis is committed to improving lives through innovative science, working as a passionate team to create breakthroughs in healthcare.

Benefits and Rewards

Explore all the ways Novartis helps its employees thrive in the Novartis Life HandbookNovartis Life Handbook.

Join the Novartis Network

If this role isn't suitable for you, stay connected to future opportunities by joining the Novartis Talent NetworkNovartis Talent Network.