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    Ecompliance Manager

    Novartis
    7-15 years
    Not Disclosed
    Hyderabad India
    10 Feb. 7, 2025
    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

    eCompliance Manager (Job Description)

    Role Summary:

    The eCompliance Manager is responsible for providing Quality Assurance oversight and guidance on Computerized Systems Validation (CSV), ensuring compliance with regulatory frameworks such as GxP, 21CFR11, and requirements outlined in the Novartis Quality Manual and global procedures. The eCompliance Manager plays a critical role in supporting GxP-regulated computerized systems projects, approving GxP impacted changes, periodic review reports, and deviations, as well as offering guidance on CSV-related topics.

    Location:

    Hyderabad, India

    Key Responsibilities:

    1. Quality Oversight and Support:

      • Oversee operational activities related to GxP systems, including changes, periodic reviews, and deviations.
      • Provide support to ensure compliance with Novartis and regulatory requirements for GxP-regulated computerized systems.
      • Act as the point of contact for all CSV-related matters concerning GxP systems.
      • Serve as an interface between IT and business functions for eCompliance topics related to GxP systems, promoting a quality culture.

    2. Document Review and Approval:

      • Review and approve project-related documents for GxP-relevant systems.
      • Assess GxP applicability for both GxP and non-GxP systems.
      • Approve GxP changes and related deliverables.
      • Review and approve GxP impacted deviations, ensuring appropriate corrective and preventive actions (CAPA) are implemented.

    3. Operational Support:

      • Establish and maintain a trusted partnership with the assigned IT function.
      • Contribute to the preparation and execution of Validation Master Plans (VMP).
      • Review and approve periodic review reports for GxP computerized systems and manage gaps within the CAPA Management System.

    4. Supplier and Audit Management:

      • Perform supplier qualification assessments.
      • Provide audit support and assist in CAPA management.

    Essential Requirements:

    • Ensure GxP-relevant computerized systems are developed, implemented, and maintained according to Novartis requirements.
    • Timely review and approval of changes, deviations, and periodic review reports for GxP systems.
    • Maintain up-to-date documentation supporting eCompliance and CSV requirements, ensuring it is audit-ready.
    • Proactively identify gaps in eCompliance and CSV activities and escalate issues, supporting the development of mitigation plans.
    • Achieve high levels of client and stakeholder satisfaction.

    Desirable Requirements:

    • 10-15 years of IT experience, with at least 7 years in regulated functions (e.g., IT Quality and Compliance) in the Pharmaceutical Industry.
    • Strong understanding of global regulations and Health Authorities’ expectations (CSV, Part 11).
    • Extensive experience in the development, implementation, and lifecycle management of computerized systems in regulated environments.
    • Experience in quality management of Cloud, SaaS platforms, mobile, and digital applications in regulated environments.
    • Expertise in managing operational GxP solutions and related technologies.
    • Knowledge of industry best practices (e.g., ITIL, ITSM).
    • Experience with key computerized systems in Pharmaceutical Development, Manufacturing, Quality, Commercial, and Infrastructure areas (e.g., ERP/SAP, MES, LIMS, CRM, IAM).
    • Proven success in cross-functional and international team collaborations.
    • Experience in GxP supplier qualification activities.
    • Strong ability to manage shifting priorities and demands while maintaining a positive attitude.
    • Effective communication and interpersonal skills for presenting to management and managing key stakeholders.

    Core Competencies:

    • Ability to influence stakeholders without hierarchical authority.
    • Proactive self-starter with proven experience in initiating and delivering projects and processes.
    • Excellent communication, negotiation, and facilitation skills.
    • Ability to build trust and manage relationships with key stakeholders.

    Commitment to Diversity and Inclusion:

    Novartis is dedicated to building an inclusive work environment with diverse teams that represent the patients and communities we serve.

    Accessibility and Accommodation:

    Novartis offers reasonable accommodations to individuals with disabilities. If you require accommodation for any part of the recruitment process or job functions, please email diversityandincl.india@novartis.com with your request and contact details.

    Why Novartis:

    Novartis is committed to making a difference in the lives of patients. By working together in a supportive and collaborative environment, we drive innovation and breakthroughs that transform patients' lives. Join us in shaping a brighter future.

    Join the Novartis Network:

    Not the right role for you? Sign up for our talent community to stay connected and explore future opportunities: Novartis Talent Network

    Benefits and Rewards:

    Explore the comprehensive benefits and rewards we offer to support your personal and professional growth: Novartis Benefits & Rewards

    Job Details:

    • Division: Operations
    • Business Unit: Innovative Medicines
    • Location: Hyderabad, India
    • Company/Legal Entity: Novartis Healthcare Private Limited
    • Functional Area: Quality
    • Job Type: Full-time
    • Employment Type: Regular
    • Shift Work: No

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