Senior Ecompliance Manager

15-20 years

Not Disclosed

India

10 Nov. 27, 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

Senior eCompliance Manager

Location: India
Job ID: REQ-10029642
Company: Novartis Healthcare Private Limited
Functional Area: Quality
Job Type: Full-time

About the Role

The Senior eCompliance Manager is responsible for ensuring the implementation of Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure. This role provides oversight and guidance in the development and delivery of systems that meet GxP standards, with a focus on data integrity and technical controls within the IT landscape.

Key Responsibilities

Point of Contact & Leadership:
- Serve as the single point of contact for all CSV (Computerized System Validation) matters related to GxP systems.
- Act as the interface between IT and business units to promote a Quality Culture.
- Establish partnerships with IT functions to understand business drivers and impacts on the eComplianceteam.
System Validation & Risk Management:
- Review and approve CSV deliverables for all Global GxP systems, ensuring GxP applicability.
- Conduct High-Level Risk Assessments (HLRA) and approve standards and documents related to both GxP and non-GxP systems.
- Support the lifecycle of GxP computerized systems, including validation, change controls, and deviations management.
Data Integrity & Compliance:
- Ensure ongoing Data Integrity (DI) and proper technical controls in the IT systems landscape.
- Provide eCompliance support for Strategic Projects and assist in the development of standards for governing GxP computerized systems.
Collaboration & Reporting:
- Work closely with functional IT staff in the compliant development of systems.
- Support the measurement of Key Quality Indicators (KQIs) and execution of the Data Integrity (DI) Plan.

Essential Requirements

Experience:
- 15-20 years of overall experience, with at least 10 years in the pharmaceutical industry, specifically in regulated functions like IT Quality and Compliance.
- Profound understanding of global regulations and Health Authority expectations regarding computerized systems, including 21 CFR Part 11, CSV, and lifecycle management.
Skills & Expertise:
- Strong experience in the development and management of computerized systems in regulated environments (e.g., ERP, MES, LIMS, CRM).
- Extensive knowledge of quality management for Cloud, SaaS platforms, and mobile applications used in regulated environments.
- Ability to manage GxP solutions and technologies in cross-functional teams.
Leadership & Interpersonal:
- Ability to interact effectively with Management and health authority inspectors.
- Strong communication, negotiation, and facilitation skills.

Desirable Requirements

Education:
- Degree in Life Sciences, Pharmacy, Engineering, or Information Technology; advanced degree preferred.

Why Novartis?

Novartis is committed to improving lives through innovative science and fostering a collaborative, supportive environment to achieve breakthroughs in healthcare.

Benefits and Rewards

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

Join the Novartis Network

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

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Senior Ecompliance Manager

Job Description

Senior eCompliance Manager

About the Role

Key Responsibilities

Essential Requirements

Desirable Requirements

Why Novartis?

Benefits and Rewards

Join the Novartis Network

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