Ecompliance Manager

10-15 years

Not Disclosed

Hyderabad

10 Jan. 15, 2025

Job Description

Job Type: Full Time Education: B.E./BCS 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 ID: REQ-10035974
Location: Hyderabad, Telangana, India
Posted on: January 8, 2025
Employment Type: Full-time, Regular

Role Summary:

The eCompliance Manager ensures Quality Assurance oversight and guidance for computerized systems validation (CSV) within GxP frameworks and regulatory requirements (e.g., 21CFR11). This role drives compliance, supports operational excellence, and fosters a culture of quality in managing GxP-relevant computerized systems.

Key Responsibilities:

Operational Quality Oversight:
- Ensure GxP systems' operational compliance with regulatory and Novartis standards.
- Approve changes, periodic review reports, and deviations related to GxP systems.
- Provide Quality Assurance guidance to teams on CSV-related topics.
Compliance and Documentation:
- Review and approve validation deliverables for GxP-relevant systems.
- Ensure timely and accurate documentation for audits and inspections.
Collaboration and Stakeholder Engagement:
- Act as the interface between IT and business for GxP computerized systems.
- Establish trusted partnerships with IT functions and stakeholders.
System and Vendor Management:
- Support system application management, including GxP supplier qualification.
- Oversee system lifecycle management for cloud, SaaS platforms, and digital applications.
Continuous Improvement and Risk Management:
- Identify and address gaps in eCompliance and CSV processes.
- Develop and implement mitigation plans for identified risks.
Audit and CAPA Support:
- Provide audit support and ensure CAPA implementation.
Project Contributions:
- Contribute to the development of Validation Master Plans (VMP) and related systems.

Essential Requirements:

Experience:
- 10–15 years of IT experience, with a minimum of 7 years in pharmaceutical and regulated environments.
- Strong background in CSV, regulatory compliance (e.g., 21 CFR Part 11), and lifecycle management of computerized systems.
Skills and Expertise:
- Solid understanding of global regulations and Health Authorities’ expectations.
- Proficiency in managing GxP solutions and technologies (ERP/SAP, MES, LIMS, CRM, etc.).
- Experience with system application management and industry best practices (ITIL, ITSM).
- Proven leadership in cross-functional international teams.
Interpersonal Skills:
- Strong negotiation, facilitation, and communication skills.
- Ability to influence without direct authority and build trusted relationships.
Problem-Solving and Adaptability:
- Proven ability to manage competing priorities and unexpected challenges while maintaining a positive attitude.

Why Novartis?

At Novartis, innovation meets collaboration. We strive to change patients’ lives by fostering a community of passionate, smart individuals working towards breakthroughs in healthcare.

Benefits and Rewards:
Explore comprehensive personal and professional benefits through our Life Handbook.

Diversity and Inclusion:
We are dedicated to building an inclusive and diverse work environment.

Accessibility:
If you require accommodations due to disability or medical conditions, email diversityandincl.india@novartis.com with the job requisition number and your contact information.

Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Location: Hyderabad, Telangana, India

Take the lead in ensuring quality and compliance in GxP computerized systems. Apply Now

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Ecompliance Manager

Job Description

eCompliance Manager

Role Summary:

Key Responsibilities:

Essential Requirements:

Why Novartis?

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