Sr. Ecompliance Specialist

10-7 years

Not Disclosed

Hyderabad

10 March 4, 2025

Job Description

Job Type: Full Time Education: B.E./B.Tech/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here’s your refined job description:

Sr. eCompliance Specialist

Job ID: REQ-10035976
Location: Hyderabad, India
Category: Quality
Business Unit: Innovative Medicines
Job Type: Full-time, Regular
Company: Novartis Healthcare Private Limited

Role Summary:

The Sr. eCompliance Specialist provides Quality Assurance oversight and guidance for computerized systems validation (CSV) in compliance with GxP, 21 CFR Part 11, and Novartis global quality standards. This role ensures regulatory adherence in GxP projects, oversees operational compliance, and supports audits and supplier qualification activities.

Key Responsibilities:

Quality & Compliance Oversight:

Provide quality oversight for operational activities of GxP computerized systems (e.g., Changes, Periodic Reviews, Deviations).
Ensure compliance with Novartis and regulatory requirements for GxP computerized systems.
Serve as the point of contact for CSV-related matters and act as an interface between IT and Business for GxP compliance.
Review and approve project documentation to determine GxP applicability.
Establish trusted partnerships with IT functions to align business drivers with compliance needs.

Operational Support & Documentation:

Review and approve GxP changes and associated deliverables.
Ensure compliance with GxP deviation management and support CAPA implementation.
Support the preparation and execution of Validation Master Plans (VMP).
Review and approve Periodic Review Reports for GxP computerized systems and manage compliance gaps.
Conduct supplier qualification assessments and support audit activities.

Key Performance Indicators:

Timely review and approval of changes, deviations, and periodic review reports.
Up-to-date and audit-ready documentation supporting eCompliance and CSV requirements.
Proactive identification of compliance gaps and support in mitigation plan development.
Effective stakeholder engagement and collaboration across business units.

Qualifications & Experience:

Essential Requirements:

10-15 years of overall IT experience, with 7+ years in the pharmaceutical industry within IT Quality & Compliance.
Strong understanding of global regulations (CSV, 21 CFR Part 11, GxP).
Hands-on experience in the development, implementation, and lifecycle management of GxP computerized systems.
Experience in quality management for Cloud, SaaS, mobile, and digital applications in regulated environments.
Knowledge of system application management, ITIL, ITSM, ERP/SAP, MES, LIMS, CRM, IAM, etc.

Desirable Skills:

Experience in GxP supplier qualification.
Ability to manage cross-functional international teams and influence stakeholders.
Strong communication, negotiation, and leadership skills.
Proven ability to handle multiple priorities while maintaining a positive work attitude.

Commitment to Diversity & Inclusion:

Novartis is committed to fostering an inclusive work environment and providing reasonable accommodations for individuals with disabilities.

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Sr. Ecompliance Specialist

Job Description

Role Summary:

Key Responsibilities:

Quality & Compliance Oversight:

Operational Support & Documentation:

Key Performance Indicators:

Qualifications & Experience:

Essential Requirements:

Desirable Skills:

Commitment to Diversity & Inclusion:

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