The pharmaceutical industry continues to evolve with advancements in technology and compliance, and Novartis, a global leader in healthcare innovation, invites you to join its dynamic team as a Senior eCompliance Specialist. This role is pivotal in ensuring Quality Assurance oversight for computerized systems validation (CSV) and adherence to regulatory frameworks like GxP and 21 CFR Part 11.
About Novartis
Novartis is a global healthcare company committed to improving and extending people’s lives. With cutting-edge research and innovative therapies, Novartis is a trusted partner for delivering quality healthcare solutions. Employees are at the forefront of its success, driving innovation while maintaining stringent compliance with global regulatory standards.
Key Responsibilities
As a Senior eCompliance Specialist, you will:
- Quality Oversight:
- Ensure compliance of GxP systems with Novartis and regulatory standards.
- Review and approve changes, deviations, and Periodic Review Reports for GxP computerized systems.
- Subject Matter Expertise:
- Act as a point of contact for CSV-related matters and promote a quality culture within IT and business teams.
- Provide guidance on computerized systems validation and ensure alignment with the Novartis Quality Manual.
- Documentation and Reporting:
- Review and approve GxP project documents, deviation reports, and CAPAs.
- Prepare Validation Master Plans (VMPs) and ensure timely execution.
- Supplier Qualification and Audit Support:
- Conduct supplier qualification assessments for GxP-related systems.
- Provide audit support and assist in developing CAPA mitigation plans.
- Collaboration:
- Partner with IT and business functions to understand drivers and provide operational support.
- Foster cross-functional collaboration to manage GxP solutions effectively.
Qualifications and Requirements
To excel in this role, candidates should possess:
- Experience:
- 5–10 years of experience in the pharmaceutical industry, with at least 4 years in IT Quality and Compliance roles.
- Strong knowledge of global regulations, including CSV and Part 11.
- Technical Expertise:
- Proven experience in developing and managing GxP-relevant computerized systems.
- Familiarity with IT frameworks such as ITIL and ITSM.
- Hands-on experience in supplier qualification and GxP solution management.
- Soft Skills:
- Excellent communication, facilitation, and interpersonal skills.
- Strong negotiation and presentation abilities.
- Ability to multitask and adapt to shifting priorities.
Skills Needed
- In-depth understanding of global regulatory expectations for computerized systems.
- Expertise in lifecycle management of computerized systems in regulated environments.
- Strong problem-solving and analytical skills.
- Collaborative mindset with the ability to influence cross-functional teams.
