About the role

Aplyr's Quick Take

The eCompliance Manager oversees quality assurance for computerized systems in a regulated pharmaceutical environment. This role involves approving changes, reviewing validation deliverables, and ensuring compliance with GxP regulations. It's primarily an individual contributor role focused on operational support and guidance.

Good fit

Ideal candidates have 8+ years in IT within the pharmaceutical industry, particularly in quality and compliance. A strong understanding of regulatory requirements and a collaborative working style will help you thrive here.

Worth noting

The role requires a deep understanding of both IT and regulatory compliance, which may be challenging for those without direct experience in GxP systems. The position also emphasizes building partnerships with IT and business teams, which could be a unique aspect for applicants.

Job Description Summary

The eCompliance Manager is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures.

eCompliance Manager provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations etc., Provides the guidance to the project and operations team on the CSV related topics and related information. Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects.

Job Description

Major Accountabilities:

Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,)
Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects.
Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.
Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems.
Establish trusted partnership with assigned IT Function with understanding of business drivers and provide the needed day to day operational support.
Review and approve the GxP Changes and the associated deliverables.
Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented.
Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions.
Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System.
Perform supplier qualification assessment activities.
Provide Audit support as assigned and in case of CAPAs, provide the required Quality support.

Essential requirements:

Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent.
8 years of IT experience with relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance.
Solid understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)
Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments.
Experience in quality management of Cloud, SaaS platform, mobile and digital application used in regulated environments.
Fluent in English

Skills Desired

Business Acumen, Communication Skills, Compliance Audits, Compliance Management, Compliance Risk Assesment, Compliance Training, Influencing Skills, Operational Excellence Projects, Quality Assurance

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.