Job Description Summary
Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations. Responsible for operational eCompliance support for Biomedical Research, ensuring compliance, validation oversight, and inspection readiness for GxP and non-GxP systems and associated supplier activities.
Job Description
Key Responsibilities
Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems
Manage and Support quality aspects of projects and activities, including those related to third parties, analytical instruments, manufacturing equipment, quality plans, training, IT validations, etc.
Provide operational eCompliance support for ~20 active systems (GxP and non-GxP), including Periodic Review, review of validation and change control deliverables, HLCCD review and sign-off
Support operational aspects of new system implementations, ensuring adherence to compliance and validation requirements
Perform technical aspects of IT / Technology Vendor Qualification and assessments
Provide inspection support for systems supported by the eCompliance manager
Provide input on technical aspects of SOPs, guidance, standards, and health authority (HA) regulation gap assessments
Support operational aspects of CAPAs and remediation activities, including review of CAPA documentation
Minimum Requirement
- Bachelor’s degree with ~5 years of experience or Master’s degree with ~2 years of experience in quality, compliance, or clinical development.
- Strong experience in audit & inspection management, quality management systems (QMS), quality assurance, and regulatory compliance across drug development.
- Proven expertise in SOP management and working within GxP-regulated environments (GCP, GLP, GMP).
- Solid understanding of computer system validation (CSV), change control processes, and IT supplier qualification and audits.
- Demonstrated experience supporting inspection readiness with strong attention to detail and regulatory alignment.
Skills Desired
Business Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledgeNovartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
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Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
