About the role
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 knowledgeAplyr'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.
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 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.
