Job Description

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.

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 knowledge