Company
QualityManager(ecompliance)
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Manager (ecompliance). Skills: quality assurance expertise, operational eCompliance support, GxP regulations, audit & inspection management, quality management systems (QMS), quality assurance, regulatory compliance, SOP management, computer system validation (CSV), change control processes, IT supplier qualification and audits, inspection readiness. Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure com”
What You'll Achieve.
ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards; assure their compliance with GxP regulations; ensuring compliance, validation oversight, and inspection readiness for GxP and non-GxP systems and associated supplier activities; maintain or improve quality performance and compliance of operational activities; ensuring adherence to compliance and validation requirements
Industry & Context.
Problem Solving Skills
What They're Looking For.
Must Have
Bachelor's degree with ~5 years of experience or Master's degree with ~2 years of experience in quality, compliance, or clinical development., 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 attention to detail and regulatory alignment.
What You'll Do.
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.
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
and inspection readiness for GxP and non-GxP systems and associated supplier activities.
Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management
health authority reporting
Manage and Support quality aspects of projects and activities
including those related to third parties
analytical instruments
manufacturing equipment
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
and health authority (HA) regulation gap assessments
Support operational aspects of CAPAs and remediation activities
including review of CAPA documentation
How You'll Work.
Team & Collaboration
cross-functional coordination; vendor/stakeholder management
Communication Scope
Communication Skills
Process & Methodology
Manage projects, including Quality Plan initiatives, Manage and Support quality aspects of projects and activities
Full Job Description
**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 assur
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