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Regulatory Compliance Manager – CSV QA
EYRegulatory Compliance Manager with ScrumMaster experience in GxP Validation for EY's Consulting team. Leading cross-functional projects to ensure compliance with regulations and enhancing client engagement.
Tech Stack
Tools & technologiesSDLCVault
About the role
Key responsibilities & impact- Lead validation activities for GxP and non GxP systems using a risk‑based approach aligned with GAMP 5 and SDLC principles
- Perform software classification, IT risk assessments, and define mitigation strategies
- Conduct gap assessments and remediation for legacy or non‑compliant systems
- Author and review core validation deliverables (URS, FRS, Validation Plans, IQ/OQ/PQ, Traceability Matrix, Final Reports)
- Maintain audit‑ready documentation and ensure end‑to‑end data integrity throughout the system lifecycle
- Act as SME during internal audits and regulatory inspections, driving CAPA implementation
- Support transformation initiatives involving enterprise systems (SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, RIMS)
- Lead data migration, integration, and system connectivity activities across validated platforms
- Evaluate and validate system changes through structured impact assessments
- Manage periodic reviews, revalidation, and system retirement activities
- Facilitate all Agile/Scrum ceremonies (daily stand‑ups, sprint planning, refinement, reviews, retrospectives)
- Coach and mentor teams on Agile principles, Scrum best practices, and self‑organization
- Develop validation and Agile delivery strategies aligned with client objectives and regulatory requirements
- Prepare project updates, leadership presentations, and status communications
Requirements
What you’ll need- Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Computer Science, Engineering, or a related technical field
- 8-12 years of experience in Computer System Validation (CSV), GxP system implementation, or regulated IT delivery within the pharmaceutical/life sciences industry
- Certified Scrum Master (CSM), SAFe Scrum Master, or equivalent Agile certification
- Strong understanding of GxP regulations, GAMP 5, 21 CFR Part 11, Annex 11, and data‑integrity principles
- Hands‑on experience with regulated platforms such as Veeva Vault, SAP, LIMS, MES, ELN, Documentum, TrackWise, or ValGenesis
- Proven experience working in Agile/Scrum environments and facilitating Scrum ceremonies
- Strong knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11) and data‑integrity principles
- Hands‑on understanding of GAMP 5 methodology and the full system development life cycle (SDLC)
- Proficiency in CSV documentation including URS, FRS, IQ/OQ/PQ, Traceability Matrix, and Validation Plans
- Experience in performing risk assessments, software classification, and impact assessments for IT/validated systems
- Ability to conduct gap analysis, remediation planning, and lifecycle management for legacy and regulated systems
- Audit readiness expertise with experience supporting regulatory inspections and managing CAPA responses
- Strong understanding of Agile metrics, backlog management, sprint execution, and cross‑functional collaboration
- Excellent written and verbal communication skills, with strong documentation and presentation capabilities
- Ability to troubleshoot system/application issues and coordinate resolution with SMEs.
- Proven ability to mentor junior staff and lead validation or Agile delivery teams
Benefits
Comp & perks- Support, coaching and feedback from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Computer System Validation (CSV)GxP system implementationrisk assessmentssoftware classificationAgile delivery strategiesvalidation documentationgap analysisdata migrationimpact assessmentslifecycle management
Soft Skills
leadershipmentoringcommunicationcollaborationcoachingpresentation skillstroubleshootingself-organizationcross-functional collaborationAgile principles
Certifications
Certified Scrum Master (CSM)SAFe Scrum MasterAgile certification