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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.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Computer System Validation (CSV)GxP system implementationrisk assessmentssoftware classificationAgile delivery strategiesvalidation documentationgap analysisdata migrationimpact assessmentslifecycle management
Soft Skills
leadershipmentoringcommunicationcollaborationcoachingpresentation skillstroubleshootingself-organizationcross-functional collaborationAgile principles
Tools & Technologies
SAPLIMSELNMESDocumentumTrackWiseVeeva VaultValGenesisArgusRIMS
Certifications & Qualifications
Certified Scrum Master (CSM)SAFe Scrum MasterAgile certification
Industry Keywords
GxP regulationsGAMP 521 CFR Part 11Annex 11data integritypharmaceutical industrylife sciencesregulatory inspectionsCAPASDLC
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