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Senior Regulatory Compliance, CSV, Jama Connect System
EYValidation Consultant leading compliance and validation activities for global pharmaceutical clients at EY. Ensuring adherence to regulatory standards while driving strategic initiatives for operational excellence.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Computer System Validation (CSV) and compliance within GxP environments, with a strong focus on documentation and regulatory standards. Proficient in Agile methodologies and stakeholder management, ensuring quality and integrity throughout the validation lifecycle.
Highest-signal resume keywords
Computer System Validation (CSV)Jama ConnectRegulatory Compliance (GxP)Agile Delivery ModelsStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation Documentation (URS, FRS, IQ/OQ/PQ)Gap AnalysisRisk AssessmentsTraceability MatrixValidation Plans
Soft Skills
Excellent CommunicationProblem SolvingCoaching and Guiding Teams
Industry Keywords
GAMP 521 CFR Part 11Annex 11PharmaceuticalLife Sciences
About the role
Key responsibilities & impact- Support validation and compliance activities across GxP and non-GxP systems, aligning with global regulatory requirements and client objectives.
- Hands-on experience in validating Jama Connect and managing end-to-end requirements lifecycle, traceability, and CSV documentation (URS, FRS, Traceability Matrix) while ensuring adherence to GxP and regulatory compliance standards.
- Define and drive CSV/CSA strategies, enabling transition from traditional validation to risk-based assurance models.
- Integrate validation into Agile delivery models, ensuring compliance is embedded within iterative development cycles.
- Conduct impact assessments, gap assessments, and remediation for legacy and transforming systems.
- Author and review deliverables including URS, FRS, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, Traceability Matrix, and Summary Reports.
- Ensure data integrity and inspection readiness across systems.
- Coach and guide project teams on proper usage of templates, documentation expectations, and quality standards.
Requirements
What you’ll need- Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field
- 4-7 years in performing CSV activities within the pharmaceutical, life sciences or consulting organizations
- Strong understanding of regulatory requirements including, GAMP 5, 21 CFR Part 11, Annex 11
- Consulting or client‑facing experience preferred.
- Excellent communication, documentation, and stakeholder management skills.
- Hands-on experience with Jama Connect, including requirements management, traceability, and validation within regulated (GxP) environments.
- Strong Expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans.
- Experience working in Agile delivery models
- Understanding of AI/ML lifecycle, governance and validation skills
- Strong stakeholder management and client facing skills, with ability to collaborate across business, IT and quality teams
- Strong problem solving and communication skills.
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