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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance - CSV – MES - Senior
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As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Manager actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you will consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.
The Opportunity
We are seeking an experienced Validation Consultant – Computerized System Validation (CSV) to lead validation and compliance for defining and executing the validation strategy for Manufacturing Execution System (MES) deployments using PAS‑X across regulated and business critical computerized systems for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence.
Your Key Responsibilities
- Validation Strategy & Planning: Develop the end‑to‑end validation approach for PAS‑X implementations, including CSV/CSA strategy, risk assessments, and the validation master plan or equivalent documents aligned to corporate QMS and current GxP expectations. Define scope, deliverables, and acceptance criteria for releases and site deployments.
- Regulatory Compliance: Ensure alignment with 21 CFR Part 11, EU Annex 11, Annex 15, ICH Q9/Q10, data integrity principles (ALCOA+), and applicable regional guidance. Monitor regulatory changes and translate them into pragmatic updates to validation practices.
- Lifecycle Documentation: Own and author or oversee key lifecycle documents: User Requirements (URS), Functional/Design Specifications (FS/DS), Configuration Specifications, Risk Assessments (FMEA/HAZOP where applicable), IQ/OQ/PQ protocols and reports, Traceability Matrices, Data Migration and Interface Validation, and periodic review plans.
- Test Governance & Execution: Define test strategy and environments for PAS‑X core, master batch record (MBR) configurations, interfaces (e.g., ERP, LIMS, historians, shop‑floor devices), and reports. Coordinate and witness test execution, deviations management, defect triage, and formal release decisions.
- Supplier & System Management: Lead quality oversight of the PAS‑X vendor and implementation partners per supplier qualification processes. Review vendor documentation, leverage vendor testing where appropriate under a risk‑based model and ensure adequate evidence for audits and inspections.
- Data Integrity & Security Controls: Validate user management, electronic records/signatures, audit trails, backup/restore, time synchronization, and segregation of duties. Confirm controls for recipe/MBR versioning, electronic batch record (eBR) review, exception handling, and e‑signature workflows.
- MBR/Content Validation: Establish standards and procedures for validating MBRs, libraries, and parameter sets. Ensure design reviews, simulation runs, and test data reflect representative production scenarios and critical process parameters.
- Infrastructure & Platform Qualification: Coordinate qualification of underlying infrastructure (on‑prem or cloud), databases, and PAS‑X application tiers following ITIL/DevOps and GAMP 5 guidance. Oversee change control for configuration items, patches, and upgrades.
- Interfaces & Automation: Drive validation of integrations with ERP (SAP/Oracle), LIMS, warehouse/dispensing, labeling, serialisation, SCADA/PLC, and historians using standardized patterns, message catalogs, and error‑handling tests.
- Change & Release Management: Implement compliant change control, versioning, and release procedures for PAS‑X and content. Chair or contribute to CABs, assess impact, and ensure regression testing and re‑validation are commensurate with risk.
- Audit/Inspection Readiness: Prepare teams and documentation for internal audits and health authority inspections. Lead responses to observations and CAPAs, and drive continuous improvement in validation processes.
- Cross‑Functional Leadership: Collaborate closely with Manufacturing, QA, QC, IT/OT, Engineering, Digital, and Site/Global Program teams. Provide coaching on CSV/CSA principles and mentor validation engineers and testers.
Qualifications
- Bachelor’s or Master’s degree in Biotechnology, , Engineering, or related field.
- 5+ years in Computerized System Validation (CSV/CSA) within GMP environments, with focused on MES; direct experience with Werum PAS‑X is strongly preferred.
- Hands‑on experience validating integrations with ERP, LIMS, SCADA/PLC, historians, and shop‑floor equipment; familiarity with ISA‑95/ISA‑88.
- 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.
Must-Have Skills & Attributes
- Deep understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, Annex 15, data integrity, ICH Q9/Q10, and relevant regional guidance.
- Strong Expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans. Familiarity with CSA principles and risk‑based testing.
- Experience working in Agile delivery models
- Understanding of PAS X architecture, modules (eBR, MBR design, Weigh & Dispense, Track & Trace, KPI/Reporting), and configuration lifecycle.
- Competence in test management tools, e.g., ALM/Jira/Xray, and document management in eQMS.
- Knowledge of databases, networking, virtualization/cloud (e.g., AWS/Azure), and cybersecurity controls as relevant to MES.
- Strong stakeholder management and client facing skills, with ability to collaborate across business, IT and quality teams
- Strong project management, problem solving and communication skills
Good-to-Have Skills & Attributes
- Exposure to business development activities and client engagement strategies.
- Awareness of AI/ML use in regulated environments and associated quality/governance considerations.
- Ability to align technology with business transformation goals.
- High attention to detail and analytical thinking.
- Familiarity with emerging regulatory trends, such as CSA or digital validation approaches.
- Adaptability to changing regulatory and business environments.
Preferred Certifications
- Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
- ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA).
- PAS‑X vendor training/certification or equivalent MES credentials
- Information Security or Risk Management certifications.
What we look for
- A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
- An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
- Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
What working at EY offers
At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:
- 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
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