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EY

Senior Quality Consultant – Regulatory Compliance, SAP

EY

Senior Quality Consultant for SAP S/4HANA Quality Assurance at EY. Supporting clients in regulated compliance and quality assurance activities aligned with regulatory requirements.

Posted 5/8/2026full-timeHyderabad • 🇮🇳 IndiaSeniorWebsite

About the role

Key responsibilities & impact
  • Support Quality Assurance and compliance activities for SAP S/4HANA implementations in regulated (GxP) environments
  • Ensure alignment of SAP S/4HANA solutions with regulatory requirements (21 CFR Part 11, Annex 11, EU GMP, ICH, ISO)
  • Review and support validation deliverables including impact assessments, risk assessments, validation strategies, test documentation, and traceability
  • Support CSV / CSA activities for SAP S/4HANA, including system categorization, risk‑based validation approaches, and compliance documentation
  • Participate in quality governance and oversight, ensuring adherence to regulatory requirements and client quality standards
  • Support audit and inspection readiness, including preparation, evidence collation, and CAPA tracking related to SAP systems
  • Collaborate with Business, IT, QA, and SAP functional teams to ensure compliant and efficient solution delivery
  • Prepare, review, and approve quality and validation documentation such as SOPs, validation plans, test protocols, RTMs, and reports
  • Identify and proactively escalate quality, compliance, and delivery risks to project and EY leadership
  • Coach and guide project teams on SAP validation best practices, documentation standards, and regulatory expectations.

Requirements

What you’ll need
  • Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field.
  • 5+ years of experience in Quality Assurance, Validation, Regulated Compliance or GxP environments within pharmaceutical, life sciences or consulting organizations
  • Hands‑on experience supporting SAP implementations, preferably SAP S/4HANA, in regulated environments
  • Strong understanding of Quality Management Systems (QMS) and core quality processes (Deviation, CAPA, Change Control, Document Management, Training)
  • Strong understanding of global regulatory requirements including, ICH and ISO Guidelines, 21 CFR Part 11, Annex 11, EU GMP
  • Consulting or client‑facing experience preferred.
  • Excellent communication, documentation, and stakeholder management 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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
SAP S/4HANAQuality AssuranceValidationCSVCSARisk AssessmentTest DocumentationValidation StrategiesQuality Management SystemsRegulatory Compliance
Soft Skills
CommunicationDocumentationStakeholder ManagementCoachingCollaborationProblem SolvingLeadershipQuality GovernanceInspection ReadinessProactive Risk Identification