EY GDS - Senior Manager - Regulatory Compliance - CSV/QA Lead

Role Overview:

As a Senior Manager - Computer System Validation (CSV), you will lead GxP validation, implementation, quality, and compliance of IT systems within highly regulated GxP environments. You will guide clients through complex validation initiatives while ensuring alignment with business and regulatory expectations.

Key Responsibilities:

- Participate and lead Regulatory Compliance engagements.

- Manage financial aspects of engagements including staffing and tracking fees.

- Drive business development initiatives and build internal/external relationships.

- Develop team competency through coaching, mentoring, and performance management.

- Lead practice development, workforce planning, and go-to-market strategies.

- Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, and Veeva Vault.

- Author and review validation deliverables such as Validation Plans, Risk Analysis, and Qualification Protocols.

Skills and Attributes:

- Consulting experience in the Life Sciences domain.

- Strong knowledge of GAMP 5, USFDA 21 CFR Part 11, and EU GMP Annex 11.

- Expertise in Enterprise IT applications like LIMS, SAP, and Veeva Vault.

- Understanding of Data Integrity, CAPA, and Change Control procedures.

Qualifications:

- MBA/B.E/B.Tech or Postgraduate in Science with 13 - 16 years of experience in Regulatory Compliance/Life Sciences outsourcing.

- Experience in managing teams and solution designing.