Practice Leader – GxP Compliance & Validation

Location: Hyderabad or Bangalore

Experience: 12+ years

Industry: Pharma / Biotech / Medical Devices / Healthcare

Role Summary

Lead and grow the GxP Compliance & Validation practice, combining regulatory consulting, solution leadership, business development and delivery governance.

Key Responsibilities

- Lead and expand the GxP Compliance & Validation practice and build high-performing teams.
- Drive consulting solutions across CSV, CSA, Data Integrity, QMS and FDA 21 CFR Part 11.
- Lead GxP assessments, validation strategies, remediation and inspection-readiness initiatives.
- Provide advisory on GxP IT applications, SaaS/Cloud and digital quality systems.
- Develop solutions, proposals, methodologies and go-to-market offerings.
- Drive business development, client relationships, revenue and practice growth.




- Govern strategic client engagements, ensuring quality, compliance, timelines and delivery outcomes.

Must-Have Experience

- 12+ years in Life Sciences consulting, GxP compliance, CSV/CSA or validation.
- Solid hands-on knowledge of CSV/CSA, Data Integrity, QMS and 21 CFR Part 11.
- Knowledge of GAMP 5, EU Annex 11 and risk-based validation.
- Proven practice leadership, business development and client-facing consulting experience.
- Strong leadership, communication and stakeholder management skills.
- Experience across Pharma, Biotech, Medical Devices or Healthcare.

Education: Bachelor’s/Master’s in Life Sciences, Pharmacy, Engineering, IT, Computer Science or related discipline.

📌 Practice Leader – GxP Compliance & Validation (Hyderabad)
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📍 Hyderabad