EY is seeking a Senior Manager – Computerized System Validation (CSV) to lead validation activities for GxP-regulated computerized systems for global pharmaceutical clients. This role is crucial for ensuring compliance with regulatory standards such as FDA, EMA, and MHRA. You will drive strategic initiatives for business process transformation and operational excellence, while also leading and mentoring teams.

As a key member of the EY-ER – Regulatory Compliance team, you will understand client business needs and deliver solutions aligned with EY guidelines. You will establish and strengthen relationships, ensuring high-quality deliverables and proactive risk identification. Join us to build an exceptional career and contribute to a better working world.

Lead GxP validation, implementation, and ensure the quality and compliance of IT systems in highly regulated environments. Guide clients through complex validation initiatives, translating operational and compliance needs into robust, risk-based solutions. Oversee end-to-end validation activities, including planning, testing, documentation, and release, ensuring audit-readiness.

Key responsibilities include leading regulatory compliance engagements, managing financial aspects, and driving business development. You will also build strong internal and client relationships, propose innovative solutions, and contribute to practice development initiatives. Foster a culture of continuous improvement and thought leadership.

A Bachelor's degree in Electronics, Electronics & Telecommunications, Computer Science, or a Master's in Science (preferably Chemistry/Biochemistry) is required, along with 13-16 years of experience with Big 4 or multinational regulatory compliance/life sciences outsourcing firms.

Strong expertise is needed in Computerized System Validation concepts (GAMP 5), GxP regulations (USFDA 21 CFR Part 11, EU GMP Annex 11), and various global regulatory standards. Proficiency in enterprise IT applications common in the pharmaceutical industry is essential. You must also possess strong knowledge of Quality System Elements like Deviation, CAPA, and Change Controls, along with data integrity requirements and audit support experience. Excellent interpersonal, written, and presentation skills are a must.