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Job Description:

OBJECTIVES/PURPOSE:

• Lead the CQV & Compliance Engineering discipline within the GCC and provide expertise supporting qualification readiness, compliance frameworks, and lifecycle quality strategies.
• Build and develop CQV and Compliance Engineering capabilities, talent, technical expertise, and succession pipelines within the GCC.
• Drive consistent application of risk-based CQV methodologies, standardized deliverables, digital qualification approaches and lifecycle-focused compliance practices.
• Ensure engineering deliverables, qualification frameworks, and compliance processes support GMP, quality, regulatory, and business requirements.

Accountabilities:

Leadership:

• Lead, coach,



and develop CQV & Compliance Engineers.
• Support recruitment, onboarding, succession planning, and capability development.
• Manage discipline capacity, priorities, and resource allocation.

Qualification & Compliance Expertise:

• Provide expertise for qualification strategies, validation frameworks, and compliance methodologies.
• Support qualification readiness reviews and compliance assessments.
• Coordinate interfaces with Engineering, Quality, Manufacturing, Digital Manufacturing, and Project Teams.

Quality, Compliance & Governance:

• Ensure compliance with GMP requirements, Data Integrity principles, and Takeda standards.
• Ensure alignment with ASTM E2500, GAMP5, CFR Part 11, and applicable regulatory requirements.
• Lead discipline governance activities, risk assessments, quality reviews, and lessons learned.
• Support inspection readiness and compliance initiatives.

Innovation & Continuous Improvement:

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📌 Lead CQV Compliance (Bengaluru)
🏢 Takeda
📍 Bengaluru