Lead CQV Compliance

IND - 2028 Takeda Innovations India Private Limited; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Takeda Bengaluru seeks an experienced CQV & Compliance Engineering leader to drive qualification strategies, validation frameworks, and lifecycle quality practices across GMP and regulatory programs.

You will build capabilities, mentor engineers, and partner with Quality, Manufacturing, and Digital teams to ensure inspection readiness and continuous improvement.

Qualifications

• Experience 10+ years in CQV, Validation, Quality Engineering, Compliance or related disciplines.
• Experience supporting GMP-regulated facilities and capital projects.
• Experience developing qualification frameworks, plans, and standards.

Responsibilities

• Lead, coach, and develop CQV & Compliance Engineers; manage capacity, priorities and resources.
• Provide expertise for qualification strategies, validation frameworks, and compliance methodologies; support readiness reviews.
• Ensure GMP, Data Integrity and regulatory compliance; lead governance activities, quality reviews, and inspections readiness.

Skills

Leadership

Stakeholder management

Strategic thinking

Quality mindset

Continuous improvement

Communication

Education

Bachelor's degree in Engineering/Life Sciences/Pharmaceutical Sciences/Quality

Master's degree preferred

Tools

KNEAT

Paperless validation systems

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 Drive standardization and reuse of qualification and compliance frameworks. Promote risk-based and digital qualification approaches. Support continuous improvement of qualification and compliance methodologies. Develop standards, templates, and best practices.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• Education Bachelor's Degree in Engineering, Life Sciences, Pharmaceutical Sciences, Quality, or related discipline. Master's Degree preferred.
• Experience 10+ years of experience in CQV, Validation, Quality Engineering, Compliance, or related disciplines. Experience supporting GMP-regulated facilities and capital projects. Experience developing qualification frameworks, plans, and standards. Experience leading technical teams and capability development initiatives.
• Behavioural Competencies Leadership and talent development. Stakeholder management and collaboration. Strategic thinking and decision making. Quality and compliance mindset. Continuous improvement mindset. Strong communication and influencing skills.
• Technical Skills Qualification Planning and Strategy. KNEAT and or other paperless validation system skills. ASTM E2500 and Risk-Based Qualification. Validation Framework Development. GMP Compliance. Data Integrity and Computerized Systems Compliance. GAMP5 and CFR Part 11. Inspection Readiness and Regulatory Expectations. Engineering Quality Systems.

Locations IND - Bengaluru

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people's lives - including your own.

Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please request a reasonable accommodation.