Lead CQV Compliance

takeda· IND - 2028 Takeda Innovations India Private Limited
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📍 IND - BengaluruFull time

About this role

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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

  • 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

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Frequently Asked Questions

Is the salary disclosed for the Lead CQV Compliance position at takeda?
The salary for this Lead CQV Compliance role at takeda is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Lead CQV Compliance position at takeda located?
This Lead CQV Compliance role at takeda is based in IND - Bengaluru. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Lead CQV Compliance role at takeda full-time or part-time?
This is listed as a Full time position. It is posted as a Lead CQV Compliance role in the IND - 2028 Takeda Innovations India Private Limited department at takeda.
Which team or department does the Lead CQV Compliance at takeda belong to?
This Lead CQV Compliance position is part of the IND - 2028 Takeda Innovations India Private Limited department at takeda. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Lead CQV Compliance position at takeda?
Click the "Apply Now" button on this page. You will be redirected to takeda's official application portal hosted on workday where you can submit your application directly.
When was the Lead CQV Compliance job at takeda posted?
This Lead CQV Compliance position at takeda was posted on Sep 29, 2026. Apply as soon as possible — early applications are often reviewed first.
Lead CQV Compliance
takeda
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