Leads CQV and Compliance Engineering within Takeda’s GCC, overseeing qualification strategies, validation frameworks, GMP compliance, risk-based methodologies, governance, inspection readiness, and digital qualification approaches. Develops engineering capabilities, coaches technical teams, manages resources, and drives standardization and continuous improvement across capital projects and regulated facilities.
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Job DescriptionOBJECTIVES/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.
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