Lead CQV Compliance

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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

Worker Type

Worker Sub-Type

Time Type