Lead CQV Compliance

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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

• Bachelors Degree in Engineering Life Sciences Pharmaceutical Sciences Quality or related discipline.
• Masters 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.