Head Engineering Information, Compliance & CQV

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OBJECTIVES/PURPOSE

Lead the Engineering Information & Compliance function within the GCC and ensure the development of consistent compliant and high-quality engineering information qualification frameworks and compliance standards across the GCC-supported Global Design Engineering project portfolio.

Build and develop organizational capability technical expertise leadership pipelines and resource capacity across CQV & Compliance Engineering and Engineering Information Management.

Drive engineering excellence standardization compliance digitalization and continuous improvement through lifecycle-focused information and compliance management practices.

Ensure engineering deliverables qualification frameworks and engineering information support GMP quality regulatory data integrity and business requirements.

Accountabilities

Functional Leadership

• Lead and develop Engineering Information & Compliance teams and Design Leads.
• Establish workforce planning capability development succession planning and talent strategies.
• Support recruitment onboarding engagement and retention of engineering and compliance talent.
• Foster a culture of quality compliance collaboration innovation and continuous learning.

Engineering Information & Compliance Expertise

• Provide expertise for engineering information management qualification readiness validation frameworks and compliance methodologies.
• Establish and maintain standards templates procedures and best practices supporting engineering and qualification activities.
• Drive consistency of engineering information deliverables qualification documentation and compliance expectations across projects.
• Support lifecycle management of engineering data documentation and compliance artefacts.

Quality Compliance & Governance

• Ensure alignment with GMP requirements Data Integrity principles Takeda standards and applicable industry regulations.
• Ensure practices align with ASTM E2500 GAMP5 CFR Part 11 and applicable regulatory requirements.
• Oversee governance activities risk assessments audits lessons learned and inspection readiness support.
• Drive standardization and technical quality assurance of engineering and qualification deliverables across engineering deliverables and compliance frameworks.

Innovation & Continuous Improvement

• Promote digital information management and data-driven compliance practices.
• Drive standardization automation and reuse of templates procedures and engineering information.
• Support continuous improvement of lifecycle documentation qualification methodologies and engineering information quality.
• Identify opportunities to improve efficiency compliance traceability and engineering effectiveness.

Stakeholder Management

• Act as the primary GCC point of contact for Engineering Information and Compliance capabilities.
• Collaborate with Design Engineering Quality Manufacturing Project Teams Digital Manufacturing other Takeda Global functional groups and Site stakeholders.
• Support enterprise initiatives related to compliance readiness information governance and engineering excellence.
• Partner with projects and sites to ensure consistent application of engineering information and qualification standards.

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:

Education

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

Experience

• 15 years of experience in pharmaceutical engineering qualification validation compliance engineering information management or related disciplines.
• Experience supporting GMP-regulated facilities and capital projects.
• Experience leading multidisciplinary organizations and capability-building initiatives.
• Experience developing governance frameworks standards templates and lifecycle management processes.

Behavioral Competencies

• Strategic leadership and organizational development.
• People leadership and talent management.
• Stakeholder engagement and influencing skills.
• Quality and compliance mindset.
• Innovation and digital mindset.
• Continuous improvement mindset.
• Strong communication and decision-making capabilities.

Technical Skills

• GMP compliance and regulatory requirements.
• ASTM E2500 and risk-based qualification principles.
• Validation and qualification frameworks. Kneat and or other paperless validation systems.
• Engineering information and document governance.
• Data Integrity and lifecycle management.
• Engineering data management and reporting.
• GAMP5 and computerized systems compliance.
• Digital information management and governance platforms.