Head Engineering Information, Compliance & CQV

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Job Description

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

Bachelor's Degree in Engineering, Quality, Life Sciences, Information Management, Pharmaceutical Sciences, or related discipline.

Master's 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.

Locations

IND - Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time