Head Engineering Information, Compliance & CQV
Bengaluru, Karnataka Job ID R0189963 Category Manufacturing Engineering Subcategory Manufacturing & Supply Business Unit Global Manufacturing & Supply Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
