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Job DescriptionOBJECTIVES/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.
Skills Required
- Bachelor’s degree in engineering, quality, life sciences, information management, pharmaceutical sciences, or a related discipline
- Master’s degree
- 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
- Knowledge of GMP compliance and regulatory requirements
- Knowledge of ASTM E2500 and risk-based qualification principles
- Experience with validation and qualification frameworks, including Kneat or other paperless validation systems
- Knowledge of engineering information and document governance
- Knowledge of data integrity and lifecycle management
- Experience with engineering data management and reporting
- Knowledge of GAMP5 and computerized systems compliance
- Knowledge of digital information management and governance platforms
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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