R&D Quality CMC Lead - (US)

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Job Description

• Serve as the strategic and technical quality leader across the Chemistry, Manufacturing, and Controls (CMC) development lifecycle, from early clinical development through process performance qualification (PPQ) and launch, ensuring phase-appropriate quality oversight tailored to all modalities (Small Molecules, Biologics, Plasma-Derived Therapies, Vaccines) and all Therapeutic Areas Unit (TAU).
• Ensure quality excellence and lifecycle continuity by aligning CMC quality oversight across all modalities and global regions — supporting Takeda’s accelerated R&D innovation and enabling smooth transitions from clinical development to commercial readiness.
• Drive cross-functional alignment between R&D, Regulatory CMC, and Commercial Quality to enable robust, efficient, and compliant transitions of late-stage assets to commercial readiness.
• Serve as the R&D GMP Quality focal point for programs, facilitating technical and  risk-based decision-making, supporting regulatory inspection readiness and fostering collaboration across internal and external stakeholders.
• Contribute to the implementation and evolution of the Quality Life Cycle Management process in alignment with Global SOPs and Takeda’s Product Operational Model.

ACCOUNTABILITIES 

• Provide strategic and technical direction for CMC quality activities across the early clinical development through process performance qualification (PPQ) for all modalities, ensuring differentiated and phase-appropriate approaches tailored to the needs of Small Molecules, Biologics, PDT and Vaccines.
• Lead alignment on quality systems, policies, and procedures across clinical development phases and product lifecycle stages, ensuring adaptability to diverse modality requirements.
• Represent R&D GMP Quality in cross-functional forums including Global CMC, Regulatory, and Commercial Quality Operational Units to ensure a unified approach to regulatory and inspection readiness.
• Guide and support critical manufacturing and laboratory investigations, PPQ strategy development, and regulatory interactions, ensuring a strong quality posture and inspection readiness.
• Monitor evolving regulatory requirements and quality trends across modalities to ensure R&D GMP Quality readiness and proactive compliance planning.
• Drive continuous improvement of Takeda’s CMC quality systems, SOPs, and tools
• Lead the Phase-Appropriate Community of Practice to align expectations and standards across development stages and modalities.
• Support knowledge transfer and alignment between R&D and Commercial Quality OpUs to reduce variability and post-market quality risks.
• Partner with key stakeholders in CSRB, CMC Strategy Review Boards, Pipeline Review discussions and Quality Matrix Meetings to ensure robust governance and escalation pathways.
• Lead the recurring leadership forum between R&D Quality and Commercial Quality with PQL, QA, QPs and OpU leaders to ensure strategic alignment, proactive risk management, and seamless quality execution across the development-to-launch continuum.

DIMENSIONS AND ASPECTS 

Technical/Functional (Line) Expertise

• Deep understanding of global CMC regulatory requirements, inspection trends, and industry best practices across all therapeutic modalities.
• Demonstrated technical experience and success supporting clinical-to-commercial transitions in Small Molecule and Biologics programs is required.
• Experience with Vaccines and Plasma-Derived Therapies is a strong plus.
• Proven experience managing complexity in global programs across multiple modalities and TAUs.

Leadership

• Strategic thinker with demonstrated ability to lead without direct authority and influence across matrixed organizations and modalities.
• Comfortable engaging and guiding senior leadership across R&D, Regulatory, and Commercial organizations.
• Creates an inclusive and collaborative environment that promotes innovation, accountability, and continuous learning.

Decision-making and Autonomy

• Leads decision-making on CMC Quality strategies for late-stage assets, aligned with Global Quality and business objectives.
• Balances risk and compliance in time-sensitive, cross-functional environments.

Interaction

• Regular interactions with senior stakeholders across R&D, Regulatory CMC, Commercial Quality, and external partners.
• Acts as primary Quality representative in enterprise-level CMC alignment and launch forums.

Innovation

• Drives innovation in quality strategies and digital tools to enhance lifecycle oversight, data transparency, and inspection readiness.
• Identifies and implements scalable solutions to meet evolving regulatory and business needs.

Complexity

• Operates globally across modalities and functions, supporting multiple late-stage assets concurrently.
• Requires strong judgment, regulatory understanding, and leadership in complex, high-stakes situations.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education / experience

·       Advanced degree in life sciences, pharmacy, chemistry, or related discipline preferred.

·       10+ years of pharmaceutical industry experience with a focus on Quality and CMC development.

·       Demonstrated hands-on technical and strategical experience with Small Molecule and Biologics programs is required.

·       Experience supporting PDT and Vaccines programs is strongly preferred.

·       Strong background in regulatory inspections (e.g., FDA, EMA) and submission support (e.g., IND, NDA, BLA).

·       Experience with quality system development and lifecycle management principles across diverse product modalities.

Core Competencies / Skills 

·     Strategic and critical thinking

·     Strong communication and influencing skills

·     Risk management and decision-making

·     Knowledge of GxP and global regulatory standards

·     Digital acumen and analytical capabilities

·     Collaboration across functions and geographies

·     Change leadership and cross-functional facilitation

Leadership Behaviors

·     Strategic enterprise thinking, creating innovative ways to serve patients and build trust.

·     Inspires and enables people to be their best.

·     Focuses on high-impact priorities and delivers superior results.

·     Elevates capabilities for today and the future.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$174,500.00 - $274,230.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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