R&D Quality CMC Lead - (US)

Strategic And Technical Quality Leader

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

Decision-making And Autonomy

Interaction

Innovation

Complexity

Education, Behavioural Competencies And Skills :

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.

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

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.