R&D Quality CMC Lead - (US)

Role Summary

R&D Quality CMC Lead is the strategic and technical quality leader across the CMC development lifecycle, from early clinical development through PPQ and launch, across all modalities (Small Molecules, Biologics, Plasma-Derived Therapies, Vaccines) and all Therapeutic Areas Units. Ensure quality excellence and lifecycle continuity by aligning CMC quality oversight across modalities and global regions. Drive cross-functional alignment with R&D, Regulatory CMC, and Commercial Quality to enable smooth late-stage transitions to commercialization. Location: Lexington, MA.

Responsibilities

• Provide strategic and technical direction for CMC quality activities across the early clinical development through PPQ for all modalities, ensuring differentiated and phase-appropriate approaches.
• Lead alignment on quality systems, policies, and procedures across clinical development phases and product lifecycle stages.
• Represent R&D GMP Quality in cross-functional forums including Global CMC, Regulatory, and Commercial Quality Operational Units to ensure regulatory and inspection readiness.
• Guide and support critical manufacturing and laboratory investigations, PPQ strategy development, and regulatory interactions.
• Monitor evolving regulatory requirements and quality trends across modalities to ensure 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 recurring leadership forums 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.

Qualifications

• 10+ years of pharmaceutical industry experience with a focus on Quality and CMC development.
• Required: Demonstrated hands-on technical and strategic experience with Small Molecule and Biologics programs.
• Preferred: Experience supporting PDT and Vaccines programs.
• Strong background in regulatory inspections (e.g., FDA, EMA) and submission support (IND, NDA, BLA).
• Experience with quality system development and lifecycle management principles across diverse product modalities.

Education

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

Skills

• Strategic 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: strategic enterprise thinking, inspires and enables people, focuses on high-impact priorities, and elevates capabilities
• Innovation: drives quality strategies and digital tools to enhance lifecycle oversight and inspection readiness
• Complexity: operates globally across modalities and functions, managing multiple late-stage assets concurrently
• Interaction: regular engagement with senior stakeholders across R&D, Regulatory CMC, Commercial Quality, and external partners
• Decision-making and Autonomy: leads decision-making on CMC Quality strategies for late-stage assets, balancing risk and regulatory requirements in time-sensitive, cross-functional contexts