Director, R&d Quality Cmc Lead

**About the Role**:

- As the strategic R&D Quality CMC Lead (EU) across Takeda’s Chemistry, Manufacturing, and Controls (CMC) development lifecycle, you will drive end-to-end quality excellence and enable seamless transitions from early clinical phases to commercial launch for a diverse pipeline—including Small Molecules, Biologics, Plasma-Derived Therapies, and Vaccines. In this influential role, you’ll shape and align quality strategies globally, lead cross-functional collaboration, and ensure inspection readiness, all while fostering innovation, continuous improvement, and strong stakeholder partnerships in a dynamic, science-driven environment_._

**How you will contribute**:

- 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.

**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.

**What you bring to Takeda**:
**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