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Job Description

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 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.

What we offer you:

A competitive remuneration package with a minimum salary of € 6.121,76 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary is higher and depends on your professional experience and qualifications.

• Family-friendly company environment; support with parental leave, dad month, Bilingual company kindergarten
• Company car or car allowance
• Short Term and Long Term Incentive Program 
• Comprehensive training programs
• In-house job rotation program
• In-house Canteen with discounts or meal vouchers
• Works council (events, festivals, shopping vouchers, etc.)
• Employee Referral Program
• Employee Recognition Program
• Takeda Resource Groups
• Medical checkups
• Free vaccination program
• Employee discounts 
• Employee Stock Purchase Plan
• Group accident insurance 

More About Us:

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 240 years of distinguished history in Japan.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Make History, Change Futures.

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, the organization spans the globe—colleagues across business units and functions face challenges head-on to deliver on our vision. The omnipresent patient focus instills pride in personal contributions.

How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process. 

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