About The Role
The Global Material Qualification & Sustainability Specialist will play a key role in establishing and scaling a sustainable materials-by-design capability within GMQ/MSAT. This position supports enterprise risk resilience while ensuring patient safety, product quality, regulatory compliance, and supply continuity across Takeda's global manufacturing network.
The role integrates sustainability and substances of concern (SoC) considerations into global material change governance and Material Qualification (MQ) processes, enabling consistent, risk-based, and CMC-aware decision-making. In partnership with cross-functional stakeholders, the Specialist will enhance material and supplier transparency, support proactive risk management, and advance digital solutions that improve efficiency, consistency, and knowledge sharing across the organization.
How You Will Contribute
- Develop and maintain sustainable materials and SoC standards, decision criteria, templates, and governance documentation aligned with GMQ/MQ and MSAT objectives.
- Support sustainability and SoC screening within the Material Change Management process, including workflow execution, risk assessment, escalation, and adoption across the network.
- Maintain a global Materials/SoC risk and readiness portfolio, tracking emerging risks, mitigation actions, and supplier-related impacts.
- Partner with Procurement and Supplier Management to establish supplier data requirements, traceability expectations, and data quality standards for priority materials.
- Support Supplier Notification of Change and Material Change Management activities related to sustainability- or SoC-driven changes, collaborating with subject matter experts to develop risk-based qualification strategies.
- Coordinate technical assessments related to sustainable material substitutions, including potential impacts to material qualification activities such as extractables and leachables, where applicable.
- Develop and enhance digital tools and reporting capabilities, including SharePoint and Power Platform solutions, dashboards, structured registers, intake workflows, and knowledge management resources.
- Support and promote a Sustainable Materials Community of Practice through training, knowledge sharing, case reviews, and continuous improvement initiatives.
- Prepare leadership-ready reports and portfolio updates that communicate progress, adoption, risks, key decisions, and recommendations.
What You Bring To Takeda
Education & Experience
- Bachelor's degree in Science, Engineering, Materials Science, Pharmaceutical Sciences, or a related technical discipline required.
- 10+ years of experience within commercial biopharmaceutical manufacturing, Quality, MSAT, Supplier Quality, Packaging, Technical Operations, or a related field.
- Strong understanding of pharmaceutical development, manufacturing operations, product quality, GMP requirements, and material governance processes.
- Experience leading cross-functional initiatives and driving implementation within a global, matrixed organization.
- Experience supporting material qualification, supplier change management, quality risk management, supplier transparency initiatives, or sustainability/SoC programs preferred.
Technical & Functional Skills
- Knowledge of materials used in biopharmaceutical manufacturing and packaging systems, including polymers, elastomers, resins, coatings, adhesives, inks, and single-use technologies.
- Ability to translate sustainability and SoC considerations into practical, risk-based recommendations that balance patient safety, product quality, supply continuity, regulatory requirements, cost, and operational feasibility.
- Strong technical writing skills with experience developing standards, procedures, playbooks, training materials, and governance documentation.
- Advanced proficiency with Microsoft tools, including Excel, SharePoint, Power Platform, dashboards, data visualization, structured trackers, and knowledge management solutions.
- Excellent communication and stakeholder management skills, with the ability to influence and collaborate effectively across GMQ/MSAT, Procurement, EHS, Packaging & Device, Quality, Regulatory, CMC, and site organizations.
Core Competencies
- Technical Expertise: Applies scientific, quality, and analytical knowledge to assess material-related risks and support sound, risk-based decisions.
- Leadership: Builds trust, influences without authority, and drives alignment across global cross-functional teams.
- Decision-Making: Balances sustainability objectives with patient safety, product quality, regulatory requirements, supply resilience, and business needs.
- Digital Mindset: Leverages data, automation, dashboards, and scalable digital solutions to improve visibility, consistency, and efficiency.
- Innovation & Continuous Improvement: Translates complex and evolving requirements into practical governance, repeatable processes, and sustainable solutions.
- Collaboration: Promotes knowledge sharing, supports site teams and SMEs, and fosters an inclusive, patient-focused culture focused on continuous learning and improvement.
More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
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.
Locations
USA - MA - Cambridge
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.