Jobs · Quality Assurance · Massachusetts

Sr Manager, Global Material Qualification & Sustainability

Takeda · Cambridge, MA · 4 days ago
Quality Assurance$137k–$215k/yrFull-time

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.

Responsibilities

  • 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.

Requirements

  • 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.

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.

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