External Supply Lead, Clinical Manufacture & Supply

AstraZeneca • Gaithersburg, MD

2d • Hybrid

About The Position

About the role AstraZeneca’s Pharmaceutical Technology & Development (PT&D) turns scientific concepts into medicines that help millions of patients. Within PT&D, our Clinical Manufacture & Supply (CM&S) organization provides an agile, end-to-end clinical supply chain—manufacturing, outsourcing, and delivering supplies to hundreds of thousands of patients globally. We are seeking an External Supply Lead to join our External Commercial Products team within the Oncology Therapy Area. In this role you will source commercially available medicinal products and related services to support AstraZeneca-sponsored clinical trials. You will build and manage strategic supplier relationships, design robust sourcing strategies, and ensure GDP/GMP-compliant, audit-ready supply chains that meet study timelines, quality, and cost targets. You’ll partner closely with Clinical Manufacturing & Supply (CM&S), Quality, Procurement, Clinical Operations, and Business Development stakeholders to deliver right-first-time supply.

Requirements

• Bachelor's Degree in a relevant discipline (Life Sciences, Supply Chain, Pharmacy, Business, or related field).
• Minimum 5+ years of experience in clinical trial supply, pharmaceutical procurement, or comparator sourcing, including third party and supplier relationship management.
• Demonstrated project management and change management skills with ability to balance multiple competing priorities and deliver to timelines.
• Appropriate technical depth in Clinical Trial Supply to evaluate risks (availability, shelf-life, stability, labelling, documentation) and make evidence-based decisions with technical/quality experts.
• Strong understanding of quality principles and cGMP/GDP, including documentation and audit readiness.
• Proven negotiating and problem-solving skills; strong influencing and communication skills with cross-functional, multicultural teams.
• Digital aptitude; ability to work within multiple systems; SAP experience preferred.
• Commitment to sustainability and ethical sourcing practices; experience with master data governance.

Nice To Haves

• Master's Degree in a relevant discipline (Life Sciences, Supply Chain, Pharmacy, Business, or related field).
• Prior experience in pharmaceutical sponsor, CDMO/CRO, or specialty distributor environment.
• Familiarity with RFI/RFQ processes, cost modelling, and comparator market dynamics.
• Lean/continuous improvement expertise and business process management experience.

Responsibilities

• Strategic Sourcing and Supply Design: Develop and execute sourcing strategies for commercially available products used in clinical trials, aligning to protocol needs, global market availability, shelf-life, and regulatory requirements. Leverage direct-from-manufacturer and qualified wholesale routes to ensure supply resilience and full traceability.
• Supplier Management and Negotiation: Identify, evaluate, qualify, and manage third-party suppliers. Negotiate pricing, lead times, and documentation packages to optimize total value while meeting trial requirements. Drive supplier performance through regular business and quality reviews.
• Compliance and Quality: Ensure sourcing and logistics are GDP/GMP compliant and audit-ready. Partner with Quality Assurance on supplier qualification, Technical/Quality Agreements, temperature-control requirements, serialization/traceability, and counterfeit-risk mitigation.
• Project and Stakeholder Leadership: Serve as the sourcing point of contact for assigned products. Anticipate risk, manage change, and maintain clear communication of milestones and dependencies to meet start-up and supply timelines.
• Market Intelligence and RFP/RFQ: Conduct structured market research across geographies to identify optimal sourcing routes. Lead or support RFIs/RFQs, evaluate proposals, and recommend routes based on availability, compliance, cost, sustainability, and delivery risk.
• Quotation and Handover: Develop accurate, executable price scenarios and sourcing plans with verified product details. Maintain document retention per SOPs.
• Financial Delivery: Contribute to revenue/margin targets for externally sourced commercial products within CM&S. Maintain accurate pipeline and forecast inputs (close dates, probabilities, lead times) and provide sourcing data for management reporting.
• Continuous Improvement and Digital: Champion Lean and continuous improvement in sourcing processes, documentation, and supplier management. Use AZ systems (e.g., SAP) and digital tools to govern master data, track orders, and enhance visibility.
• External Engagement: Represent AstraZeneca in supplier meetings, audits (as required), and industry forums. Support development of value propositions and materials that communicate AZ’s comparator sourcing capabilities to internal stakeholders.

Benefits

• Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level