Sr. Manager, External DS & QC Operations
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About the role
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. In Andalusia, Moderna partners with a local CMO in Granada to support active substance manufacturing for our mRNA medicines. The Granada team plays a key role in our global supply chain, helping deliver innovative solutions worldwide. We welcome professionals ready to advance biotechnology and make a meaningful impact on global health. This is an opportunity to lead external Drug Substance and Quality Control operations across a complex network of contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), and Contract Testing Laboratories (CTLs). You will serve as a strategic operational leader responsible for partner performance, governance, delivery execution, technical transfer activities, and lifecycle management while ensuring compliance with global regulatory expectations and cGMP requirements. Working across Manufacturing Science & Technology (MS&T), Quality, Supply Chain, Regulatory, Finance, Procurement, Legal, Technical Development, and external partners, you will drive operational excellence from production planning through release, disposition, shipping, and continuous improvement. This role offers significant exposure to digital transformation initiatives and opportunities to leverage advanced analytics and Generative AI-enabled approaches to enhance visibility, governance, decision-making, and operational performance. As a people leader, you will also build and develop a high-performing team, fostering an inclusive culture while driving talent development, succession planning, and business continuity. Here's What You'll Do: Lead and drive operational reviews with external partners across the assigned External Operations scope. Own external partner operational delivery, governance effectiveness, and performance management. Lead performance oversight, action tracking, follow-up activities, and delivery execution across assigned partners. Lead business reviews, executive management reviews, and Quarterly Business Reviews (QBRs) as applicable. Establish and oversee issue management processes, escalation pathways, and decision-making frameworks to ensure timely resolution of operational risks, issues, actions, and decisions. Drive cross-functional alignment across internal and external stakeholders, including MS&T, Quality, Supply Chain, Regulatory, Finance, Procurement, Legal, Technical Development, and external partners. Lead external partner relationship management and ensure strong collaboration across the manufacturing network. Drive operating model execution and governance readiness across functions and partners. Set direction for integrated planning activities and approve tracking against the Master Production Schedule (MPS), including production, release, disposition, and shipping activities as applicable. Coordinate KPI reviews, identify performance gaps, and develop action plans that improve partner performance and delivery outcomes. Support preparation for and execution of CMC and S&OP processes as applicable within the assigned scope. Identify, champion, and implement continuous improvement initiatives, digital enablement strategies, and innovative solutions that enhance operational visibility, governance, and execution. Lead Master Service Agreement (MSA) integrity by ensuring alignment with Quality Agreements and execution of applicable contractual obligations in partnership with relevant functions. Lead Scope of Work (SoW) governance, alignment activities, and ongoing updates. Own and oversee purchase order, forecast, invoice lifecycle management, and closeout activities for assigned external partners. Lead project management activities, including RAID (Risk, Assumption, Issue, Decision) governance, milestone planning, reporting, and execution oversight. Lead technical transfer activities and product lifecycle initiatives including Technology Transfer (TT), New Product Introduction (NPI), Process Performance Qualification (PPQ), and related programs where applicable. Coordinate, review, and approve GMP documentation packages including Batch Records (BR/MBR), deviations, change controls, and CAPAs within the assigned scope. Lead governance of Quality Management System (QMS) workflows, ensuring timely progression of deviations, change controls, CAPAs, and associated quality records. Ensure assigned training and requalification requirements are executed and maintained in compliance with internal and regulatory expectations. Lead, coach, develop, and motivate direct reports while driving team objectives, performance management, talent development, succession planning, and an inclusive culture. Identify and assign appropriate deputies to
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If you're interested in this role, please apply in English and include an English version of your Resume/CV.
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