Sr. Manager, External Ds & Qc Operations (Granada)
hace 17 horas
Granada
ph3Job Overview /h3pJoining 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. This is an opportunity to lead external Drug Substance and Quality Control operations across a complex network of CMOs, CDMOs, and CTLs. /ph3Key Responsibilities /h3ulliLead and drive operational reviews with external partners across the assigned External Operations scope. /liliOwn external partner operational delivery, governance effectiveness, and performance management. /liliLead performance oversight, action tracking, follow‑up activities, and delivery execution across assigned partners. /liliLead business reviews, executive management reviews, and Quarterly Business Reviews (QBRs) as applicable. /liliEstablish and oversee issue management processes, escalation pathways, and decision‑making frameworks to ensure timely resolution of operational risks, issues, actions, and decisions. /liliDrive cross‑functional alignment across internal and external stakeholders, including MST, Quality, Supply Chain, Regulatory, Finance, Procurement, Legal, Technical Development, and external partners. /liliLead external partner relationship management and ensure strong collaboration across the manufacturing network. /liliDrive operating model execution and governance readiness across functions and partners. /liliSet direction for integrated planning activities and approve tracking against the Master Production Schedule (MPS), including production, release, disposition, and shipping activities as applicable. /liliCoordinate KPI reviews, identify performance gaps, and develop action plans that improve partner performance and delivery outcomes. /liliSupport preparation for and execution of CMC and SOP processes as applicable within the assigned scope. /liliIdentify, champion, and implement continuous improvement initiatives, digital enablement strategies, and innovative solutions that enhance operational visibility, governance, and execution. /liliLead Master Service Agreement (MSA) integrity by ensuring alignment with Quality Agreements and execution of applicable contractual obligations in partnership with relevant functions. /liliLead Scope of Work (SoW) governance, alignment activities, and ongoing updates. /liliOwn and oversee purchase order, forecast, invoice lifecycle management, and closeout activities for assigned external partners. /liliLead project management activities, including RAID (Risk, Assumption, Issue, Decision) governance, milestone planning, reporting, and execution oversight. /liliLead technical transfer activities and product lifecycle initiatives including Technology Transfer (TT), New Product Introduction (NPI), Process Performance Qualification (PPQ), and related programs where applicable. /liliCoordinate, review, and approve GMP documentation packages including Batch Records (BR/MBR), deviations, change controls, and CAPAs within the assigned scope. /liliLead governance of Quality Management System (QMS) workflows, ensuring timely progression of deviations, change controls, CAPAs, and associated quality records. /liliEnsure assigned training and requalification requirements are executed and maintained in compliance with internal and regulatory expectations. /liliLead, coach, develop, and motivate direct reports while driving team objectives, performance management, talent development, succession planning, and an inclusive culture. /liliIdentify and assign appropriate deputies to support business continuity during periods of absence. /liliEnsure strict compliance with all applicable GxP regulations, guidelines, company policies, and integral regulatory requirements. /liliExecute responsibilities in accordance with standard operating procedures (SOPs), work instructions, and internal governing documents. /liliMaintain adherence to Good Documentation Practices and Data Integrity requirements, ensuring records, documentation, and data are complete, accurate, inspection‑ready, and available to support audits and regulatory inspections. /liliComplete all required training and maintain qualification status according to defined timelines and requalification requirements. /li /ulh3Basic Qualifications /h3ulliUniversity degree in an appropriate discipline (e.g., sciences, engineering, pharmacy, chemistry, biotechnology, supply chain, or business). /liliAdvanced degree (MS, Ph.D., MBA) and/or PMP is preferred, but not required. /lili10 years of experience or MS with at least 8 years of experience in a pharmaceutical or biotechnology company, preferably in external manufacturing, external operations, quality, supply chain, technical operations, project management, or a related GxP environment. /liliExperience working with CMO/CDMO partners, cross‑functional governance, operational and business reviews, KPI tracking, integrated plan governance, QMS workflows, GMP documentation packages, issue escalation, technical transfer, and product lifecycle execution is preferred. /liliDemonstrated ability to lead cross‑functional teams, influence across internal and external stakeholders, drive escalation pathways, and manage partner performance and delivery outcomes. /liliDemonstrated aptitude or ability to learn to gain a strong understanding of GxP and GMP regulations. /liliWorking proficiency in English is required. /li /ulh3Key Mindsets /h3ulliWe act with dynamic range, driving strategy and execution at the same time at every step. /liliWe digitize everywhere possible using the power of code to maximize our impact on patients. /li /ulh3Benefits /h3ulliBest‑in‑class healthcare, plus voluntary benefit programs to support your unique needs. /liliA holistic approach to well‑being with access to fitness, mindfulness, and mental health support. /liliFamily building benefits, including fertility, adoption, and surrogacy support. /liliGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown. /liliSavings and investments to help you plan for the future. /liliLocation‑specific perks and extras. /li /ulpModerna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. If you need assistance completing any part of the application process, please contact the Accommodations and Adjustments team at . /pp#J-*-Ljbffr /p /p #J-18808-Ljbffr