Sr. Manager, External DS & QC Operations

If you’re interested in this role, please apply in English and include an English version of your Resume/CV.

 

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 support business continuity during periods of absence.
• Ensure strict compliance with all applicable GxP regulations, guidelines, company policies, and global regulatory requirements.
• Execute responsibilities in accordance with standard operating procedures (SOPs), work instructions, and internal governing documents.
• Maintain 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.
• Complete all required training and maintain qualification status according to defined timelines and requalification requirements.

The key Moderna Mindsets you’ll need to succeed in the role:

• We act with dynamic range, driving strategy and execution at the same time at every step.
• We digitize everywhere possible using the power of code to maximize our impact on patients.

Here’s What You’ll Need (Basic Qualifications) 

• Education: University degree in an appropriate discipline (e.g. sciences, engineering, pharmacy, chemistry, biotechnology, supply chain, or business). Advanced degree (MS, Ph.D., MBA) and/or PMP is preferred, but not required.
• Experience: 10 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.
• Experience 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.
• Demonstrated ability to lead cross-functional teams, influence across internal and external stakeholders, drive escalation pathways, and manage partner performance and delivery outcomes.
• Demonstrated aptitude or ability to learn to gain a strong understanding of GxP and GMP regulations.
• Working proficiency in English is required.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare, plus voluntary benefit programs to support your unique needs

• A holistic approach to well-being with access to fitness, mindfulness, and mental health support

• Family building benefits, including fertility, adoption, and surrogacy support

• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown

• Savings and investments to help you plan for the future

• Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. 

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. 

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! 

Moderna 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. 

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. 

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