Manager, Quality Control, Lab Automation Enablement & Integration

Moderna • Norwood, MA

1d • Onsite

About The Position

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. Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide. As Manager, Quality Control – Automation & Digital Enablement, you will lead the execution and scaling of QC laboratory automation initiatives aligned to Moderna’s global QC digital and automation roadmap. Operating as a highly strategic individual contributor, you will translate complex analytical and business requirements into robust, compliant, and future-ready automated laboratory ecosystems. You will sit at the intersection of QC operations, digital enablement, and GMP governance—ensuring that robotics, liquid handling platforms, integrated digital workflows, and laboratory systems drive measurable performance, inspection readiness, and scalable impact across the Norwood site.

Requirements

• BS (minimum) in a scientific or engineering discipline; MS preferred.
• 5-8 years of experience in the pharmaceutical/biotech industry.

Nice To Haves

• Strong understanding of cGMP, regulatory requirements, and industry standards.
• Strong laboratory automation background, including experience with automated liquid handling and integrated lab systems
• Prior experience working in QC or other regulated analytical testing laboratories strongly preferred.
• Demonstrated success leading complex, cross-functional projects in a GMP environment
• Experience managing or mentoring technical teams
• Detail-oriented, organized, and capable of managing multiple projects in a fast-paced environment.
• Strong project management skills, including planning, risk management, and stakeholder communication.
• Exceptional written and verbal communication skills, with the ability to:
• Build clear, concise executive-level presentations
• Present confidently to senior leadership and VP audiences
• Comfortable operating in a fast-paced, matrixed organization with competing priorities.

Responsibilities

• Lead the execution of QC laboratory automation initiatives aligned with the global QC digital and automation roadmap.
• Translate business needs into executable automation strategies, detailed project plans, and clearly prioritized workstreams.
• Partner with system owners (e.g., LIMS, CDS, robotics platforms) to ensure automation solutions integrate seamlessly into QC workflows and digital laboratory infrastructure.
• Own end-to-end delivery of QC automation projects, including scope definition, timeline development, resourcing plans, risk mitigation strategies, and stakeholder alignment.
• Drive governance forums by preparing high-quality slide decks, project summaries, and status updates for Steering Committees, Quarterly Business Reviews (QBRs), and VP-level reviews.
• Ensure projects are delivered on time, within scope, and in full compliance with GMP and data integrity requirements.
• Own and/or oversee quality system records related to automation initiatives, including change controls, deviations, CAPAs, and impact assessments as applicable.
• Ensure automation solutions meet cGMP, ALCOA+, data integrity, and regulatory expectations across their full lifecycle.
• Serve as a QC automation Subject Matter Expert (SME) during regulatory inspections and audits.
• Provide technical leadership and rigorous review for automated laboratory systems, including liquid handlers (e.g., Hamilton, Andrew+), robotic platforms, and integrated digital workflows.
• Establish, implement, and maintain SOPs, work instructions, and governance processes for automated methods and systems.
• Monitor automation performance metrics and drive continuous improvement based on system reliability, operational efficiency gains, and measurable business impact.
• Collaborate cross-functionally with QC, Digital/IT, QA, AS&T, Analytical Development, and Applied Technologies to align QC priorities with broader business objectives.
• Identify and advance opportunities to embed advanced digital capabilities—including data analytics and emerging Generative AI-enabled tools—to optimize QC workflows, enhance insight generation, and strengthen decision-making within GMP frameworks.

Benefits

• Best-in-class healthcare coverage, 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 planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

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