Manager, Quality Control, Lab Automation Enablement & Integration

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, 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.,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.

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

Bachelor's Degree

May involve access to U.S. export control laws (EAR). Employment contingent upon ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible. Moderna is unable to sponsor non-U.S. persons for an export control license.