Specialist, Quality Assurance

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. At our Laval site, you'll play a critical role in ensuring the highest quality standards across GMP manufacturing operations, helping bring innovative mRNA medicines to patients worldwide. Working at the heart of manufacturing, you'll provide real-time quality oversight, partner closely with cross-functional teams, and help build a culture where quality, compliance, and continuous improvement drive every decision. This is an opportunity for a quality professional who thrives in a fast-paced manufacturing environment, enjoys making informed decisions in real time, and is excited to leverage digital technologies and emerging AI-enabled tools to continuously strengthen quality operations and operational excellence. Here’s What You’ll Be Doing: Providing real-time, on-the-floor Quality support to Manufacturing through direct observation of manufacturing activities and monitoring process operations for compliance with established specifications. Making timely quality decisions while escalating issues that may impact operations and proactively identifying risks and gaps within GMP processes and quality systems. Performing routine facility walkthroughs to verify suite readiness, GMP compliance, implementation of best practices and support troubleshooting activities. Ensuring adherence to cGMP requirements, Standard Operating Procedures (SOPs) and manufacturing documentation while partnering with Manufacturing and support teams to manage new deviation events and review minor manufacturing deviations. Practicing safe work habits while following Moderna's safety procedures and identifying opportunities to improve operational efficiency. Working effectively within a shift structure, making independent decisions while appropriately escalating critical issues. Coordinating and approving deviation records. Coordinating and approving minor change control records. Issuing laboratory notebooks and logbooks while maintaining inventory control. Managing document archival activities, ensuring complete traceability for archived and retrieved documentation. Supporting Material Release, Batch Record Review and Product Disposition activities while demonstrating the flexibility to directly perform these responsibilities when required. Monitoring quality system metrics and process performance indicators to ensure compliance and operational excellence. Serving as a role model for Quality Culture while collaborating effectively across cross-functional teams. Supporting training coordination, capability development and professional growth within the QA organization. Authoring, reviewing and approving quality documentation including SOPs, Work Instructions, Forms and Training Materials to ensure regulatory compliance and cGMP adherence. Championing continuous improvement initiatives through strengthened quality systems, streamlined business processes and an increasingly capable workforce. Following all applicable GxP regulations, internal policies, SOPs and work instructions to ensure consistent compliance. Maintaining Good Documentation Practices and Data Integrity standards to support business operations, regulatory inspections and audits. Completing all required training according to defined qualification and requalification schedules. Contributing to an inclusive, collaborative and innovative working environment. Supporting internal audits and regulatory inspections. Providing Quality oversight of the site's Contamination Control Strategy. Providing Quality oversight of the Environmental Monitoring Program for cleanrooms and utilities. Providing Quality oversight of the Facility Sanitization Program. The key Moderna Mindsets you'll need to succeed in the role: We behave like owners. The solutions we’re building go beyond any job description. We act with