Specialist, Quality Assurance

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.

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…