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.

Responsibilities

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

Requirements

Bachelor's Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience; 3 – 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices; Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations; Fluency in French and English as working language; Demonstrated ability and willingness to work across rotating shifts, including morning, afternoon and night shifts

Benefits

Competitive healthcare; voluntary benefit programs; 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 discretionary year-end shutdown; savings and investments; location-specific perks and extras; annual discretionary bonus; other incentive compensation; equity award