The Role Joining Moderna means advancing mRNA science to transform medicine. The role is pivotal in establishing a world‑class Quality Control organization supporting commercial manufacturing operations in Laval.

Key Responsibilities - Provide strategic and operational leadership for QC activities supporting commercial manufacturing, product lifecycle management, laboratory operations, and external partner oversight.

- Lead QC operations for raw material, in‑process, drug substance, drug product, microbiology, environmental monitoring, release testing, and stability testing.
- Oversee startup, qualification, and operational readiness of QC laboratories and implement laboratory systems, method transfers, qualification programs, validation activities, and compliant laboratory operations.
- Ensure delivery of compliant, reliable, and timely QC services across internal laboratories and external testing networks.
- Provide strategic oversight of environmental monitoring and critical utilities monitoring programs, ensuring contamination control, regulatory compliance, data trending, investigation management, and continuous improvement.
- Lead and support analytical method transfers, analytical qualifications, validations, and implementation of analytical changes for commercial products and new product introductions.
- Review and approve analytical methods, specifications, protocols, reports, stability documentation, and other cGMP records.
- Represent QC during regulatory inspections, health‑authority inspections, customer audits, vendor audits, and internal audits, maintaining a constant state of inspection readiness.
- Support technology transfers, process transfers, PPQ campaigns, and new product introductions.
- Partner with Digital and IT organizations to strengthen laboratory systems, automation strategies, data governance, and digital transformation initiatives.





Basic Qualifications - Bachelor’s degree in a relevant scientific discipline (Life Sciences, Biotechnology, Chemistry, Microbiology, Biochemistry, or related field); advanced degree preferred.

- Minimum of 10years of experience in QC within a commercial cGMP biotechnology or pharmaceutical environment, supporting both internal and external manufacturing and testing operations.
- Minimum of 4–6years of leadership experience, managing technical teams, laboratory operations, project management, and talent development.
- Strong working knowledge of global regulatory requirements and industry standards (FDA, Health Canada, EMA, ICH, ISPE, ASTM, GxP).
- Demonstrated experience in analytical testing, method transfer, method qualification, validation, and lifecycle management within the biotechnology or pharmaceutical industry.
- Proven expertise in Quality Systems, including deviations, OOS/OOT investigations, CAPAs, change controls, risk assessments, and data‑integrity programs.
- Position is site‑based with full‑time presence required at Moderna’s Laval site; remote work is not available.
- Minimum of 2years of work authorization required.

Preferred Qualifications - Solid knowledge and experience in environmental monitoring, contamination‑control strategies, and critical‑utilities monitoring programs within GMP‑regulated environments.

- Experience supporting regulatory inspections, health‑authority interactions, customer audits, vendor audits, and inspection readiness activities.
- Solid knowledge of laboratory operations supporting chemistry, microbiology, bioassays,



environmental monitoring, and stability programs.
- Experience managing QC activities at CMOs, CTLs, and external partners.
- Success leading complex analytical projects, investigations, process improvements, and cross‑functional initiatives in a fast‑paced environment.
- Strong technical writing and documentation skills, including review and approval of analytical methods, protocols, reports, specifications, and regulatory documentation.
- Proficiency with laboratory and enterprise systems (LIMS, SAP, LMS, electronic quality‑management systems, data‑analytics tools).
- Experience with laboratory instrumentation and software platforms, including chromatographic and analytical technologies.
- Excellent leadership, interpersonal, communication, and stakeholder‑management skills with the ability to influence across all organizational levels.
- Strong commitment to operational excellence, continuous improvement, innovation, and a culture of compliance, accountability, and teamwork.
- Fluent in English (written and oral); additional languages considered an asset.

Equal Employment Opportunity Moderna s’engage à offrir l’égalité d’accès à l’emploi et à ne pratiquer aucune discrimination envers ses employés ou les candidats qualifiés, sans égard à la race, à la couleur, au sexe, à l’identité ou l’expression de genre, à l’âge, à la religion, à l’origine nationale, à l’ascendance ou à la citoyenneté, à l’ethnie, à un handicap, à la situation militaire ou à un statut de vétéran protégé, aux informations génétiques, à l’orientation sexuelle, à l’état civil ou familial, ou à toute autre caractéristique personnelle protégée par la loi en vigueur. Nous étudions les candidatures qualifiées, peu importe les antécédents judiciaires, conformément aux exigences légales.

📌 Associate Director, Quality Control (Laval)
🏢 Moderna Therapeutics
📍 Laval