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.
As Moderna continues to expand its manufacturing capabilities in Canada, this role will play a pivotal leadership position in establishing and operating a world-class Quality Control organization supporting commercial manufacturing operations in Laval.
This individual will provide both strategic direction and hands-on operational leadership across analytical testing, microbiology, environmental monitoring, critical utilities monitoring, release testing, and stability programs while ensuring the highest standards of quality, compliance, and inspection readiness.
The successful candidate will lead the startup and operational readiness of Quality Control laboratories supporting drug substance and drug product testing, building robust laboratory systems, driving method transfers and validation activities, and creating sustainable testing operations capable of supporting Modernas expanding commercial manufacturing network and future product portfolio.
Working across internal and external networks, this leader will serve as a critical partner to Manufacturing, Analytical Science & Technology, Quality Assurance, Regulatory Affairs, Engineering, Supply Chain, Global Quality Control, Contract Manufacturing Organizations (CMOs), and Contract Testing Laboratories (CTLs).
This is a unique opportunity to help shape the future of Quality Control operations within a highly innovative manufacturing environment while leveraging advanced digital capabilities, laboratory automation, data analytics, and emerging AI-enabled technologies to enhance operational excellence, data integrity, and decision-making.
Here''s What You''ll Do: Provide strategic and operational leadership for Quality Control activities supporting commercial manufacturing, product lifecycle management, laboratory operations, and external partner oversight.
Lead the startup and operational readiness of Quality Control laboratories supporting drug substance and drug product testing, including laboratory systems implementation, method transfers, qualification activities, and compliant testing operations.
Oversee analytical testing, microbiology, environmental monitoring, critical utilities monitoring, release testing, and stability programs across internal laboratories and external networks.
Ensure the delivery of compliant, reliable, and timely Quality Control services while maintaining oversight of quality systems, investigations, data integrity, contamination control strategies, and continuous improvement initiatives.
Serve as the primary Quality Control representative and strategic partner to Manufacturing, Analytical Science & Technology, Quality Assurance, Regulatory Affairs, Engineering, Supply Chain, and Global Quality Control teams.
Provide strategic oversight of Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and other external testing partners to ensure quality, compliance, and operational excellence.
Lead analytical method transfers, qualifications, validations, and implementation of analytical changes supporting commercial products, new product introductions, and technology transfer activities.
Drive operational excellence through performance metrics, data analytics, laboratory automation, digital transformation initiatives, and opportunities to leverage advanced AI and Generative AI capabilities within Quality Control operations.
Lead complex technical investigations and ensure effective management of deviations, OOS/OOT investigations, CAPAs, change controls, and other quality system processes.
Support process validation, PPQ campaigns, regulatory submissions, Annual Product Quality Reviews (APQRs), and product lifecycle management activities.
Represent Quality Control during regulatory inspections, health authority interactions, customer audits, vendor audits, and internal audits while maintaining a continuous state of inspection readiness.
Build, develop, and lead high-performing Quality Control teams through coaching, mentoring, succession planning, performance management, and talent development.
Contribute to departmental strategy, resource planning, and budget management while fostering a culture of accountability, collaboration, innovation, and continuous improvement.
Act as a key liaison across local and global Quality organizations to support Modernas expanding commercial manufacturing network and future product portfolio The key Moderna Mindsets youll need to succeed in the role: We obsess over learning.
We dont have to be the smartest, we have to learn the fastest.
We digitize everywhere possible using the power of code to maximize our impact on patients.
Heres What Youll Need (Basic Qualifications) Bachelor''s degree in relevant scientific discipline (Life Sciences, Biotechnology, Chemistry, Microbiology, Biochemistry, or related field); advanced degree preferred.
The position requires proficiency in both French and English due to interactions with teams, partners, and tools located outside Quebec.
Minimum of 10 years of experience in Quality Control within a commercial cGMP biotechnology or pharmaceutical environment, including experience supporting both internal and external manufacturing and testing operations.
Minimum of 46 years of leadership experience, including management of technical teams, laboratory operations, project management, and talent development.
Strong working knowledge of global regulatory requirements and industry standards, including FDA, Health Canada, EMA, ICH, ISPE, ASTM, and applicable GxP regulations.
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.
This position is site-based, requiring you to be at Modernas site full-time.
This position is not eligible for remote work.
As part of Modernas commitment to build a sustainable workforce, a minimum of 2 years of work authorization is required for this role.
Heres What Youll Bring to the Table (Preferred Qualifications) Strong knowledge and experience in Environmental Monitoring, contamination control strategies, and Critical Utilities Monitoring programs within GMP-regulated biotechnology or pharmaceutical manufacturing environments, including regulatory requirements, data analysis, investigations, and inspection readiness.
Experience supporting regulatory inspections, health authority interactions, customer audits, vendor audits, and inspection readiness activities.
Strong knowledge of laboratory operations supporting chemistry, microbiology, bioassay, environmental monitoring, and stability programs.
Experience managing quality control activities at Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and external partners is highly desirable.
Demonstrated 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 such as LIMS, SAP, LMS, electronic quality management systems, and data analytics tools.
Experience with laboratory instrumentation and software platforms, including chromatographic and analytical technologies, is preferred.
Excellent leadership, interpersonal, communication, and stakeholder management skills, with the ability to influence and collaborate effectively across all organizational levels and external partners.
Demonstrated ability to think strategically, solve complex problems, manage multiple priorities, and navigate ambiguity in a dynamic, matrixed environment.
Strong commitment to operational excellence, continuous improvement, innovation, and fostering a culture of compliance, accountability, and teamwork.
Fluent in English, both written and spoken; additional languages are considered an asset. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Rmunration et avantages sociaux Chez Moderna, nous croyons que lorsque vous vous sentez au mieux de votre forme, vous pouvez donner le meilleur de vous-mme.
Cest pourquoi nos avantages sociaux et nos ressources de mieux-tre sont conus pour vous accompagner, au travail,
la maison et partout entre les deux.
Des soins de sant concurrentiels, ainsi que des programmes davantages volontaires adapts vos besoins uniques.
Une approche holistique du bien-tre, avec un accs des services de remise en forme, de pleine conscience et de soutien en sant mentale Des avantages pour la construction familiale, y compris un soutien en matire de fertilit, dadoption et de gestation pour autrui Des congs gnreux, incluant les vacances, les jours fris, les journes de bnvolat, les congs sabbatiques, les journes mondiales de ressourcement, ainsi qu''une fermeture discrtionnaire en fin danne Des solutions dpargne et dinvestissement pour vous aider planifier votre avenir Des avantages et extras spcifiques chaque lieu Les avantages offerts peuvent varier en fonction de la nature de votre emploi chez Moderna et du pays dans lequel vous travaillez propos de Moderna Depuis notre fondation en 2010, nous aspirons btir la principale plateforme technologique dARNm, linfrastructure pour rinventer la manire dont les mdicaments sont crs et distribus, ainsi quune quipe de calibre mondial.
Nous croyons quil est important doffrir nos employs une plateforme pour transformer la mdecine et une opportunit de changer le monde.
En vivant notre mission, nos valeurs et nos faons de penser chaque jour, nos employs sont le moteur de notre progrs scientifique et de notre culture.
Ensemble, nous crons une culture dinclusion et btissons une organisation qui se soucie profondment de ses patients, de ses employs, de lenvironnement et des communauts.
Nous sommes fiers davoir t reconnus comme un des meilleurs employeurs biopharmaceutiques par Science Magazine , un des meilleurs milieux de travail pour les innovateurs par Fast Company , et un excellent lieu de travail aux tats-Unis.
En btissant notre entreprise, nous avons toujours cru quune culture en personne est essentielle notre succs.
Moderna dfend les avantages importants de la collaboration en prsentiel en adoptant un modle de travail 70/30.
Cette structure 70 % au bureau favorise une culture riche en innovation, en travail dquipe et en mentorat direct.
Joignez-vous nous pour faonner un monde o chaque interaction est une opportunit dapprendre, de contribuer et davoir un impact significatif.
Si vous souhaitez faire une diffrence et rejoindre une quipe qui transforme lavenir de la mdecine, nous vous invitons visiter pour en savoir plus sur nos possibilits actuelles.
Moderna est un environnement de travail sans fume, sans alcool et sans drogue.
Moderna est un lieu o chacun peut voluer.
Si vous rpondez aux qualifications de base du poste et que vous tes enthousiaste lide de contribuer notre mission chaque jour, veuillez postuler! Moderna sengage offrir lgalit daccs lemploi et ne pratiquer aucune discrimination envers ses employs ou les candidats qualifis, sans gard la race, la couleur, au sexe, lidentit ou lexpression de genre, lge, la religion, lorigine nationale, lascendance ou la citoyennet, lethnie, un handicap, au statut militaire ou de vtran protg, aux informations gntiques, lorientation sexuelle, ltat civil ou familial, ou toute autre caractristique personnelle protge par la loi en vigueur.
Nous tudions les candidatures qualifies, peu importe les antcdents judiciaires, conformment aux exigences lgales.
Nous nous concentrons sur lattraction, la rtention, le dveloppement et la progression de nos employs.
En cultivant un milieu de travail qui valorise les expriences, les origines et les ides diversifies, nous crons un environnement o chaque employ peut donner le meilleur de lui-mme. ------------------------------------------------------------------------------------------------------------------------------------------------------ Pay & Perks At Moderna, we believe that when you feel your best, you can do your best work.
Thats why our benefits and well-being resources are designed to support youat work, at home, and everywhere in between.
Competitive healthcare, plus voluntary benefit programs to support your unique needs A 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 a discretionary year-end shutdown Savingsandinvestmentsto help you plan for the future Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
📌 Associate Director, Quality Control (Laval)
🏢 Moderna
📍 Laval