Overview
Associate Director, Quality Control Jobs in Laval, Canada at Moderna
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 Moderna’s 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:
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Provide strategic and operational leadership for Quality Control activities supporting commercial manufacturing, product lifecycle management, laboratory operations, and external partner oversight.
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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.
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Oversee analytical testing, microbiology, environmental monitoring, critical utilities monitoring, release testing, and stability programs across internal laboratories and external networks.
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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.
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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.
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Provide strategic oversight of Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and other external testing partners to ensure quality, compliance, and operational excellence.
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Lead analytical method transfers, qualifications, validations, and implementation of analytical changes supporting commercial products, new product introductions, and technology transfer activities.
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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.
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Lead complex technical investigations and ensure effective management of deviations, OOS/OOT investigations, CAPAs, change controls, and other quality system processes.
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Support process validation, PPQ campaigns, regulatory submissions, Annual Product Quality Reviews (APQRs), and product lifecycle management activities.
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Represent Quality Control during regulatory inspections, health authority interactions, customer audits, vendor audits, and internal audits while maintaining a continuous state of inspection readiness.
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Build, develop, and lead high-performing Quality Control teams through…
Title: Associate Director, Quality Control
Company: Moderna
Location: Laval, Canada
Category: