Associate Director, Quality Control
Core
Establish and operate a world-class Quality Control organization supporting commercial manufacturing of mRNA vaccines and biopharmaceuticals.
Role type
Associate Director, Quality Control (Manufacturing)
Builds
Commercial manufacturing operations for mRNA vaccines and biopharmaceuticals
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic and operational leadership in Quality Control, GxP regulatory compliance (FDA, Health Canada, EMA, ICH), analytical testing, microbiology, environmental monitoring, critical utilities monitoring, release testing, stability programs, method transfer, validation, CAPA management, OOS/OOT investigations, contract manufacturing oversight, team development, budget management, technical documentation, LIMS/SAP systems proficiency
Preferred skills
Environmental monitoring strategies, contamination control, utility monitoring, regulatory inspection readiness, CMO/CTL management, complex project leadership, data analytics, laboratory instrumentation expertise
Technologies
LIMS, SAP, LMS, electronic quality management systems, chromatographic platforms, AI-enabled tools
Responsibilities
Provide strategic and operational leadership for QC activities supporting commercial manufacturing; Lead startup and operational readiness of QC laboratories for drug substance and product testing; Supervise analytical testing, microbiology, environmental monitoring, utilities, release, and stability programs; Ensure compliance, data integrity, and inspection readiness; Manage relationships with CMOs, CTLs, and external partners; Drive method transfers, validations, and change controls; Lead complex investigations and CAPA processes; Develop and mentor high-performing QC teams; Contribute to department strategy, resource planning, and budget management; Represent QC in regulatory interactions and audits.
Seniority
Senior, hands-on IC with strategic leadership
