Lead Quality Control activities supporting clinical and commercial drug substance and drug product programs in accordance with ICH and cGMP requirementsManage master specifications for starting materials, reference standards, API, and drug productsLead stability activities, including trending, statistical evaluation, scientific interpretation, shelf-life extensions, and expiry dating justificationsManage stability studies and compile protocolsLead OOS and OOT investigations and draft reports with internal teams and external testing laboratoriesReview and manage analytical and non-analytical results for product release and stabilityOrganize and file quality control data, protocols, and reportsManage reference standard qualification and distribution programsLead quality control checks on CMC sections of IND, CTA, and NDA submissionsManage review and approval workflows for feasibility/comparability studies, validation protocols, reports, and test methodsManage internal release documents, including Certificates of Analysis and Certificates of Testing, with QAMaintain relationships with external laboratories and CMOs; participate in remote audits and perform in office audits as requiredCollaborate with Drug Product, API, QA, and cross-functional CMC teamsSupport transfer of new drug candidates from research/discovery to CMC drug developmentOversee sample movement between testing partners and CMOsAssess team capacity and lead assigned teams to meet deliverables, including performance reviewsEngage in deviations, change controls, and CAPAsRecruit, lead, direct, develop, coach,



and evaluate direct reports if applicableEnsure compliance with company policies and code of conductTravel internationally as requiredRequirementsAn undergraduate degree in life sciences8+ years of relevant management experience in the pharmaceutical industryExperience with small molecules and/or biologicsExperience working with external testing laboratoriesExperience with quality control testingExperience managing stability programs in accordance with ICH guidelinesExperience with master specificationsExperience with method validationsExperience with OOS/OOT investigationsExperience with batch release processesExperience with quality management systemsKnowledge of cGMP and the US, Canadian, and EU regulatory environmentsExcellent oral and written communication skillsPrevious team leadership experienceWillingness to travel up to 20% domestically and internationallyExperience auditing external laboratories, FDA/EMA inspections, and inspection readiness preferredPrior experience with IND, BLA, and/or CTA CMC submissions preferredAbility to work across locations and time zonesStrong quality mindsetCore CompetenciesDemonstrates extensive experience in leading Quality Control activities in compliance with ICH and cGMP requirements, managing stability programs, and overseeing analytical results for drug substance and product programs. Proven ability to collaborate with cross-functional teams and manage external relationships while ensuring regulatory compliance.Highest-signal resume keywordsQuality Control TestingStability Program ManagementOOS/OOT InvestigationsCGMP ComplianceTeam LeadershipATS Optimization KeywordsHard SkillsMaster Specifications ManagementMethod ValidationBatch Release ProcessesQuality Management SystemsStatistical EvaluationScientific InterpretationShelf-Life ExtensionsExpiry Dating JustificationsAnalytical Results ReviewCAPA ManagementSoft SkillsExcellent Oral CommunicationExcellent Written CommunicationTeam DevelopmentCoachingRelationship ManagementIndustry KeywordsPharmaceutical IndustryICH GuidelinesCGMPFDA InspectionsEMA InspectionsIND SubmissionsBLA SubmissionsCTA SubmissionsExternal Testing LaboratoriesRegulatory Environments#J-18808-Ljbffr

📌 Associate Director, Quality Control - C$141,400 - C$178,900 A Year (Winnipeg)
🏢 Jobtailor
📍 Winnipeg