Lead Quality Control activities supporting clinical and commercial drug substance and drug product programs in accordance with ICH and cGMP requirements Manage master specifications for starting materials, reference standards, API, and drug products Lead stability activities, including trending, statistical evaluation, scientific interpretation, shelf-life extensions, and expiry dating justifications Manage stability studies and compile protocols Lead OOS and OOT investigations and draft reports with internal teams and external testing laboratories Review and manage analytical and non-analytical results for product release and stability Organize and file quality control data, protocols, and reports Manage reference standard qualification and distribution programs Lead quality control checks on CMC sections of IND, CTA, and NDA submissions Manage review and approval workflows for feasibility/comparability studies, validation protocols, reports, and test methods Manage internal release documents, including Certificates of Analysis and Certificates of Testing, with QA Maintain relationships with external laboratories and CMOs; participate in remote audits and perform on-site audits as required Collaborate with Drug Product, API, QA, and cross-functional CMC teams Support transfer of new drug candidates from research/discovery to CMC drug development Oversee sample movement between testing partners and CMOs Assess team capacity and lead assigned teams to meet deliverables, including performance reviews Engage in deviations, change controls, and CAPAs Recruit, lead, direct, develop, coach, and evaluate direct reports if applicable Ensure compliance with company policies and code of conduct Travel internationally as required Requirements





An undergraduate degree in life sciences 8+ years of relevant management experience in the pharmaceutical industry Experience with small molecules and/or biologics Experience working with external testing laboratories Experience with quality control testing Experience managing stability programs in accordance with ICH guidelines Experience with master specifications Experience with method validations Experience with OOS/OOT investigations Experience with batch release processes Experience with quality management systems Knowledge of cGMP and the US, Canadian, and EU regulatory environments Excellent oral and written communication skills Previous team leadership experience Willingness to travel up to 20% domestically and internationally Experience auditing external laboratories, FDA/EMA inspections, and inspection readiness preferred Prior experience with IND, BLA, and/or CTA CMC submissions preferred Ability to work across locations and time zones Solid quality mindset Core Competencies

Demonstrates 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 keywords

Quality Control Testing Stability Program Management OOS/OOT Investigations CGMP Compliance Team Leadership ATS Optimization Keywords

Hard Skills

Master Specifications Management Method Validation Batch Release Processes Quality Management Systems Statistical Evaluation Scientific Interpretation Shelf-Life Extensions Expiry Dating Justifications Analytical Results Review CAPA Management Soft Skills

Excellent Oral Communication Excellent Written Communication Team Development Coaching Relationship Management Industry Keywords

Pharmaceutical Industry ICH Guidelines CGMP FDA Inspections EMA Inspections IND Submissions BLA Submissions CTA Submissions External Testing Laboratories Regulatory Environments

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📌 Associate Director, Quality Control (Winnipeg)
🏢 Jobtailor
📍 Winnipeg