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 in office 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
Strong 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 (British Columbia)
🏢 Jobtailor
📍 British Columbia