Associate Director, Quality Control

Jobtailor; Vancouver; On-site; CAD 120,000 - 180,000; Full time

Job summary

Jobtailor in Vancouver is seeking a Senior Quality Control leader to drive QC activities for drug substance and product programs in line with ICH and cGMP. You will manage stability programs, oversee analytical results, and coordinate with external labs and CMOs across locations.

The role requires 8+ years in pharma management, experience with stability, OOS/OOT investigations, and IND/BLA/CTA submissions. Travel up to 20% is expected, with strong communication and leadership skills.

Qualifications

• Undergraduate degree in life sciences.
• 8+ years of 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.

Responsibilities

• 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.
• 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.
• Travel internationally as required.

Skills

Quality Control Testing

Stability Program Management

OOS/OOT Investigations

CGMP Compliance

Team Leadership

Statistical Evaluation

Method Validation

Batch Release Processes

Quality Management Systems

Regulatory Knowledge (ICH/US/EU/Canada

Education

Bachelor's degree in life sciences

Tools

Quality Management Systems

Job description

• 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
• 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