General Management Support Manager coordinating caisse strategy, HR, communications and budgets at Desjardins. Supporting executive governance, talent development, labor relations and community representation.
About the role
- Quality Control leader supporting Xenon Pharmaceuticals’ neuroscience drug programs through release, stability, testing, and CMC submissions. Managing external labs, CMOs, investigations, specifications, and clinical-to-commercial manufacturing activities.
Responsibilities
- Lead Quality Control activities supporting clinical and commercial drug substance and drug product programs in accordance with ICH and cGMP requirements
- Review and manage analytical and non-analytical results for product release and stability, including OOS and OOT observations
- Organize and file internal and external quality control data, protocols, and reports
- Lead stability activities, including trending, statistical evaluation, scientific interpretation, shelf-life extensions, expiry dating justifications, and emerging risk evaluation
- Manage reference standards, master specifications, and stability studies for assigned programs
- Lead investigations and draft reports for OOS and OOT results
- Manage review and approval workflows for feasibility/comparability studies, validation protocols, reports, and test methods
- Lead quality control checks on CMC sections of IND, CTA, and NDA regulatory submissions
- Manage internal release documents, including Certificates of Analysis and Certificates of Testing, in collaboration with QA
- Collaborate with Drug Product and API groups to optimize clinical trial material deliverables
- Manage relationships with external laboratories and CMOs, participate in remote audits, and perform onsite audits as required
- Support transfer of new drug candidates from research/discovery to the CMC drug development team
- Oversee sample movement between external testing partners and CMOs for tech transfers, release, and stability testing
- Ensure compliance with deviations, change controls, and CAPAs
- May recruit, lead, direct, develop, coach, and evaluate direct reports
- Ensure company policies are understood and followed by direct reports
- Travel internationally as required
- Perform other duties as assigned
Requirements
- Undergraduate degree in life sciences
- 5+ years of relevant management experience in the pharmaceutical industry for Senior Manager level, or 8+ years for Associate Director level
- Experience with small molecules and/or biologics
- Experience working with external testing laboratories
- Ability to work independently and influence in a fast-paced environment while exhibiting a strong quality mindset
- Comfortable working across locations and time zones
- Experience with quality control testing
- Experience managing stability programs in accordance with ICH guidelines
- Experience with master specifications, method validations, OOS/OOT investigations, batch release processes, and quality management systems
- Knowledge of cGMP and US, Canadian, and EU regulatory environments
- Experience auditing external laboratories, FDA/EMA inspections, and inspection readiness preferred
- Prior experience with IND, NDA, and/or CTA CMC submissions preferred
- Excellent oral and written communication skills
- Previous team leadership experience
- Collaboration and inclusion between external testing labs and cross-functional CMC teams
- Willingness to travel up to 20% domestically and internationally
- Ability to work onsite at least two days per week for the hybrid role
- For the Vancouver application, authorization to work in Canada without restrictions based on citizenship or immigration status
Benefits
- Base salary
- Target bonus
- Stock options
- Medical insurance
- Dental insurance
- Vision insurance
- Short-term disability insurance
- Long-term disability insurance
- Accidental death & dismemberment insurance
- Life insurance
- Employee Assistance Program
- Travel insurance
- Retirement savings programs with company matching contributions
- Vacation days
- Personal days
- Sick days
- End-of-year company shutdown
- Training, Learning & Development program
- Tuition Assistance program for advanced degrees
- Hybrid work arrangement
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Study Manager leading budgets, schedules, teams and feasibility studies for Wood’s global mining and metals consulting business. Overseeing safe, timely delivery for major mining clients.
Manager cultivating transformational donors for MS Canada, which supports people affected by multiple sclerosis. Building major - gift portfolios and philanthropic relationships across Canada.
Regional Manager driving revenue, provider recruitment, and compliance across Canada for Confident Remodels’ installed home - improvement platform. Managing contractor performance, metrics, partnerships, and frequent field travel.
Market Development Manager leading financial product sales, member relationships, and team performance for Desjardins Ontario Credit Union. Driving strategic growth, service quality, talent development, and profitability.
A(
Investment technology leader managing teams and critical platforms for AIMCo, a Canadian institutional investment manager. Supporting investment, risk, trading, treasury, and compliance operations.
Contract Manager leading contract strategy, risk, claims, and negotiations for GE Vernova’s major hydroelectric projects. Fully remote in British Columbia with 15 - 25% project - related travel.
Senior Contract Manager leading commercial strategy, risk, claims, and negotiations for GE Vernova's Canadian hydroelectric projects. Managing contracts from bid through execution, close - out, and warranty.
Contract Manager leading complex hydroelectric project contracts for GE Vernova’s energy business in British Columbia. Managing commercial risk, negotiations, changes, claims, and disputes.
Senior Contract Manager leading contract strategy, risk, claims and negotiations for GE Vernova's Canadian hydroelectric projects. Managing commercial interests from bid through execution, close - out and warranty.