Senior Contract Manager building Foundation’s scalable contract practice for enterprise growth. Owning negotiations, templates, workflows, counsel escalation, and contract knowledge systems remotely across the US and Canada.
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.
Academic programs manager supporting pharmacy education and student services at the University of Alberta. Leading operations, governance, resources, and continuous improvement across Faculty programs.
Senior Manager advancing RBC’s financial - crime reporting analytics and automation. Analyzing transaction data, improving STR/SAR systems, and partnering with compliance and technology teams.
Tender Manager negotiating commercial contracts for Nordex, a global onshore wind - turbine manufacturer. Managing execution risks, schedules, and cost estimates to deliver renewable power projects.
API Deployment Manager helping major partners adopt Runway’s AI content - generation technology. Owning technical onboarding, expansion, escalations, and strategic API partnerships.
Global Study Manager leading operational delivery of Parexel’s clinical trials, from study startup through database release and inspection readiness. Overseeing CROs, vendors, budgets, sites, and cross - functional study teams.
LC
Responsable senior de la réussite client chez Lightspeed, plateforme de commerce infonuagique. Fidélisation, adoption produit, expansion et renouvellement d’un portefeuille B2B de plusieurs millions de dollars.
Responsable des contrats commerciaux chez Spiria, créateur canadien de solutions logicielles sur mesure. Révision, négociation et administration contractuelles; gouvernance des programmes de conformité, notamment SOC 2.
Senior Associate Delivery Manager guiding cross - functional software initiatives for DraftKings’ digital sports entertainment and gaming platform. Improving Agile execution, delivery predictability, and roadmap outcomes across US and Canadian remote teams.
Digital Consulting Manager delivering Oracle EPM Planning implementations for Huron, a global consultancy. Managing client projects, technology solutions, and junior - staff development.