Director, Quality Assurance – GMP

Xenon Pharmaceuticals Inc.

Director, Quality Assurance, GMP focused on clinical programs at Xenon Pharmaceuticals. Integral member of the Quality GMP team and highly collaborative R&D Operations group.

Posted 5/22/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesLead💰 $210,000 - $231,800 per yearWebsite

About the role

Key responsibilities & impact

Responsible for quality-related matters related to manufacturing, testing and release at a CMO focusing on products in the clinical stage of development
Lead and support activities related to external quality such as batch reviews and release, analytical method validations, tech transfers, deviations, quality agreements, and supplier qualifications
Collaborate with internal CMC functions
Author and review/approve quality documents including quality agreements, dispositions, Quality systems documents, audit reports
Attend CMO and internal CMC team meetings and provide quality feedback
Support quality system and product review meetings
Represent Quality function on project teams, Health Authority Inspections, suppliers and CMO operational meetings
Promote a quality mindset and quality excellence approach throughout the organization
Recruit, lead, direct, develop, coach and evaluate direct reports

Requirements

What you’ll need

Bachelor’s degree in a life sciences discipline
10+ years of experience in GMP quality leadership positions
Strong understanding of small molecule manufacturing
Extensive GxP knowledge with early phase drug development experience
Experience with a small virtual company
Strong knowledge of global GxP expectations and QP (Qualified Person) requirements
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Extensive experience establishing key quality system metrics and process indicators
Strong interpersonal skills
Ability to communicate in a proactive and solution-focused manner
Goal oriented with the ability to troubleshoot and resolve problems
Team building and managing skills including recruiting, coaching, counseling, and disciplining

Benefits

Comp & perks

Medical, dental, vision insurance
Short- & long-term disability
Accidental death & dismemberment
Life insurance
Employee Assistance Program
Travel insurance
Retirement savings programs with company matching contributions
Paid time off including vacation and personal days
End-of-year company shutdown
Tuition Assistance program for advanced degrees

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GMPGxPanalytical method validationtech transferquality agreementssupplier qualificationquality system metricsprocess indicatorssmall molecule manufacturingearly phase drug development

Soft Skills

interpersonal skillscommunicationorganizational skillsmultitaskingproblem-solvinggoal-orientedteam buildingcoachingleadershipevaluating

Certifications

Bachelor’s degree in life sciencesQualified Person (QP)