Director, Quality Assurance, GCP

Xenon Pharmaceuticals Inc.

Director of Quality Assurance for Xenon Pharmaceuticals, advancing an exciting product pipeline in neuroscience. Building Quality function to support early-stage clinical programs and ensure compliance.

Posted 5/26/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesLead💰 $216,400 - $234,900 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead and manage quality oversight of the Company’s GLP programs
Lead and manage quality oversight of the Company’s early phase clinical programs
Provide expert GLP/GCP compliance interpretation, consultation, training, root cause analysis, and other supportive services necessary to maintain and improve R&D programs
Identify and escalate critical quality issues appropriately to QA Management
Assist with the preparation and coordination of regulatory inspections
Maintain effective cross-functional communications
Ensure compliance with relevant legislation and regulations
Develop and propose short- and long-term objectives for the GLP/GCP functions
Plan and manage budget proposals and approved budgets
Recruit, lead, direct, develop, coach and evaluate direct reports
Act in accordance with Company policies

Requirements

What you’ll need

Bachelor’s degree in a scientific or health field with at least 10 years of GxP QA experience
8+ years GCP QA, supporting both development and commercial programs in the pharmaceutical or biotechnology industry
A minimum of 5 years’ management level experience in a pharma or biotech environment
Contemporary knowledge of GLP/GCP/GVP regulations, guidelines, current industry trends, standards, and methodologies
Experience interacting with regulatory inspectorates (e.g., FDA, Health Canada, EMA, MHRA)
Sound understanding of all phases of the drug development process and the interdependencies with other functional areas
Experience in conducting audits, adapting issues into effective CAPAs, and evaluating trends to mitigate risks
Ability to prioritize work effectively and manage several complex projects in parallel
Strong strategic thinking, excellent organizational skills
Ability to drive project teams forward while having willingness to do hands-on work
Demonstrated ability to interact professionally and communicate clearly, concisely, and consistently both verbally and in writing
Proven ability to work independently and collaboratively as part of a multidisciplinary team
Proficient people management skills including mentorship, negotiation, and conflict resolution.

Benefits

Comp & perks

Base salary
Offers Equity
Offers Bonus
Medical insurance
Dental insurance
Vision insurance
Short- & long-term disability
Accidental death & dismemberment insurance
Life insurance programs
Employee Assistance Program
Travel insurance
Retirement savings programs with company matching contributions
Vacation time
Personal days
Sick days
End-of-year company shutdown
Training, Learning & Development program
Tuition Assistance program for advanced degrees

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GxP QAGCP QAGLP complianceroot cause analysisCAPAauditsdrug development processregulatory inspectionsbudget managementquality oversight

Soft Skills

strategic thinkingorganizational skillsproject managementcommunication skillscollaborationmentorshipnegotiationconflict resolutionleadershipcoaching