Senior QA Lead, GCP/GLP for Early-Phase Trials

Xenon Pharmaceuticals Inc.; Needham (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Stock options

Base salary + target bonus

Medical, dental, vision

Life insurance

Retirement savings with company match

Employee Assistance Program

Time off and holidays

Job summary

Xenon Pharmaceuticals Inc., a neuroscience-focused biopharmaceutical company, seeks a Senior Manager/Associate Director, Quality Assurance, GCP, to join the Boston-area team. The role supports early-phase clinical programs and inspection readiness, ensuring GCP and GLP compliance across R&D operations.

Based in Boston/Needham with hybrid onsite requirement, you will lead QA activities, drive quality plans, oversee audits, and collaborate with internal and external stakeholders to safeguard

Qualifications

• Bachelor’s degree in a scientific or health field with at least 8 years of GxP QA experience, 6+ years GCP QA, supporting development and commercial programs.
• At least 3 years in a quality lead role in pharma/biotech; level commensurate with experience.
• Extensive knowledge of GCP regulations, guidelines, trends, standards and methodologies.
• GLP knowledge and practice aligned with industry standards and methodologies.
• Experience interacting with regulatory inspectorates (FDA, Health Canada, EMA, MHRA) is desirable.
• Strong understanding of all drug development phases; early phase (pre-phase 3) experience required.
• Audits, CAPA development, trend evaluation to mitigate risks.
• Prioritization and management of multiple complex projects to meet milestones.
• Strategic thinking, organizational skills, and ability to lead project teams.
• Clear, professional communication with internal/external stakeholders.
• Ability to work independently and in multidisciplinary teams.

Responsibilities

• Serve as the quality representative for assigned early phase clinical programs, developing Quality Plans and overseeing Quality Tolerances.
• Support GLP program oversight, including audits and annual plan development with Quality Systems.
• Provide GLP/GCP interpretation, training, root cause analysis, and data integrity support for R&D programs.
• Identify and escalate critical quality issues to QA Management.
• Assist with regulatory inspections remotely and onsite at offices, sites, and CRO facilities.
• Maintain effective cross-functional communications with stakeholders on quality strategies and regulatory requirements.
• Support short- and long-term objectives for GLP/GCP functions aligned with company strategies.
• Adhere to company policies and code of ethics; guide direct reports where applicable.
• Other duties as assigned.

Skills

GxP QA

GCP QA

GLP

Audits

CAPA

Regulatory inspections

Cross-functional collaboration

Project leadership

Communication

Education

Bachelor's degree in science

Job description

Xenon Pharmaceuticals Inc., a neuroscience-focused biopharmaceutical company, seeks a Senior Manager/Associate Director, Quality Assurance, GCP, to join the Boston-area team. The role supports early-phase clinical programs and inspection readiness, ensuring GCP and GLP compliance across R&D operations.

Based in Boston/Needham with hybrid onsite requirement, you will lead QA activities, drive quality plans, oversee audits, and collaborate with internal and external stakeholders to safeguard