Xenon Pharmaceuticals Inc. · 17 hours ago
Associate Director/Director, Quality Assurance, GCP
Boston, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$169K/yr - $235K/yr
10+ years expXenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery and clinical development. They are seeking an Associate Director/Director of Quality Assurance, GCP to build the GCP Quality function and ensure compliance within R&D Programs, contributing to inspection readiness initiatives.
BiotechnologyHealthcarePharmaceuticalLife ScienceBiopharmaGeneticsHealth CareMedical
Responsibilities
Ensure the Company’s quality systems and activities are actively managed to include, but not limited to quality risk management, inspection readiness, quality issue management, data quality auditing, and GLP/GCP training
Manage internal and external GLP/GCP audit programs and activities, collaborating with key stakeholders to ensure quality compliance for current and future programs
Provide GLP/GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of the Company’s R&D programs to ensure the protection of study participants’ safety and rights and the quality, integrity, and credibility of data generated
Identify and escalate critical quality issues appropriately to QA Management; support investigations as required
Collaborate with internal departments to implement quality principles and regulatory requirements while remaining independent
Lead and manage GLP/GCP inspection readiness activities in preparation for pre-approval inspections
May contribute to GVP activities, as required
Participate in regulatory inspections held at the Company’s offices, clinical study sites, and contract service provider facilities, as needed
Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
Some international travel may be required
Other duties as assigned
Qualification
Required
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. Job level commensurate with years of experience
Contemporary knowledge of GLP/GCP/GVP regulations, guidelines, current industry trends, standards, and methodologies
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 to manage several complex projects in parallel, and successfully achieve critical milestones and expected deliverables within established timelines and budgets
Must be able to demonstrate strategic thinking, excellent organizational skills and be able to drive project teams forward while having willingness to do hands on work to achieve goals
Demonstrated ability to interact professionally and communicate clearly, concisely, and consistently both verbally and in writing with internal and external stakeholders
Proven ability to work independently and collaboratively as part of a multidisciplinary team
Proficient people management skills including mentorship, negotiation, and conflict resolution
Preferred
Experience interacting with regulatory inspectorates (e.g., FDA, Health Canada, EMA, MHRA) is desirable
Benefits
Medical
Dental
Vision
Short-& long-term disability
Accidental death & dismemberment
Life insurance programs
Employee Assistance Program
Travel insurance
Retirement savings programs with company matching contributions
Vacation
Personal days
Sick days
End-of-year company shutdown
Training, Learning & Development program
Tuition Assistance program for advanced degrees
Company
Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need.
201-500 employees
H1B Sponsorship
Xenon Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.29BKey Investors
Neurocrine Biosciences
2023-11-29Post Ipo Equity· $300M
2022-06-22Post Ipo Equity· $287.5M
2021-10-05Post Ipo Equity· $345M
Leadership Team
Ian Mortimer
President & CEO
Tucker Kelly
Chief Financial Officer
Recent News
2026-01-13
2025-12-05
2025-11-25
Company data provided by crunchbase