Job Overview
Location
Boston
Job Type
Full-time
Category
HR & Recruiting
Date Posted
May 28, 2026
Full Job Description
đź“‹ Description
- • Lead and manage quality oversight of the Company’s GLP programs, including the GLP audit program, collaborating with Quality Systems to develop an annual GLP audit plan.
- • 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 the quality of the Company’s R&D programs to safeguard study participants’ safety and rights and ensure the quality, integrity, and credibility of data generated.
- • Identify and escalate critical quality issues appropriately to QA Management.
- • Assist with the preparation and coordination of regulatory inspections held remotely and onsite at the Company’s offices, clinical trial sites, and contract service provider facilities, as needed.
- • Maintain respectful, inclusive, and effective cross-functional communications, collaborating with internal and external stakeholders on strategy and implementation of quality principles and regulatory requirements while remaining independent.
- • Ensure compliance with relevant legislation and regulations.
- • Develop and propose short- and long-term objectives for the GLP/GCP functions in accordance with overall Company and Quality strategies.
- • Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
- • 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
- • Other duties as assigned
🎯 Requirements
- • 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) is desirable.
- • Experience in conducting audits, adapting issues into effective CAPAs, and evaluating trends to mitigate risks.
- • Proven ability to work independently and collaboratively as part of a multidisciplinary team.
🏖️ Benefits
- • Base salary, target bonus, and stock options.
- • Full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs.
- • Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
- • Vacation, personal days, sick days, and an end-of-year company shutdown.
- • Expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
Skills & Technologies
About Xenon
Xenon is a leading provider of advanced data analytics and artificial intelligence solutions. The company specializes in developing and implementing cutting-edge technologies that help businesses unlock the full potential of their data. Xenon's offerings include predictive modeling, machine learning algorithms, and data visualization tools, all designed to drive informed decision-making and operational efficiency. They serve a diverse range of industries, including finance, healthcare, and retail, empowering clients to gain deeper insights, optimize performance, and achieve strategic business objectives. Xenon is committed to innovation and delivering tangible value through data-driven strategies.
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