Senior Manager/Associate Director, Quality Assurance, GCP

Who We Are:

Xenon Pharmaceuticals ( NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

What We Do:

We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations .

About the Role:

We are seeking a Senior Manager/Associate Director, Quality Assurance, GCP to join our team. We are building the GCP Quality function to support Xenon’s late-stage clinical development programs and prepare for commercialization, as well as expand quality initiatives across the company. This position will be a key contributor to inspection readiness initiatives and for ensuring compliance within R&D Programs.

This position reports to the Executive Director, Quality Assurance, GCP and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience.

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/GVP training.
• Manage internal and external GLP/GCP/GVP audit programs and activities, collaborating with key stakeholders to ensure quality compliance for current and future programs.
• Provide GLP/GCP/GVP 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/GVP inspection readiness activities in preparation for pre-approval inspections.
• 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.
  
  

QUALIFICATIONS:

• 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.
• 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.
• 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.
  
  

The base salary range for this role is $133,600 to $200,600 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a 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.

Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here .

To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

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