Director, Quality Assurance, Systems

Who We Are:
At Xenon Pharmaceuticals ( NASDAQ:XENE ), we are committed to providing a brighter future for patients suffering from neurological disorders. Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver innovative medicines for patients in need. 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 pipeline of neurology-focused therapies, with a focus on commercializing novel treatments for epilepsy. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 Phase 3 epilepsy program includes studies in adult patients with focal onset seizures and primary generalized tonic clonic seizures. In addition, XEN1101 is being evaluated as a treatment for major depressive disorder in both a company-sponsored Phase 2 clinical trial, as well as an investigator-led proof-of-concept study. We are also proud of the leading-edge science coming out of our discovery labs, where many innovative, early-stage research programs are underway. In addition to these proprietary programs, our pipeline includes clinical-stage partnered programs. 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 Director, Quality Assurance, Systems, to be an integral member of Xenon’s dedicated QA team. The Director, Quality Assurance, Systems will work collaboratively with multidisciplinary teams and ensure adherence to regulatory requirements in a fast-paced, multi-location workplace. This position reports to the Senior Vice President, Quality Assurance and will be located in either Vancouver, BC, Canada or Boston, MA, USA; we may consider other locations for an exceptional candidate.
RESPONSIBILITIES:

• Establish processes for accurately tracking, reporting, and analyzing quality system metrics.
• Act as the quality system owner of, but not limited to, Deviation Management (Non-Conformances), CAPA, Change Control, and Risk Management processes. Identify and lead quality system changes and continuous improvement initiatives through collaboration and engagement with system users.
• 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 required from time to time.
• Assess and manage the overall eQMS, including the evaluation of electronic quality systems and ongoing management and user training of the current eQMS, ensuring the QMS evolves with the appropriate clinical phase of development.
• Collaborate with key stakeholder members in Development and Commercial, and Corporate teams as necessary to ensure GxP training, documentation, and systems requirements are met
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Develop and propose short- and long- term objectives for the function in accordance with overall Company strategies and plans.
• Lead and manage Quality Management Review process and meetings. Schedule meetings, present metrics, take minutes, and escalate issues accordingly.
• Ensure quality systems are appropriately designed, configured and implemented and measure for compliance and effectiveness.
• Recruit, develop, and mentor direct reports, if any, in accordance with the Company’s Human Resource policies and practices.

QUALIFICATIONS:

• Demonstrated analytical and critical thinking skills. Strong experience with quality investigations, assessments, reviews and/or evaluations of quality events (Deviations, CAPAs, Change Control).
• Bachelors or Masters (preferred) degree from an accredited institution in a scientific or health related field with 8 years of proven experience in pharmaceutical quality assurance, including international quality assurance with substantial experience in GxP.
• Experience with FDA/EMA inspections and inspection readiness activities.
• Demonstrated ability to effectively organize and execute tasks, working independently and collaboratively as part of a multidisciplinary team with good analytical, problem-solving, and negotiation skills.
• Experience with implementing an eQMS is a plus.
• Advanced knowledge and demonstrated experience in the applicable GxP regulations, FDA Good Manufacturing and Clinical Practices, ICH Guidelines, Global Drug Development Regulations and Guidances and Computer System Validation.
• Strong organizational and time management skills and good attention to detail to effectively prioritize and manage complex projects, ensuring quality deliverables by established timelines with minimal supervision.
• Willingness to travel up to 15% of the time, both domestically and internationally.
• Excellent oral and written communication skills (including presentation) and experience collaborating with cross-functional stakeholders.
• Risk Management experience. Excellent problem-solving skills and experience facilitating risk assessments.

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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