Associate Director/Director, Quality, Regulatory

4 weeks ago


Vancouver BC, Canada Xenon Pharmaceuticals Inc. Full time €123,700 - €183,800
Associate Director/Director, Quality, Regulatory & Supply Chain Systems

Who We Are:

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 XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures. In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 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 an Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information Systems, to join our team. This role will be the IT business partner for the Quality, Regulatory and Supply Chain functions and will be the primary point of contact on all topics related to IT. The Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information System will partner with these groups to develop and execute against a functional technology roadmap, support existing enterprise applications (e.g. MasterControl eQMS), design and build effective and compliant data flows, and ensure compliance with relevant regulations (e.g. GxP and 21 CFR Part 11). The successful candidate will facilitate the design and adoption of effective data governance and lifecycle management processes, including the design and adoption of new technology to support these practices as needed. The Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information System will play a central role in the company’s planned implementation of a new ERP system, in collaboration with functional colleagues and the Director, Enterprise Applications. The successful candidate will act as the primary point of contact for the designated user groups on all topics related to IT and will partner with colleagues in IT to resolve issues and deliver solutions. S/he will also ensure that IT-sponsored initiatives and standards are tailored to meet the needs of the QR&SC functions and are successfully adopted.

This Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information System role is a hands-on position with the expectation that their team will expand over time as new systems are implemented and as the IT operating model evolves. During this period of rapid growth and evolution, the Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) Information System will be assigned additional responsibilities (beyond the core responsibilities described) based on company needs, the individual’s experience and expertise, and the availability of resources within IT.

This position reports to the Senior Vice President, Information Systems and will be located in the Vancouver, BC, Canada area. The level of the position will be commensurate with the candidate’s education and industry experience.

RESPONSIBILITIES:

  • Act as the IT owner for all QR&SC information systems and collaborate with functional system owners and colleagues in IT to evolve the support model based on the needs of the users and the overall IT strategy.
  • Partner with key stakeholders in the QR&SC functions to develop and execute against a functional technology roadmap encompassing current and future systems to address existing pain points, maximize the usage and value of existing systems, and develop new capabilities as needed.
  • Serve as the primary point of contact between the QR&SC functions and IT to resolve issues, align on processes and standards, and ensure awareness and alignment on key initiatives (function- or IT-sponsored). Ensure that IT standards and processes are tailored to meet the unique needs and capabilities of the QR&SC functions.
  • Facilitate effective IT planning, governance, and project delivery as these processes evolve.
  • Actively collaborate with other IT business partners to manage common or cross-functional requirements and project dependencies, and to ensure an effective enterprise approach to system planning and design.
  • Collaborate with the Associate Director/Director, Data Architecture & Engineering to ensure effective and secure data exchange with external vendors and service providers, and to facilitate the design and adoption of effective data governance and lifecycle management processes and tools to control data lineage.
  • Design, develop, and document effective data flows and integrations among systems to enable efficient processes and workflows (including automation) and effective reporting and analytics.
  • Collaborate with functional stakeholders and with the Quality department to ensure relevant systems are built and maintained in compliance with regulatory requirements and internal policies and procedures.
  • Manage vendor relationships (e.g. software and service providers) in the context of both project delivery and ongoing operations to maximize value to Xenon.
    As a member of the IT Leadership Team, contribute to the development and execution of the strategy to evolve the overall IT operating model, including new structure, processes, and ways of working.
  • Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
  • 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.

QUALIFICATIONS:

  • Minimum undergraduate degree in Computer Science, Informatics, or related discipline.
  • At least 8 years of progressive information technology experience in a similar role, with at least 3 years in a leadership/management role.
  • Demonstrated ability to set direction and lead while simultaneously performing hands-on work.
  • Experience working in a regulated environment including extensive knowledge of system validation requirements and frameworks.
  • Domain knowledge of the work performed with the Quality, Regulatory & Supply Chain functions, including the ability to effectively collaborate with functional stakeholders.
  • Proven ability to diagnose and solve problems, and to identify opportunities to more effectively leverage technology and data to drive agility, efficiency, insights, and compliance.
  • Broad knowledge base of cloud technology offerings as they relate to life sciences.
  • Excellent written and verbal communication skills with the ability to explain highly technical information in a concise and effective manner to an audience of varying technical aptitude.
  • Strong interpersonal skills that support quickly building rapport with IT colleagues, functional stakeholders, and external vendors; ability to manage competing interests in a professional, collaborative and solution-driven manner.
  • Ability to work flexibly in a fast-paced environment with a strong work ethic and positive attitude.
  • Demonstrated ability to lead continuous improvements in development processes and practices.

The base salary range for this role is $123,700 to $183,800 CAD ; 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.

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.

#J-18808-Ljbffr

  • Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

    **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,...

  • Associate Director

    2 months ago


    Vancouver, BC, Canada Xenon Pharmaceuticals Inc. Full time

    Associate Director/Director, Quality, Regulatory & Supply Chain Systems We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon...


  • Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

    Associate Director/Director, Regulatory Affairs Friday, March 8, 2024 Who We Are: 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...


  • Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

    Associate Director/Director, Regulatory Affairs Friday, March 8, 2024 Who We Are: 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...


  • Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

    Associate Director/Director, Regulatory Affairs Friday, March 8, 2024 Who We Are: 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...


  • Vancouver, BC, Canada Quality Forum Full time

    University of British Columbia UBC Health UBC Health reports to the Office of the Vice-President, Health and serves as a resource to all health disciplines at UBC. It is responsible for driving the vision of the Vice-President, Health portfolio by promoting an integrated approach to collaboration among all health programs at UBC and with external...


  • Vancouver, BC, Canada Quality Forum Full time

    Organization: University of British Columbia UBC Health UBC Health reports to the Office of the Vice-President, Health and serves as a resource to all health disciplines at UBC. It is responsible for driving the vision of the Vice-President, Health portfolio by promoting an integrated approach to collaboration among all health programs at UBC and with...


  • Vancouver, BC, Canada Innivec Full time

    Job Summary: The Director of Academics at Innivec will be responsible for overseeing the development, implementation, and evaluation of educational programs and initiatives. This leadership position will focus on ensuring the highest standards of academic excellence, instructional quality, and student success across all educational programs. The Director...

  • Partnership Director

    1 month ago


    Langley, BC, Canada BC Trucking Association Full time

    The BC Trucking Association (BCTA) is currently seeking a visionary and strategic leader to join our team as the Director of Policy. This position plays a pivotal role in shaping the Association’s policy agenda and advocacy efforts. The Director of Policy’s main responsibility is to develop and implement a comprehensive policy strategy aligned with...


  • Vancouver, Canada PHSA Full time

    **Job Summary**: In accordance with the Mission, Vision and Values, and strategic directions of PHSA, safety, including both patient and employee safety, is a priority and a responsibility shared by everyone at PHSA. As such, the requirement to continuously improve quality and safety is inherent in all aspects of this position. The Director, Clinical...


  • Greater Vancouver Regional District, BC, Canada Penta Search Group Full time

    Penta Search Group has been retained by a global medical device manufacturer to identify a Director of Engineering to be based in their R&D and Manufacturing facility in Burnaby, BC.Overseeing a team of Engineers, you will play an integral part in leading research and development efforts for the business. You will:Develop and implement R&D strategies Lead...


  • Greater Vancouver Regional District, BC, Canada Penta Search Group Full time

    Penta Search Group has been retained by a global medical device manufacturer to identify a Director of Engineering to be based in their R&D and Manufacturing facility in Burnaby, BC.Overseeing a team of Engineers, you will play an integral part in leading research and development efforts for the business. You will:Develop and implement R&D strategies Lead...


  • Vancouver, BC, Canada College of Pharmacists of British Columbia Full time

    Who We Are Founded in 1891, the College of Pharmacists of British Columbia is located on the traditional, ancestral and unceded lands of the xʷməθkʷəy̓əm (Musqueam), Sḵwx̱wú7mesh (Squamish), and səlilwətaɬ (Tsleil-Waututh). The College is a BC health regulatory body and is a vital link in the chain of trust between patients, pharmacists and...


  • , BC, Canada Penta Search Group Full time

    2 days ago Be among the first 25 applicants This range is provided by Penta Search Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range CA$150,000.00/yr - CA$230,000.00/yr Direct message the job poster from Penta Search Group Manufacturing & Engineering Talent...

  • Director, Legal

    3 weeks ago


    Vancouver, BC, Canada Medisca Pharmaceuticals Inc. Full time

    LGM Financial Services Inc. (“As Canada’s best automotive partner, we will revolutionize the consumer ownership experience. LGM is a national leader in providing warranty, finance and insurance services to the Canadian automotive industry. Since 1998, LGM has been successfully supplying quality products and leading training solutions to Canadian...


  • Vancouver, BC, Canada BioTalent Canada Full time €165,000 - €233,300

    Home > Job Postings > Associate Director/Director, Clinical Programming & Data Standards 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...


  • Vancouver, BC, Canada Xenon Pharmaceuticals Inc. Full time €153,200 - €209,000

    Associate Director/Director, Clinical Programming & Data Standards Who We Are: 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...


  • Greater Vancouver Regional District, BC, Canada Penta Search Group Full time

    Penta Search Group has been retained by a global medical device manufacturer to identify a Director of Engineering to be based in their R&D and Manufacturing facility in Burnaby, BC. Overseeing a team of Engineers, you will play an integral part in leading research and development efforts for the business. You will: Develop and implement R&D strategies ...


  • Vancouver, Canada OMD Canada Full time

    TITLE: ASSOCIATE DIRECTOR OF STRATEGY REPORTING TO: GROUP DIRECTOR OF STRATEGY OR MANAGING DIRECTOR OVERALL RESPONSIBILITIES The Associate Director is the day-today contact on the business and is responsible for maintaining the client relationship and internal relationships with the agency accoun


  • Vancouver, BC, Canada The Nature Conservancy Full time €100,000

    The Nature Conservancy Associate Director of Development (54834) Tulsa , Oklahoma Apply Now OFFICE LOCATION Cleveland, OH USA\#Li-remote #As a science-based organization, wedevelop innovative, on-the-ground solutions to the worlds toughestenvironmental challenges so that people and nature can thrive. Our workis guided by our values, which include...