Senior Manager/Associate Director, Quality Assurance, Systems, Training and Document Control

Boston, MA, USA Req #239

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 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 a Senior Manager/Associate Director, Quality Assurance, Systems, Training and Document Control to join our team. We are building the Quality systems 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 leading and managing Xenon’s Document Management and Training Management systems.

This position reports to the Director, Quality Assurance, Systems and will be in Boston, MA, USA. The level of the position will be commensurate with the candidate’s education and industry experience.

RESPONSIBILITIES:

• Lead and manage the initiation, processing, routing distribution and archiving of controlled documentation in accordance with Xenon’s GXP standards.
• Serve as the subject matter expert for the electronic document management system (eDMS) by ensuring Controlled Documents are managed in accordance with Xenon SOPs. Ensure Controlled Documents follow established standards for creation, revision, approval, and obsolescence.
• Serve as the subject matter expert for Xenon’s electronic learning management system (eLMS), and ensure the system remains in a state of compliance.
• Collaborate with QA leadership and HR on employee training requirements.
• Collaborate with internal stakeholders in IT and key functional areas to continuously improve the eDMS and eLMS systems.
• Report data related to the health of the DMS and LMS to Senior Executive Team via the Quality Management Review.
• Collaborate with internal stakeholders to ensure the framework of quality systems activities align with requirements related to document control and training.
• Oversee computer systems validation related to electronic document and learning management systems. Collaborate with IT as needed.
• Participate in regulatory inspections and/or internal audits.
• Establish and manage effective cross-functional team communications and advise on strategy and implementation of quality principles as well as regulatory requirements while remaining independent.
• 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.
• Some international travel may be required.
• Other duties as assigned.

QUALIFICATIONS:

• Bachelor’s degree with at least 10 years of experience in a quality role, supporting both development and commercial programs.
• Previous experience with implementing and maintaining electronic systems (e.g., Veeva, Compliance Wire, Master Control etc.). Strong track record of successfully managing systems related projects.
• Previous experience with analytics for use in managing quality issues enabling a risk-based approach.
• 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.
• Proven ability to work independently and collaboratively as part of a multidisciplinary team.
• Proficient negotiation and conflict resolution skills.
• Clear, concise, and professional communication skills.

The base salary range for this role is $136,000 to $198,900 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.#J-18808-Ljbffr