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

Internal Number: 239

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.