Senior Manager/Associate Director, Quality Assurance, Systems

We are seeking a Senior Manager/Associate Director, Quality Assurance, Systems to join our team. We are building the 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 managing and improving Xenon’s Quality Management System.

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:

• Program ownership and oversight of Xenon’s global Quality Management Systems (QMS) including Deviation, Change Control, CAPA and Product Complaints.
• Act as the Business Process Owner for QMS related processes.
• Ensure global quality management systems are effectively designed to provide appropriate support in all GxP areas of the organization.
• Contribute to the overall strategy and execution of electronic platforms used for the QMS processes.
• Manage and prioritize Data Quality Audit (DQA) requests and serve as recall assessment coordinator.
• Establish key metrics; regularly communicate reports to key internal stakeholders to evaluate the effectiveness of Xenon’s QMS. Support Quality Management Review activities and oversee trending of key GMP quality management system performance metrics.
• Oversee and manage the eQMS including workflow configuration and upgrades as needed. Collaborate with stakeholders to identify, define, and implement opportunities for improved QMS Process Workflows.
• Support continuous improvement initiatives of the QMS.
• Assess QMS processes for potential gaps to ensure compliance with regulatory guidelines.
• Act as a Subject Matter Expert (SME) and provide guidance and training on quality events, including but not limited to change control, deviations, investigations, CAPAs and complaints.
• Drive completion of Quality System deviations, CAPAs and change controls.
• Lead quality governance initiatives such as the change control review board as well as other system reviews such as deviation, CAPA and product complaints.
• Support computer systems validation activities as it relates to the eQMS.
• Participate in regulatory inspections and/or internal audits representing Quality Systems
• 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, with at least 5+ years managing in a Quality Systems function.
• Experience working in development and commercial phase companies in a Quality Assurance function.  
• Previous experience with selecting, implementing and maintaining electronic systems (e.g., Veeva, Compliance Wire, Master Control etc.)
• Knowledge of GxP regulations and guidelines as it relates to Quality Systems.
• Ability to work with ambiguity, has a creative approach to problem solving and the ability to define a clear path fwd. with emphasis on keeping things simple.
• 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 in a collaborative team environment is essential along with a customer focused approach.
• Strong decision maker with proven ability to use critical thinking to problem-solve.
• Experience writing, reviewing, and editing SOPs.
• 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.