Director, Quality Assurance, GMP

Xenon Pharmaceuticals•Needham, MA

5d•$210,000 - $231,800•Hybrid

About The Position

Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics. We are seeking a Director, Quality Assurance, GMP focusing on clinical programs to join our team. This position will be an integral member of the Quality GMP team as well as a key member of highly collaborative R&D Operations group comprised of Program Management, CMC, Regulatory, Supply Chain and Quality functions. Leveraging an extensive background in quality and manufacturing in all clinical phases will ensure the quality program requirements are met. The successful candidate will have proven leadership ability in a fast-paced and complex environment, and will interact with all levels of internal staff, as well as external advisors and partners. This position reports to the Executive Director, Quality Assurance, GMP and will be based out of Vancouver, BC, Canada or Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Relocation and immigration support will be provided, if required. This role is a hybrid position, requiring a minimum of 2 days per week in the office.

Requirements

Bachelor’s degree in a life sciences discipline, with 10+ years of experience in GMP quality leadership positions.
Strong understanding of small molecule manufacturing including drug substance manufacture, drug product manufacture with direct experience in solid oral dosage and finished goods production and distribution.
Extensive GxP knowledge with early phase drug development experience.
Experience with a small virtual company.
Strong knowledge of global GxP expectations and QP (Qualified Person) requirements.
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment.
Extensive experience establishing key quality system metrics and process indicators to proactively identify and address quality systems or product issues.
Strong interpersonal skills, with experience in leading cross functional projects including a successful track record working with suppliers and CMOs.
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Ability to communicate issues with CMOs.
Goal oriented with the ability to troubleshoot and resolve problems.
Be a champion for continuous improvement in all aspects of total quality management.
Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others.
Team building and managing skills including recruiting, coaching, counseling, and disciplining.

Responsibilities

Responsible for quality-related matters related to manufacturing, testing and release at a CMO (Contract Manufacturing Organization) focusing on products in the clinical stage of development.
Lead and support activities related to external quality such as, but not limited to, batch reviews and release, analytical method validations, tech transfers, deviations, quality agreements, and supplier qualifications including auditing and monitoring.
Collaborate with internal CMC functions and aligns goals and objectives for clinical phase programs and small molecule products, ensuring cGMP compliance and realization of value-added policies and best practices.
Author and review/approve quality documents including quality agreements, dispositions, Quality systems documents, audit reports, etc....
Attend CMO and internal CMC team meetings and provide quality feedback supporting Xenon products including collaborations on complex investigations.
Support quality system and product review meetings including providing data for quality metrics (internal and vendor metrics). Provide quality reviews of key CMC and health authority documents. Review and verify data to assure compliance with data integrity.
Represent Quality function on project teams, Health Authority Inspections, suppliers and CMO operational meetings, and QA to QA meetings.
Promote a quality mindset and quality excellence approach throughout the organization.
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.