Senior Director, Quality Assurance, Commercial

Xenon Pharmaceuticals•Needham, MA

17d•$258,000 - $281,700•Hybrid

About The Position

Xenon Pharmaceuticals is seeking a Senior Director, Quality Assurance, Commercial to be an integral leader within the Quality GMP team and a key member of the R&D Operations group. This role involves ensuring Quality program requirements are met by leveraging extensive experience in Quality and all manufacturing stages (Drug Substance, Drug Product, Finished Goods) of products for commercial distribution. The successful candidate will demonstrate proven leadership ability in a fast-paced and complex environment, interacting with internal staff, external advisors, and partners. This position reports to the Executive Director, Quality Assurance, GMP and will be based in Needham, MA, USA. This is a hybrid role, requiring a minimum of 2 days per week in the office.

Requirements

Bachelor’s degree in a life sciences discipline.
12+ years of relevant management 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.
Must have experience with virtual manufacturing partners.
Extensive GxP knowledge with commercial production/disposition experience.
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 independently to set priorities to meet timelines.
Previous experience leading and managing on-site and remote employees.

Nice To Haves

An advanced degree is preferred.

Responsibilities

Lead and manage key activities related to commercial manufacturing, testing and disposition of product at CMOs in accordance with regulatory and internal requirements, including batch reviews and release, tech transfers and validations, deviations, quality agreements, and supplier qualifications (auditing and monitoring).
Effectively lead and manage a global team to ensure functional and program objectives are met.
Collaborate and partner with leaders within the CMC and Supply Chain organization to ensure key objectives for commercial programs and small molecule products, ensuring cGMP compliance and realization of value-added policies and best practices.
Recommend and implement strategic system improvements for commercial Quality requirements such as CPV, APR, KPI metrics, as required.
Attend CMO and internal CMC team meetings; provide feedback and collaborate on complex investigations. Escalate or advise key topics, as required.
Support the Quality Systems team and contribute to product review meetings; present Quality metrics (internal and vendor metrics). Provide timely reports and reviews of key CMC and health authority documents.
Represent the Quality function as a trusted advisor on product development teams (PDTs), Health Authority Inspections, for suppliers and at CMO operational meetings, including “QA to QA” meetings.
Promote a Quality and patient-first mindset and inspire Quality excellence 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.