Senior Director, Quality Assurance, Commercial

Xenon Pharmaceuticals•Needham, MA

15d•Hybrid

About The Position

We are seeking a Senior Director, Quality Assurance, Commercial as an integral leader within the Quality GMP team as well as a key member of highly collaborative R&D Operations group comprised of Program Management, CMC, Regulatory Affairs, Supply Chain and Quality functions. Leveraging an extensive background in Quality and all manufacturing stages (Drug Substance, Drug Product, Finished Goods) of products for commercial distribution 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 with external advisors and partners. This position reports to the Executive Director, Quality Assurance, GMP and will be based out of Boston, MA, USA in our Needham office. We may consider other jurisdictions for exceptional candidates. 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 12+ years of relevant management experience in GMP quality leadership positions; an advanced degree is preferred.
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. This includes, but not limited to, batch reviews and release, tech transfers and validations, deviations, quality agreements, and supplier qualifications including 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; ensure 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 to 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.