Senior Director, Quality Assurance, Commercial

Xenon Massachusetts, United States of America
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· 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. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.