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Executive Director, Quality Assurance, GMP

1 month ago

Boston, United States Xenon Inc Full time
Who We Are:

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

What We Do:

We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.

About the Role:

We are seeking an Executive Director, Quality Assurance, GMP to join our team. This Executive Director, Quality Assurance, GMP will be an integral member of the Quality leadership team as well as a key member of highly collaborative R&D Operations group comprised of Program Management, CMC, Regulatory, and Quality functions. Leveraging an extensive background in quality and manufacturing in all clinical phases through to commercial, will ensure the quality program requirements are met.

The Executive Director, Quality Assurance, GMP 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 Senior Vice President, Quality Assurance and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates.

RESPONSIBILITIES:
  • Responsible for all quality-related matters related to manufacturing, testing and release at a CMO (Contract Manufacturing Organization); act as the technical subject matter quality expert for all matters governed by GMP related regulations and guidelines as it relates to manufacturing, testing and controls.
  • 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 from clinical to commercial phase programs and small molecule products, ensuring cGMP compliance and realization of value-added policies and best practices.
  • Ensure quality policies and objectives are understood, implemented, and maintained for all applicable GMP roles. Identifies gaps and provides solutions for new processes and documents to ensure readiness for inspections and audits.
  • Author and review or approve quality documents including quality agreements, certificates of release, and audit reports.
  • Attend CMO and internal CMC team meetings and provide quality feedback supporting Xenon products including collaborations on complex investigations.
  • Attend and 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.
  • 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:
  • A bachelor's degree in a life sciences discipline, with 12+ years of experience in GMP quality leadership positions.
  • Strong understanding of small molecule manufacturing with direct experience in solid oral dosage.
  • Experience with a small virtual company; Quality Control experience is a plus.
  • Strong knowledge of global GxP expectations, QP (Qualified Person) requirements including work with health authorities.
  • 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 high-performance team and cross functional projects including a successful track record working with suppliers and CMOs.
  • Extensive GxP knowledge with early phase drug development through commercialization.
  • 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 through a well-trained workforce, streamlined business processes and appropriately structured quality operations.
  • 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.

The base salary range for this role is $228,300 to $288,800 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.

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.

US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.

To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

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