Senior Manager, Quality Assurance, GMP

Vancouver, BC, Canada Req #230
Friday, March 8, 2024
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 XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures. In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 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 a Senior Manager, Quality Assurance, GMP to join our team. The Senior Manager, Quality Assurance, GMP will work collaboratively with multidisciplinary teams and ensure adherence to GMP regulations and regulatory requirements in support of Xenon’s late-stage clinical development programs and NDA preparation.

This position reports to the Associate Director, Quality Assurance, GMP and will be in Vancouver, BC, Canada. We will consider the following jurisdictions for exceptional candidates: Ontario, Quebec. The level of the position will be commensurate with the candidate’s education and industry experience. 

RESPONSIBILITIES:

  • Contribute to the management of Xenon’s quality systems and activities including change control, nonconformance and deviation management, complaint and recall management, quality risk management, vendor qualification, audits, GxP training programs, data quality audits, and inspection readiness.
  • Compile and evaluate quality metrics and trends for timely identification, resolution, and communication of compliance risks and to foster continual process improvement initiatives.
  • Manage batch release operations activities, including but not limited to master and executed batch record review, deviations, investigations, change controls and CAPAs review, and analytical data review. 
  • Lead and manage critical activities and milestones of the CDMO life cycle: qualification and selection, technology transfer, management, and decommission.
  • Facilitate and resolve quality issues with CDMOs and internal stakeholders; ensure that products meet all required quality standards and specifications.
  • Maintain CDMO site readiness for Health Authority regulatory inspections.
  • Apply risk-based review processes for GMP documentation by identifying key elements such as critical quality attributes, critical process parameters, and critical material attributes suitable for the phase of development.
  • Contribute to training initiatives and GMP compliance interpretation to support and improve quality processes that assure product quality and data integrity.
  • Participate in on-site regulatory inspections and Xenon audits.
  • Establish and maintain effective working relationships that promotes continuous application of quality principles and compliance with regulatory requirements while remaining independent. Develop strong working relationships with CMC, Quality Control, and Regulatory functions.
  • 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 domestic and/or international travel may be required.
  • Other duties as assigned.

QUALIFICATIONS:

  • A bachelor’s degree from an accredited institution in a scientific or health field with at approx. 5-8 years of QA experience, or comparable background of relevant QA experience in drug development in the biopharmaceutical industry.
  • Strong knowledge and experience with global GMP regulations, principles and guidelines, current industry standards, best practices, and methodologies.
  • Good understanding of the drug development process and the interdependencies between QA and other functional areas.  Previous experience with drug substance or drug product manufacturing is highly desirable.
  • Strong critical thinking and decision-making skills. 
  • Organizational skills and attention to detail to effectively prioritize and manage complex projects within established timelines.
  • Proficient in conducting quality audits and collaborating with auditees to develop CAPA plans, addressing root causes and mitigating risks.
  • Ability to work autonomously and collaboratively as part of a multidisciplinary team.
  • Clear, concise, and professional written and oral communication skills.
  • Experience maintaining an electronic quality management system is beneficial.

The base salary range for this role is $108,439 to $137,143 CAD; 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.

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.