Manager/Senior Manager, Quality Assurance, GMP

We are seeking two Manager/Senior Manager, Quality Assurance, GMP candidates to join our team. The selected candidates will work collaboratively with multidisciplinary teams and ensure adherence to GMP regulations and regulatory requirements in support of Xenon’s clinical development programs (all phases) and NDA preparation.  One position will be more focused on Drug Substance, and the other on Finished Goods; Drug Product knowledge and experience is an asset.

Both positions will be based in Vancouver, BC, Canada. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. This role is a hybrid position for Vancouver-based candidates, requiring a minimum of 2 days per week in the office.

RESPONSIBILITIES:

• Contribute to the management of Xenon's Quality Assurance 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.
• Provide support for critical activities and milestones of the CDMO life cycle: qualification and selection, technology transfer and decommission.
• Review documentation supporting active pharmaceutical ingredient (API), drug product and finished product release, including but not limited to master and executed batch records, deviations, investigations, change controls and CAPAs, and analytical data.
• Facilitate and resolve quality issues with CDMOs and internal stakeholders; ensure that API/drug product/finished products meet all required quality standards and specifications.
• Provide support during product release process in various jurisdictions (e.g. EU, UK, USA).
• Provide support into Xenon’s CAPA and quality risk management systems to enable the timely identification and communication of compliance risk.
• Compile and evaluate quality metrics and trends for timely identification, resolution, and communication of compliance risks and to foster continual process improvement initiatives.
• 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.
• Develop and manage audit plan for Xenon’s GMP CDMOs and ensure timely reporting of any trends or risk to Xenon’s QMS. Maintain CDMO site readiness for Health Authority regulatory inspections.
• Some domestic and/or international travel may be required.
• Other duties as assigned.

QUALIFICATIONS:

• Bachelor of Science-in related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• 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 (manufacturing, labeling, packaging, distribution) and the interdependencies between QA and other functional areas.  Previous experience with drug product manufacturing labeling, packaging and distribution or in supporting early phase API development and/or chemical synthesis 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.
•  Capable to participate and conduct quality audits and collaborate with auditees to develop CAPA plans, address root causes and mitigate 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 $113,700 to $153,500 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.