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XI
Associate Director, Quality Assurance, GMP
Posted 4 months ago
About the role
- Associate Director, Quality Assurance, GMP at Xenon Pharmaceuticals, ensuring GMP compliance and supporting late-stage clinical development. Collaborating with multidisciplinary teams and leading quality systems management.
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.
Requirements
- Bachelor’s degree in life sciences with approx. 8+ years of management and Quality Assurance experience, or comparable background of relevant QA experience in drug development in the bio-tech or pharmaceutical 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, including PPQ 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.
Benefits
- medical
- dental
- vision
- short-& long-term disability
- accidental death & dismemberment
- life insurance programs
- Employee Assistance Program
- travel insurance
- retirement savings programs with company matching contributions
- vacation
- personal days
- sick days
- end-of-year company shutdown
- Tuition Assistance program for advanced degrees
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