Director of Quality Assurance for clinical programs at Xenon Pharmaceuticals. Leading quality initiatives and ensuring compliance across manufacturing and testing operations in the clinical stage.
Responsibilities
Responsible for quality-related matters at a CMO focusing on clinical products
Lead and support external quality activities like batch reviews and release
Collaborate with internal CMC functions ensuring cGMP compliance
Author and review quality documents
Attend CMO and internal team meetings
Support quality system and product review meetings
Represent Quality function on project teams
Promote a quality mindset throughout the organization
Recruit, lead, direct, develop, coach and evaluate direct reports
Act in accordance with Company policies and ensure adherence
Requirements
Bachelor’s degree in a life sciences discipline
10+ years of experience in GMP quality leadership positions
Strong understanding of small molecule manufacturing
Extensive GxP knowledge
Experience with a small virtual company
Strong knowledge of global GxP expectations and QP requirements
Ability to effectively organize and multitask
Extensive experience establishing key quality system metrics
Strong interpersonal skills
Ability to communicate proactively
Benefits
Health insurance
Retirement savings programs with company matching contributions
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