Intermediate Quality Engineer responsible for quality assurance and automated testing at Manulife. Collaborating with teams to improve software product quality through testing practices and metrics.
About the role
- 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
- Travel insurance
- Employee Assistance Program
- Vacation and personal days
- Sick days
- End-of-year company shutdown
- Tuition Assistance program for advanced degrees
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