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Director, Quality Assurance – GMP
Xenon Pharmaceuticals Inc.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.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMPGxPquality system metricsclinical productsbatch reviewsquality documentssmall molecule manufacturingQP requirements
Soft Skills
leadershipcoachinginterpersonal skillscommunicationorganizational skillsmultitaskingquality mindset
Certifications
Bachelor’s degree in life sciences