Site Quality Director
AstraZeneca · Longwood Road South, Canada
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Fusion Pharmaceuticals, an AstraZeneca subsidiary, seeks a Site Quality Director to lead quality assurance and compliance operations at its Hamilton radiopharmaceutical facility. The role oversees product safety, cGMP compliance, regulatory readiness, and quality culture while managing direct reports and cross-functional initiatives.
What they're looking for
- Bachelor's degree in chemistry, pharmacy, engineering, or life science; advanced degree preferred
- Minimum 15 years pharmaceutical quality management experience with 5+ years in leadership
- Significant experience in radioconjugate manufacturing and batch record/material release review
- Deep knowledge of USFDA 21 CFR Part 11, GMP, ICH guidelines, and Health Canada regulations
- Proven ability to lead, motivate, and develop teams with diverse skill sets
- Strong organizational, communication, and written documentation skills
- On-site availability in Hamilton with flexibility for off-shift and weekend support
What you'll be doing
- Ensure finished products meet cGMP requirements, regulatory commitments, and company policies
- Establish site quality goals, objectives, and strategic direction aligned with global standards
- Track quality metrics, oversee QA/QC compliance activities, and drive corrective/preventive actions
- Manage quality processes, operations, systems, and continuous improvement initiatives for efficiency gains
- Coach, develop, and evaluate direct and indirect reports through feedback and performance management
Privacy & handoff
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