About the Role
The individual in this role will be responsible for managing quality across the supplier base by conducting assessments, reviewing data, and ensuring adherence to regulatory requirements.
Responsibilities
- Conduct supplier audits to evaluate compliance with quality systems
- Review and approve supplier documentation including certificates of analysis
- Monitor supplier performance metrics and drive corrective actions
- Assist in qualification and approval of new raw material suppliers
- Evaluate supplier change notifications for quality impact
- Support investigations related to supplier-generated non-conformances
- Maintain accurate records of supplier quality activities
- Collaborate with procurement and technical teams on supplier issues
- Ensure suppliers meet applicable regulatory and cGMP standards
- Track and report on key supplier quality indicators
- Participate in risk assessments for critical supply chain components
- Review supplier test methods and validation data
- Support onboarding of suppliers through quality agreements
- Identify opportunities for process improvements in supplier oversight
- Respond to quality-related queries from internal departments
- Assist in preparing for regulatory inspections involving suppliers
- Maintain up-to-date knowledge of industry quality standards
- Escalate critical quality concerns to management promptly
- Contribute to continuous improvement initiatives in supplier quality
- Ensure timely closure of audit findings and CAPAs
Compensation
Competitive salary and benefits package offered
Work Arrangement
On-site position with limited remote flexibility
Team
Part of the Quality Assurance team supporting supply chain integrity
Why Join Us
- Be part of a growing organization focused on advancing gene therapy manufacturing
- Work in a collaborative environment that values innovation and precision
- Contribute directly to product quality and patient safety outcomes
Physical Requirements
- Ability to sit or stand for extended periods while working at a desk
- Occasional lifting of up to 15 pounds may be required
Sponsorship available for qualified candidates
