Role: Associate Director of Quality overseeing site compliance within a biopharma manufacturing environment, with a focus on maintaining regulatory standards and continuous quality improvement.
Responsibilities
- Provide quality direction
- Manage documentation
- Conduct audits
- Ensure GMP compliance
- Lead quality systems including change control
- Supervise Quality Specialists partnering with operations teams
Requirements
- Bachelor's in science or engineering with 8+ years of relevant experience
- Strong knowledge of cGMP, FDA, and EMEA regulations
- At least 2 years in GMP-controlled environments
Preferred
- Leadership of teams
- Experience with aseptic/sterile processing
- Lean principles (LSS Green Belt)
- Biologics or vaccine manufacturing experience
High-Value
- Biologics or vaccine production
- GMP compliance
- Quality management systems
- Regulatory audits
- Risk and deviation management
- Cross-functional collaboration
- 10% travel
Work Setup
On-site, with travel as needed.
#J-18808-LjbffrAssociate Director Quality in pa at Unknown Company
This position is listed as full time and onsite.