Associate Director Quality Operations
We are looking for a dedicated and experienced Associate Director of Quality Operations to join our GMP-regulated client on the East coast. This on-site role will be pivotal in leading the overall quality strategy, ensuring compliance with regulatory requirements, and driving continuous improvement across quality processes. The successful candidate will provide leadership and direction to Quality Assurance staff and collaborate closely with internal teams to uphold the highest quality standards.
Key Qualifications:
• 8+ years in the pharmaceutical industry
• 5+ years in quality operations
• 6+ years in a commercial manufacturing environment working with cell therapy or biologics
• Experience with FDA inspections
• Bachelor’s degree in a scientific discipline is required.
Key Responsibilities:
• Lead the quality strategy for the asset, ensuring alignment with customer agreements, company policies, and regulations.
• Act as the escalation point for QA team and internal stakeholders.
• Track and report on quality metrics, including deviation trends, for senior leadership.
• Identify and implement process improvements for quality.
• Manage lot release and disposition activities.
This is an outstanding opportunity for an experienced leader in quality operations to further their career within a dynamic and growing organization. If you have a strong track record in driving quality excellence and are ready to lead a high-performing team, we encourage you to apply.
Interested? Apply today to become a key contributor to our client's quality operations team!