Director, Site Head of Quality Assurance

Site Head Of Quality Assurance

As the Site Head of Quality Assurance, you will report to the VP of Quality and Regulatory Affairs. The role is responsible for leading and managing all QA functions at the Cincinnati site to ensure compliance with regulatory standards, internal quality policies, and customer expectations. This role plays a critical leadership function in establishing and maintaining a robust Quality Management System (QMS), driving continuous improvement, and supporting regulatory inspections and client audits.

Key Job Responsibilities :

• Lead the Quality Assurance function across the manufacturing site with a focus on compliance, operational excellence, and customer satisfaction.
• Develop and implement QA strategies aligned with corporate quality objectives and regulatory expectations.
• Provide effective oversight of critical quality systems. Ensure timely completion of GMP staff training, thorough deviation / OOS investigations leading to root cause identification and effective CAPA, implementation of timely and effective changes, on-time material / in-process control / product testing, and lot disposition.
• Develop and present in site Quality Council and QMR quality metrics to monitor and analyze key parameters for quality compliance, operational quality, and continuous improvement.
• Act as a quality representative on the site's leadership team and contribute to cross-functional decision-making.
• Ensure site adherence to ICH, and global regulatory cGMP requirements (FDA, EMA, MHRA, etc.).
• Maintain readiness for inspections. Serve as the primary QA contact for regulatory inspections and client audits. Lead audit responses and CAPA implementation.
• Oversee supplier management, internal audit, Gemba Walk program, and Manufacturing QA activities to ensure site compliance.
• Collaborate with clients on QA-related matters, including product quality, audits, quality agreements, and investigations.
• Build and maintain strong relationships with client quality counterparts.
• Lead, mentor, and develop the QA team to ensure capability, performance, and career growth.
• Foster a quality culture that emphasizes integrity, compliance, collaboration, and continuous improvement.

Required Skills / Abilities :

The annualized salary range for this position is $171,800.00 - $210,100.00.