Pennsylvania Licensed Quality Director

Job Summary

Leading the strategic and operational aspects of Quality Assurance, the full-time Pennsylvania Licensed Quality Director will oversee compliance, validation, and quality control in sterile injectable manufacturing while mentoring staff and driving cross-functional collaborations in York, Pennsylvania.

Key responsibilities

• Provide strategic leadership and oversight of all cGMP-regulated areas, ensuring compliance with FDA, EMA, and international standards
• Manage quality assurance and validation activities, mentoring junior staff and ensuring readiness for regulatory inspections
• Support Business Development initiatives and lead validation projects, driving quality improvements and compliance across departments

Required qualifications

• Bachelor's degree or higher in life sciences, engineering, or a related technical field; advanced degree preferred
• Minimum of 15 years of experience in pharmaceutical quality assurance, with at least 5 years in a leadership role
• Extensive experience in cleanroom operations and cGMP environments
• Proven track record in regulatory compliance and quality assurance within pharmaceutical or biotech industries
• Strong independent judgment and decision-making capabilities, with experience leading cross-functional teams