Required Qualifications & Experience
• Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or a related discipline.
• Minimum of 15 years of relevant experience, including 10+ years of managerial and people leadership experience.
• Experience leading quality functions within a regulated manufacturing environment.
• Strong understanding of quality management systems, regulatory compliance, risk management, auditing, and continuous improvement methodologies.
• Experience supporting regulatory inspections and audit readiness activities, including FDA inspections and remediation programs.
• Proven ability to lead cross-functional teams and influence stakeholders across Quality, Operations, Engineering, Supply Chain, and Business functions.
• Demonstrated success in building, developing, and leading high-performing teams.
Preferred Qualifications
• Prior site quality leadership experience.
• Experience leading quality across multiple manufacturing sites, geographies, or regions.
• Experience within the medical device, pharmaceutical, biotechnology, or other highly regulated industries.
• Experience assessing organizational capability, succession planning, and talent development across multiple locations.
• Demonstrated ability to drive quality culture transformation and operational excellence initiatives.