Full Job Description
The Manager, Quality Assurance leads the site's Quality Management System (QMS) and Quality Assurance team, ensuring compliance with PMI, FDA, ISO, and regulatory requirements. This role drives audit and inspection readiness, CAPA oversight, management review, and continuous improvement while developing team capabilities and promoting a strong quality culture. Key Responsibilities
• Lead, coach, and develop Quality Assurance personnel.
• Manage performance, employee development, training, and succession planning.
• Lead and maintain the site Quality Management System.
• Ensure compliance with PMI standards, FDA regulations, ISO requirements, and site procedures.
• Maintain audit and inspection readiness and support regulatory inspections.
• Lead internal audits and oversee audit responses and corrective actions.
• Manage Management Review activities and key quality performance indicators.
• Oversee deviations, investigations, non-conformances, and CAPA programs.
• Drive root cause analysis, risk management, and continuous improvement initiatives.
• Provide QA leadership for site projects, strategic initiatives, and change management activities.
What we are looking for:
• Bachelor's or Master's degree in Biological Sciences, Physical Sciences, Engineering, Pharmacy, Chemistry, or a related field, or equivalent regulated-industry experience.
• 5+ years of Quality Assurance, Quality Systems, or related experience in a regulated manufacturing environment.
• Proven leadership experience managing teams in a regulated environment.
• Experience with audits, inspections, CAPA systems, management reviews, and compliance programs.
• Strong knowledge of QMS, FDA and ISO requirements, risk management, CAPA, document control, and training systems.
• Project and change management experience.
• Fluent in English.
Annual Base Salary Range: $132,000 - $165,000
