QMS Manager

Quality Management System (QMS) roles are essential in pharmaceutical manufacturing as companies strengthen compliance, improve sterile production processes, and maintain FDA readiness. This QMS Manager opportunity in Boca Raton focuses on supporting GMP operations within a sterile injectable manufacturing environment, with H-1B visa transfer options available for eligible candidates.

The QMS Manager role focuses on managing and improving quality systems within a GMP-regulated sterile pharmaceutical manufacturing site. The position involves overseeing deviations, CAPAs, change controls, and investigations while ensuring compliance with regulatory standards. The role also includes cross-functional collaboration with manufacturing, QC, and engineering teams to maintain product quality and support audit readiness.

EPM Scientific partners with pharmaceutical and life sciences organisations to support hiring for specialised quality and regulatory roles. The client organisation in this case is a growing sterile pharmaceutical manufacturer expanding its operations in South Florida. The company is focused on strengthening its quality systems infrastructure as it scales production of injectable products under strict regulatory requirements.

• Manage deviations, CAPAs, change controls, and quality investigations.
• Drive continuous improvement of the site Quality Management System.
• Collaborate with manufacturing, quality control, and engineering teams to resolve quality issues.
• Support batch record review and product release processes.
• Maintain and manage QMS documentation using systems such as Track Wise or Veeva.
• Support preparation for internal and external audits and regulatory inspections.
• Ensure compliance with GMP requirements and data integrity standards.
• Monitor and improve quality processes across sterile manufacturing operations.
• Contribute to inspection readiness and regulatory compliance initiatives.
• Support cross-functional quality decision-making within production environments.

• Experience in Quality Assurance within a GMP-regulated pharmaceutical environment.
• Strong experience managing deviations, CAPAs, and investigations.
• Experience working in pharmaceutical manufacturing or production environments.
• Understanding of GMP regulations, documentation standards, and data integrity principles.
• Ability to collaborate effectively with cross-functional technical and operational teams.
• Experience supporting batch review and product release activities.
• Familiarity with QMS platforms such as Track Wise, Veeva, or equivalent systems.
• Strong analytical and problem-solving skills in quality-related decision-making.
• Experience working in regulated environments with strict compliance standards.

This QMS Manager role offers strong exposure to sterile pharmaceutical manufacturing and GMP quality systems within a growing production environment. With responsibility across core QMS functions and involvement in regulatory readiness activities, the position provides a solid pathway for professionals seeking leadership roles in pharmaceutical quality assurance in the United States.