Manager Quality Systems
Job Summary
Johnson & Johnson seeks a Manager, Quality Systems to oversee and enhance escalation and field action processes while ensuring full compliance with global regulatory and corporate requirements.
Key Responsibilities
Lead and manage Issue Escalation RMB and Quality Review Board (QRB) processes.
Coordinate information gathering across sites and stakeholders.
Prepare materials and conduct dry runs.
Document meeting minutes and track action items.
Oversee field corrective actions and regulatory follow-ups.
Support global field action coordinators.
Assist with product issue resolution tied to QRB and CAPA activities.
Ensure compliance across all escalation and field action activities.
Prepare documentation for reportable and recordable field actions.
Track customer communications for effectiveness.
Submit interim status reports to the FDAM.
Maintain recall files (electronic and hard copy).
Prepare monthly reports for leadership.
Drive process improvement initiatives and strategic programs.
Monitor Quality Management System (QMS) performance through metrics and analytics.
Identify trends and implement corrective actions.
Ensure team compliance with applicable regulations.
Prepare documentation for reportable and recordable field actions.
Track customer communications for effectiveness.
Submit interim status reports to the FDAM.
Maintain recall files (electronic and hard copy).
Prepare monthly reports for leadership.
Drive process improvement initiatives and strategic programs.
Monitor Quality Management System (QMS) performance through metrics and analytics.
Identify trends and implement corrective actions.
Ensure team compliance with applicable regulations.
Provide leadership and oversight for cross-functional processes and platforms.
Develop and maintain training and knowledge standards.
Identify opportunities to strengthen QMS processes and compliance.
Qualifications
Education: Bachelor’s degree (or equivalent) required; preferred focus in Science, Engineering, or Business.
Skills & Capabilities: Minimum of 6 years of experience in Quality, Regulatory, Supplier Quality, or a regulated industry. Experience owning and executing quality system processes strongly preferred. Demonstrated ability to collaborate cross-functionally and deliver business results. Strong technical writing and documentation skills. Experience supporting health authority or Notified Body inspections preferred.
Preferred Experience: Experience with Corrective and Preventive Action (CAPA), Quality/Incident Management, Quality Management Systems (QMS).
Required Skills
Experience owning and executing quality system processes.
Collaborate cross-functionally and deliver business results.
Strong technical writing and documentation skills.
Experience supporting health authority or Notified Body inspections.
Preferred Skills
Experience with Corrective and Preventive Action (CAPA), Quality/Incident Management, Quality Management Systems (QMS).