Manager Quality Systems

Job Summary

Johnson & Johnson is seeking a Manager, Quality Systems to lead 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, including:

• Coordinating information gathering across sites and stakeholders
• Preparing materials and conducting dry runs
• Documenting meeting minutes and tracking action items

• Oversee field corrective actions and regulatory follow-ups, including:

• Supporting global field action coordinators
• Aiding in product issue resolution tied to QRB and CAPA activities

• Ensure compliance across all escalation and field action activities by:

• Preparing documentation for reportable and recordable field actions
• Tracking customer communications for effectiveness
• Submitting interim status reports to the FDAM
• Maintaining recall files (electronic and hard copy)
• Preparing monthly reports for leadership

• Drive process improvement initiatives and strategic programs to enhance systems and foster innovation

• Monitor Quality Management System (QMS) performance through metrics and analytics, identifying trends and implementing corrective actions

• Ensure team compliance with applicable regulations, including:

• FDA 21 CFR Parts 820, 210/211, and 4
• ISO 13485
• Global regulatory requirements (e.g., MHLW, ANVISA)

• Develop and maintain training and knowledge standards to ensure personnel are equipped to meet quality expectations

• Act as a subject matter expert (SME), identifying 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)