Quality Systems Manager

About This Role

This managerial role leads and continuously improves the Quality Management System (QMS) at Johnson & Johnson. It involves strategic ownership of quality systems like eQMS, CAPA, change control, and document control, alongside operational oversight of compliance, audits, supplier quality, and product release. The position suits a systems thinker who collaborates cross-functionally to reduce risk, enhance product and process robustness, and cultivate a culture of quality.

Responsibilities

• Own, maintain, and continuously improve the Quality Management System to meet internal requirements and applicable regulatory standards (e.g., ISO 9001, ISO 13485, 21 CFR Part 820, GMP, or industry-specific standards as relevant)
• Lead the administration and optimization of digital QMS tools: document management, CAPA, nonconformance, change control, training, audit management, and supplier quality modules
• Manage CAPA lifecycle: root cause analysis, corrective actions, validation of effectiveness, and closure with evidence-based controls
• Oversee product release, lot disposition, and quality review processes; ensure timely and compliant product commercialization
• Lead supplier quality activities: qualification, monitoring, performance metrics, and remediation plans
• Drive change control and risk management processes; perform or review risk assessments (e.g., FMEA, risk registers) and ensure mitigation actions are implemented
• Establish and report meaningful quality KPIs and dashboards (e.g., CAPA cycle time, audit findings trend, supplier PPM, customer complaints, deviation rates)
• Provide leadership, coaching, and training on QA processes and QMS usage to cross-functional teams
• Maintain document control: policies, SOPs, batch records, specifications, and quality records with current revision control

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field; advanced degree preferred. For Pharmaceutical: Chemist-Biologist, Pharmaceutical Engineer or Industrial Pharmaceutical Chemist
• 8+ years of progressive quality systems experience; or 5+ years in a managerial role (medical devices, pharma, biotech, CPG, manufacturing)
• Business English proficiency
• Leadership: ability to influence without authority; coach teams to adopt quality practices
• Communication: clear written and verbal communication for technical and non-technical audiences; able to write concise CAPA reports and audit responses
• Project management: ability to manage multiple projects, prioritize, and meet deadlines
• Attention to detail and organizational discipline
• Problem solving: structured and evidence-based approach to troubleshooting and preventive action

Nice to have: