Quality Systems Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function
Quality

Job Sub Function
Quality Systems

Job Category
People Leader

Job Description
Position Summary
Quality Assurance / Quality Systems Manager lead and continuously improve the Quality Management System (QMS). This role combines strategic ownership of quality systems (e.g., eQMS, CAPA, change control, document control) with hands-on operational oversight of compliance, audits, supplier quality, and product release activities. The ideal candidate is a systems thinker who partners cross-functionally to reduce risk, increase product and process robustness, and embed a culture of quality.

Key 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.