Sr Quality Manager - CAPA

The Sr. Manager, CAPA, is responsible for driving overall CAPA management including CAPA process, system improvements, standardization, harmonization, and CAPA transformation across QMSR North America sites (FMCNA), with a primary focus on improving how CAPA is managed in line with NA and global QMSR, Global Management Systems (GMS), and associated operational and business systems. The Sr. Manager leads, engages, demonstrates, advises, and changes CAPA process to demonstrate effective systems and in compliance with all regulatory and quality requirements – while meeting business objectives and performance expectations.

This role focuses on simplification and improving the ways we work both locally and globally. In addition, this role focuses on how regulatory and business processes/systems are working in synch to ensure delivery of effective CAPA solutions to advance the cause of quality and business objectives. The position is responsible for leading the CAPA process, program, and activities across the organization to ensure compliance with global regulatory requirements including FDA Quality System Regulation / QMSR, ISO 13485, and applicable international standards.

This role drives, facilitates, coordinates and escalates as appropriate the investigation and resolution of complex quality issues arising from complaints, nonconformances, audit observations, supplier issues, and post-market surveillance activities related to medical devices and drugs including device-drug combination products as well as digital products. The Sr. CAPA Manager partners closely with cross-functional teams including Engineering, Manufacturing, R&D, Clinical, Regulatory Affairs, and Supplier Quality to ensure timely execution of robust root cause investigations and sustainable corrective actions.

The role also supports regulatory inspections, notified body audits, and global compliance initiatives while continuously improving the effectiveness of the CAPA system.

• Leads and manages the CAPA program and process in accordance with 21 CFR 820 / FDA QMSR, ISO 13485, and global regulatory requirements.
• Provides regular updates to appropriate levels of management regarding overall CAPA performance.
• Ensures proper investigation, documentation, and closure of CAPAs, Nonconformances, and Quality Events.
• Monitors CAPA timelines and effectiveness checks to ensure compliance and sustainability of corrective actions.
• Ensures CAPAs are properly linked to appropriate complaints, audits, risk management files, and supplier quality events.
• Drives process improvements and changes by working collaboratively with leaders, employees, and all stakeholders.
• Evaluates and drives changes on CAPA SOPs, policies, and procedures for measurable improvements.
• Collaborates with employees to drive CAPA education and training of process requirements, improvements, and application.
• Collaborates with employees to address CAPA areas of improvement and speed up the overall performance and execution.
• Leads complex root cause investigations using structured methodologies such as: 8D problem solving, Fishbone (Ishikawa),5 Whys, Fault Tree Analysis, DMAIC and using other tools
• Participates and supports FDA inspections, Notified Body audits, and internal quality audits related to CAPA system effectiveness.
• Prepares CAPA documentation and investigation records for regulatory review.
• Addresses audit observations and drive timely completion of corrective actions.
• Ensures investigations are data-driven, well documented, and meet regulatory expectations.
• Identifies systemic issues through data analysis and trend monitoring.
• Develops improvements to strengthen the CAPA process and overall quality system.
• Drives…