CAPA Program Lead

Katalyst CRO; New Jersey; On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst CRO seeks an experienced CAPA Program Lead to steer a high‑priority quality remediation initiative for medical devices. You will assess existing CAPA and quality systems, identify regulatory gaps related to raw materials and components, and develop actionable remediation plans with cross‑functional teams.

This role requires strong program management, risk assessment, stakeholder communications, and delivering audit‑ready documentation to support regulatory compliance across global sites.

Qualifications

• BS degree in Life Sciences or related discipline.
• Extensive CAPA and regulatory remediation experience in medical devices.
• Strong knowledge of QMS, CAPA, root cause analysis, risk management, supplier quality, and quality documentation.
• Experience leading cross‑functional, international programs.
• Experience with regulatory requirements for Class III devices.

Responsibilities

• Lead CAPA and quality remediation program from assessment through implementation.
• Evaluate processes, supplier controls, and quality systems to identify gaps.
• Develop remediation plans with timelines, milestones, and risk management.
• Collaborate with Quality, Regulatory, R&D, Manufacturing, and global stakeholders.
• Provide executive‑level status reporting and ensure audit readiness.

Skills

CAPA Management

Regulatory remediation

Quality systems

Program management

Cross-functional leadership

Root cause analysis

Risk management

Supplier quality

Communication

Education

BS in Life Sciences

Job description

Summary

Our client is a leading medical device company and is seeking an experienced CAPA Program Lead to lead a high‑priority quality remediation initiative supporting medical device regulatory compliance. This consultant will assess existing quality processes, identify compliance gaps related to raw materials and components, develop and execute remediation plans, and partner with cross‑functional teams to implement sustainable process improvements. This is an ideal opportunity for a seasoned medical device quality professional who combines deep CAPA expertise and regulatory knowledge with strong program management capabilities.

Roles & Responsibilities

• Lead a complex CAPA and quality remediation program, driving activities from assessment through implementation.
• Evaluate existing processes, documentation, supplier controls, and quality systems to identify compliance gaps and root causes.
• Develop and execute remediation plans, including project timelines, milestones, risk management, and cross‑functional action plans.
• Partner with Quality, Regulatory, R&D, Manufacturing, Procurement, and global stakeholders to drive alignment and accountability.
• Facilitate recurring project meetings, monitor progress, manage risks, and provide executive‑level status reporting.
• Support development and revision of quality system documentation, procedures, and training materials to ensure regulatory compliance.
• Drive implementation of corrective and preventive actions, including supplier quality improvements, process enhancements, and verification activities.
• Ensure remediation activities and supporting documentation are inspection‑ and audit‑ready while establishing sustainable long‑term processes.

Requirements

• BS degree in Life Sciences or related discipline.
• Extensive experience leading CAPA, regulatory remediation, or quality system improvement initiatives within the medical device industry.
• Strong knowledge of medical device Quality Management Systems, CAPA processes, root cause analysis, risk management, supplier quality, and quality documentation.
• Demonstrated program/project management experience leading complex, cross‑functional initiatives across global organizations.
• Experience supporting supplier controls, raw material/component documentation, and regulated manufacturing environments.
• Excellent communication, facilitation, and stakeholder management skills.
• Ability to work effectively across international teams and support meetings aligned with Japan time zones.
• Experience supporting Japan medical device regulatory requirements and quality documentation expectations.
• Experience with Class III and/or cardiovascular medical devices.
• Familiarity with global regulatory remediation programs and audit readiness.