CAPA Process Remediation Leader Contractor

Responsibilities:

• CAPA Leadership & Execution:
• Lead, manage, and oversee the full CAPA lifecycle, ensuring timely, compliant, and effective closure of CAPA investigations.
• Drive root cause investigations using structured methodologies (e.g., 5-Why, Fishbone, Fault Tree Analysis).
• Ensure CAPA documentation meets all regulatory and internal standards.
• Process Harmonization Across Sites:
• Assess and analyze existing CAPA processes across three sites operating under two distinct QMSs.
• Develop and implement a standardized, site-integrated CAPA process to support alignment and consistency.
• Collaborate closely with cross-functional teams (Quality Engineering, Operations, QA, RA, Manufacturing) to ensure adoption and sustainability.
• Compliance & Regulatory Remediation:
• Support quality system improvements tied to FDA 483 observations and Consent Decree commitments.
• Ensure updated processes meet all FDA, ISO 13485, and internal compliance requirements.
• Prepare documentation, metrics, and summaries for leadership reviews and potential FDA interactions.
• Continuous Improvement:
• Identify systemic issues and drive proactive quality and compliance enhancements.
• Develop training materials and provide coaching to staff on CAPA best practices and updated processes.
• Monitor CAPA effectiveness metrics and support ongoing audits and system health checks.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field.
• 5+ years of experience in CAPA leadership within the medical device, pharmaceutical, or biotech industry.
• Strong knowledge of FDA regulations, 21 CFR 820 and ISO 13485.
• Prior experience supporting FDA 483s, Warning Letters, or Consent Decree remediation strongly preferred.
• Demonstrated success leading cross-site or multi-system process harmonization projects.
• Excellent communication, documentation, and stakeholder management skills.
• Must be local to the Wayne, NJ area and able to work onsite.