FDA CAPA Lead: Audit Readiness & Regulatory Strategy

Accord Technologies Inc; Bothell (WA); On-site; USD 110,000 - 130,000; Part time

Job summary

Accord Technologies Inc is seeking a Senior CAPA FDA Lead in Bothell, Washington. The ideal candidate will have over 10 years of experience in Quality, Compliance, or Regulatory roles within regulated industries. Responsibilities include leading FDA audit readiness activities, conducting gap assessments, and mentoring teams on FDA expectations.

The position demands strong hands-on experience with CAPA management systems and regulatory compliance, ensuring effective leadership during inspections and audits.

Qualifications

• 10+ years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries.
• Strong hands-on experience in CAPA management systems.
• Prior experience leading or presenting during FDA inspections/audits.

Responsibilities

• Lead FDA audit and inspection readiness activities across the business.
• Own and present CAPA effectiveness and investigation quality during FDA interactions.
• Conduct gap assessments against FDA expectations.

Skills

FDA Inspection Readiness

CAPA Effectiveness

Health Hazard Evaluation (HHE)

Regulatory Compliance

Root Cause Analysis

Risk Assessment

Audit Presentation & Defense

Quality Systems

Cross-functional Leadership

Executive Communication

Job description

Accord Technologies Inc is seeking a Senior CAPA FDA Lead in Bothell, Washington. The ideal candidate will have over 10 years of experience in Quality, Compliance, or Regulatory roles within regulated industries. Responsibilities include leading FDA audit readiness activities, conducting gap assessments, and mentoring teams on FDA expectations.

The position demands strong hands-on experience with CAPA management systems and regulatory compliance, ensuring effective leadership during inspections and audits.