Senior CAPA FDA Lead

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

Senior CAPA FDA Lead

Location: Bothell, Washington

Visa: Any Visa

Position type: C2C Contract

Key Responsibilities

• Lead FDA audit and inspection readiness activities across the business.
• Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes during FDA interactions.
• Act as the primary presenter/interface for FDA inspections, regulatory meetings, and compliance discussions.
• Review and strengthen CAPA systems to ensure regulatory compliance, effectiveness, and sustainability.
• Drive Health Hazard Evaluation (HHE) assessments for product quality issues, complaints, deviations, recalls, and field actions.
• Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness.
• Conduct gap assessments against FDA expectations and industry best practices.
• Support mock audits, inspection simulations, and response preparation activities.
• Ensure timely closure of audit observations, commitments, and remediation plans.
• Mentor teams on FDA expectations, documentation standards, root‑cause analysis, and inspection behavior.
• Support preparation and review of regulatory responses, including 483 responses and associated action plans where applicable.

Required Experience

• 10+ years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries such as Pharma, Medical Devices, Biotechnology, or Healthcare.
• Strong hands‑on experience in:
  • CAPA management systems
  • Root‑cause investigations
  • Health Hazard Evaluation (HHE)
  • FDA audit/inspection management
  • Regulatory compliance programs
• Prior experience leading or presenting during FDA inspections/audits with successful outcomes.
• Demonstrated experience handling regulatory escalations, observations, and remediation programs.
• Strong understanding of FDA regulations, GMP, QMS, risk management, and compliance expectations.
• Experience working in cross‑functional and high‑pressure audit environments.

Preferred Qualifications

• Experience handling FDA inspections involving critical observations or remediation programs.
• Exposure to recalls, field actions, complaint handling, and product risk evaluations.
• Certifications in Quality or Regulatory disciplines.
• Strong executive communication and stakeholder management skills.

Key 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