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Senior CAPA FDA Lead

Job Location:

Bothell, WA - USA

Monthly Salary: Not provided by the employer

Posted: 19 May 2026 (30+ days ago)

Application Deadline: 16 August 2026

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Position: Senior CAPA FDA Lead
Location: Bothell Washington Job Description Key Responsibilities

Lead FDA audit and inspection readiness activities across the organization.
Serve as the primary presenter and point of contact during FDA inspections audits and regulatory meetings.
Present CAPA effectiveness investigation quality risk assessments and Health Hazard Evaluation (HHE) processes during FDA interactions.
Review improve and maintain CAPA systems to ensure compliance effectiveness and sustainability.
Drive Health Hazard Evaluation (HHE) assessments related to product quality issues deviations complaints recalls and field actions.
Conduct root cause investigations and ensure implementation of effective corrective and preventive actions.
Coordinate with cross-functional teams including Quality Regulatory Affairs Manufacturing Engineering Supply Chain and Leadership for audit preparedness.
Perform gap assessments against FDA regulations GMP standards and industry best practices.
Support mock audits inspection simulations and preparation of audit responses.
Ensure timely closure of audit observations remediation plans and compliance commitments.
Mentor teams on FDA expectations documentation practices inspection readiness and root cause analysis methodologies.
Prepare and review regulatory responses including FDA 483 responses and associated corrective action plans.

Required Experience

10 years of experience in Quality Compliance Regulatory Affairs or related functions within Pharma Medical Devices Biotechnology or Healthcare industries.
Strong hands-on experience in:
- CAPA Management Systems
- FDA Inspection & Audit Management
- Root Cause Analysis & Investigations
- Health Hazard Evaluation (HHE)
- Regulatory Compliance Programs
- Risk Assessment & Mitigation
Prior experience leading or presenting during FDA inspections with successful outcomes.
Experience handling regulatory escalations audit observations remediation programs recalls and field actions.
Strong knowledge of FDA regulations GMP QMS and compliance standards.
Experience working in cross-functional and high-pressure audit environments.

Preferred Qualifications

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

Key Skills