What are the responsibilities and job description for the Compliance Manager position at InfoStride?
Senior CAPA FDA Lead – Bothell, WA (Any Visa | C2C)
Seeking an experienced Senior CAPA FDA Lead with 10 years of experience in Quality, Compliance, Regulatory Affairs, or Quality Systems within Pharma, Medical Device, Biotechnology, or Healthcare industries.
Key Responsibilities:
- Lead FDA inspection readiness and audit activities.
- Serve as the primary presenter/interface during FDA inspections and regulatory meetings.
- Drive CAPA effectiveness, root cause investigations, risk assessments, and Health Hazard Evaluations (HHE).
- Support FDA responses, remediation programs, audit observations, recalls, and field actions.
- Partner with Quality, Regulatory, Manufacturing, Engineering, and Leadership teams to ensure compliance and inspection preparedness.
Required Skills:
- FDA Inspection Readiness & Audit Management
- CAPA Management & Effectiveness
- Health Hazard Evaluation (HHE)
- Root Cause Analysis & Risk Assessment
- GMP, QMS, and Regulatory Compliance
- FDA 483 Response & Remediation Experience
- Strong stakeholder management and communication skills
Location: Bothell, WA