CAPA Lead

Job Description

Responsibilities include but are not limited to:

CAPA Management & Governance

• Own and manage the site CAPA program lifecycle, including initiation, investigation, action planning, implementation, and closure.
• Ensure CAPAs are risk-based, timely, and compliant with internal and regulatory requirements.
• Monitor CAPA effectiveness checks to ensure long-term issue resolution.
• Lead CAPA review boards / governance forums.

Investigations & Root Cause Analysis

• Drive robust problem-solving methodologies (e.g., 5 Whys, Fishbone, Fault Tree, DMAIC).
• Ensure high-quality root cause identification aligned with data and evidence.
• Partner with cross-functional teams (Operations, Quality, Engineering, EHS) to resolve issues.

Compliance & Audit Readiness

• Ensure CAPA processes meet FDA (21 CFR Part 820/210/211 as applicable) and GMP expectations.
• Support regulatory inspections, internal audits, and corporate audits.
• Act as SME for CAPA during audits and inspections.
• Track and report CAPA metrics tied to Warning Letter commitments (if applicable).

Performance Management & Metrics

• Develop and manage CAPA KPIs, including:
• On-time closure rate
• Overdue CAPAs
• Recurrence rate
• Investigation cycle time
• Provide regular reporting to site leadership and corporate teams.
• Identify trends and drive systemic improvements.

Continuous Improvement

• Champion a proactive quality culture focused on prevention vs. correction.
• Integrate CAPA learnings into Lean / BD Excellence initiatives.
• Lead Kaizen or problem-solving events tied to recurring issues.

Training & Capability Building

Train site personnel on:

• CAPA process and expectations
• Root cause analysis tools
• Investigation best practices
• Ensure consistent quality and standardization of investigations across the site.

Education:

• Bachelor's degree in Engineering, Quality or related field.

Experience:

• 5+ years of experience in Quality/Manufacturing within a regulated industry (medical device, pharma, or similar)
• 2+ years in CAPA, investigations, or compliance leadership roles.

Knowledge and Skills

• Fully Bilingual
  - English
  - Spanish
• Strong knowledge of FDA regulations and GMP standards and CAPA systems and quality management systems (QMS)
• Experience with Root cause analysis methodologies, Audit/inspection readiness, Data analysis and trend identification
• Strong cross-functional leadership and influence skills
• Ability to operate in high-pressure, compliance-driven environments
• Excellent communication and executive reporting skills
• Results-driven with strong sense of urgency and accountability