About the role
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