Senior Quality Leader – NCI, CAPA & Change Control

BD; El Paso (TX); On-site; USD 140,000 - 200,000; Full time

Job summary

BD is seeking a Senior Quality governance leader at the USA TX El Paso site to drive NCI, CAPA, and Change Control governance. You will lead investigations, ensure regulatory alignment, and oversee corrective actions to sustain product quality and safety.

The role requires 10+ years in pharmaceutical/medical device quality with 5+ years in leadership, experience with FDA inspections, and a strong track record in driving process improvements across cross-functional teams.

Qualifications

• Bachelor’s degree required in a technical discipline; Master’s preferred.
• 10+ years of Quality experience in pharma/medical device manufacturing.
• 5+ years in leadership roles with people-management or governance responsibility.
• Experience leading complex investigations, CAPA programs, and Change Control in a regulated environment.
• Experience supporting FDA or regulatory inspections and remediation activities.

Responsibilities

• Own and continuously improve the site NCI process: intake, classification, containment, investigation, root cause, product-impact assessment, approval and closure.
• Provide QA oversight for corrections, containment, risk assessments, lot disposition, and escalation of reportable events.
• Ensure lab OOS/OOT investigations align with FDA guidance and 21 CFR rules; evaluate events for reportability.
• Establish standards for investigation tools, causal analysis, human-error evaluation, documentation quality, and recurrence prevention.
• Lead CAPA initiation, risk-based prioritization, action planning, implementation, verification of effectiveness and closure.
• Chair the CAPA Review Board and drive timely removal of barriers to execution.
• Own the Change Control process: proposal, impact assessment, approval, implementation, verification and closure.
• Ensure changes affect product quality, safety, regulatory filings, validated state, facilities and training.
• Lead cross-functional change review forums with proper classification and evidence-based closure.
• Define leading/lagging metrics for NCI, CAPA, Change Control; monitor performance and communicate health to leadership.

Skills

Quality leadership

Investigations

CAPA

Change Control

Education

Bachelor’s degree in Engineering, Science, Pharmacy, or related technical discipline

Master’s degree preferred

Job description

BD is seeking a Senior Quality governance leader at the USA TX El Paso site to drive NCI, CAPA, and Change Control governance. You will lead investigations, ensure regulatory alignment, and oversee corrective actions to sustain product quality and safety.

The role requires 10+ years in pharmaceutical/medical device quality with 5+ years in leadership, experience with FDA inspections, and a strong track record in driving process improvements across cross-functional teams.