Sr Quality Manager, QMS

Becton Dickinson; El Paso (TX); On-site; USD 110,000 - 170,000; Full time

Job summary

BD is seeking a Quality Governance Leader to own the NCI, CAPA, and Change Control programs at the El Paso site. You will drive data-driven improvements ensuring regulatory compliance and robust quality-system performance across products.

You will lead cross-functional teams, set accountability, and partner with QA, Regulatory, and operations to close gaps and accelerate effective corrective actions. A strong background in FDA guidelines and 21 CFR is expected.

Qualifications

• Experience leading quality governance programs and ensuring regulatory compliance.
• Strong ability to drive investigations, data-driven decision making, and risk assessment.

Responsibilities

• Own and continuously improve the site NCI process, including intake, classification, containment, investigation, root cause determination, product-impact assessment, approval, and closure.
• Lead CAPA initiation, risk-based prioritization, action planning, implementation, verification of effectiveness, and closure.
• Own the Change Control governance from proposal to closure with cross-functional collaboration.
• Define, monitor, and report leading and lagging quality metrics for NCI, CAPA, and Change Control.
• Lead and coach QA personnel responsible for investigations, CAPA, and Change Control.

Skills

Quality governance

Investigations leadership

CAPA management

Change control

Education

Bachelor's degree

Job description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Responsibilities

NCI Governance and Investigation Excellence

• Own and continuously improve the site NCI process, including intake, classification, containment, investigation, root cause determination, product-impact assessment, approval, and closure.
• Ensure investigations are scientifically sound, evidence-based, appropriately scoped, and completed within established timelines.
• Provide Quality oversight for immediate corrections, containment, risk assessments, lot disposition, and escalation of significant or potentially reportable events.
• Ensure laboratory OOS and OOT results are investigated in line with FDA OOS guidance and 21 CFR 211.192, and that events are evaluated promptly for Field Alert Report reportability under 21 CFR 314.81(b)(1).
• Establish standards for investigation tools, causal analysis, human-error evaluation, documentation quality, and recurrence prevention.
• Trend NCI data to identify repeat events, systemic failure modes, emerging signals, and opportunities for preventive action.

CAPA System Leadership

• Lead site governance for CAPA initiation, risk-based prioritization, action planning, implementation, extension management, verification of effectiveness, and closure.
• Ensure CAPAs address verified root causes, include measurable deliverables, define accountable owners and due dates, and are sustainable across affected processes and products.
• Chair the site CAPA Review Board, challenge weak actions, elevate aging or high-risk records, and drive timely removal of barriers to execution.
• Ensure effectiveness checks use objective acceptance criteria, appropriate monitoring periods, and sufficient evidence to demonstrate recurrence control.
• Assess CAPA trends and systemic effectiveness, including recurrence, overdue actions, extensions, and cross-site or cross-functional applicability.

Change Control Governance

• Own and enhance the site Change Control process from proposal and impact assessment through approval, implementation, effectiveness verification, and closure.
• Ensure changes are evaluated for impact to product quality, patient/user safety, regulatory filings, validated state, facilities, equipment, computerized systems, procedures, training, suppliers, and business continuity.
• Partner with Regulatory Affairs to determine regulatory reportability of changes (Prior Approval Supplement, CBE-30, CBE-0, or Annual Report) under 21 CFR 314.70 and ICH Q12, and ensure no change is implemented before required regulatory approval.
• Ensure implementation plans identify prerequisites, testing, validation, documentation, training, regulatory actions, and post-implementation monitoring before the change becomes effective.
• Lead cross-functional change review forums and ensure changes are properly classified, approved by required functions, implemented as authorized, and closed with objective evidence.

Quality System Performance and Compliance

• Define and monitor leading and lagging metrics for NCI, CAPA, and Change Control, including timeliness, aging, recurrence, right-first-time quality, effectiveness, and implementation performance.
• Use data-driven analysis and quality risk management to identify systemic gaps, prioritize remediation, and communicate quality-system health to site leadership and management review.
• Serve as the site Subject Matter Expert for NCI, CAPA, and Change Control during internal audits, regulatory inspections, and responses to observations or commitments, including execution of CAPAs tied to Form FDA 483 observations and Warning Letter remediation.
• Maintain procedures, workflows, training, role clarity, and governance mechanisms that support consistent and sustainable execution.
• Work directly with the Pharma COE QMS Director to align site NCI, CAPA, and Change Control processes with COE and enterprise QMS standards; accelerate systemic issues; implement COE-led harmonization and process improvements; and share lessons learned across Pharma COE sites.

Leadership and Cross-Functional Execution

• Lead, coach, and develop Quality personnel responsible for investigations, CAPA, and Change Control.
• Establish clear accountability, decision rights, escalation pathways, and execution discipline across record owners and approvers.
• Partner with functional leaders to ensure adequate resources, technical expertise, and timely completion of high-risk quality-system activities.
• Foster a culture of transparency, rigorous problem solving, proactive risk reduction, and continuous improvement.

Education and Experience

Education:

Bachelo