Sr Quality Manager, QMS

Becton Dickinson Medical Devices•El Paso, TX

5d•Onsite

About The Position

The Sr Quality Manager, QMS leads site governance and continuous improvement for Nonconformance Investigation (NCI), Corrective and Preventive Action (CAPA), and Change Control processes in a regulated manufacturing environment. The role ensures quality records are risk-based, evidence-based, compliant, timely, and effective, and that systemic issues are identified, addressed, and communicated to site leadership. It serves as the site subject matter expert for these quality systems during audits and regulatory inspections, while aligning site processes with Pharma COE and enterprise QMS standards. The position also leads and develops Quality personnel and drives cross-functional accountability, transparency, and continuous improvement.

Requirements

Bachelor’s degree in Engineering, Science, Pharmacy, or a related technical discipline.
Minimum of 10 years of Quality experience in pharmaceutical and/or medical device manufacturing.
Minimum of 5 years in leadership roles with direct people-management or quality-system governance responsibility.
Demonstrated experience leading complex investigations, CAPA programs, and Change Control in a regulated manufacturing environment.

Nice To Haves

Master’s degree preferred.
Pharmaceutical experience strongly preferred.
Experience supporting FDA or other regulatory inspections and remediation activities, including responses to Form FDA 483 observations or Warning Letters, preferred.

Responsibilities

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 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 evaluate events 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 preventive-action opportunities.
Lead site CAPA governance, including initiation, risk-based prioritization, action planning, implementation, extension management, effectiveness verification, and closure.
Ensure CAPAs address verified root causes, have measurable deliverables and accountable owners, and are sustainable across affected processes and products.
Chair the site CAPA Review Board, challenge weak actions, escalate aging or high-risk records, and remove execution barriers.
Ensure effectiveness checks use objective acceptance criteria, suitable 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.
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 on 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 under 21 CFR 314.70 and ICH Q12, and ensure changes are not implemented before required regulatory approval.
Ensure change implementation plans identify prerequisites, testing, validation, documentation, training, regulatory actions, and post-implementation monitoring.
Lead cross-functional change review forums and ensure changes are classified, approved by required functions, implemented as authorized, and closed with objective evidence.
Define and monitor leading and lagging NCI, CAPA, and Change Control metrics, including timeliness, aging, recurrence, right-first-time quality, effectiveness, and implementation performance.
Use data analysis and quality risk management to identify systemic gaps, prioritize remediation, and communicate quality-system health to site leadership and management review.
Serve as site subject matter expert for NCI, CAPA, and Change Control during audits, regulatory inspections, and responses to observations or commitments, including CAPAs related 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 with the Pharma COE QMS Director to align site processes with COE and enterprise QMS standards, escalate systemic issues, implement harmonization and process improvements, and share lessons across Pharma COE sites.
Lead, coach, and develop Quality personnel responsible for investigations, CAPA, and Change Control.
Establish 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 transparency, rigorous problem solving, proactive risk reduction, and continuous improvement.