Packaging Quality Lead – GMP & Compliance

Hardware FYI; El Paso (TX); On-site; USD 100,000 - 140,000; Full time

Job summary

BD (Becton, Dickinson, and Company) is seeking a Packaging Operations Quality Oversight professional to join our Texas site. You will provide real-time quality leadership for pharmaceutical packaging lines, ensuring compliance with cGMP, master packaging records, and batch disposition.

The role emphasizes risk-based decision making, CAPA effectiveness, and collaboration with Packaging Operations to drive standard work, training, and process improvements.

Qualifications

• Minimum 5 years of Quality experience in pharmaceutical/medical device manufacturing or packaging.
• Experience with packaging line clearance, printed components and label control, reconciliation, batch record review, deviation investigations, CAPA, change control, and inspection readiness.
• Experience supporting FDA or health-authority inspections is strongly preferred.

Responsibilities

• Provide independent, real-time Quality oversight of pharmaceutical packaging operations and associated controlled areas.
• Ensure packaging activities comply with approved master packaging records, procedures, specifications, validated processes, and applicable cGMP requirements.
• Oversee packaging line setup, line clearance, start-up, changeover, in-process checks, sampling, reconciliation, and line closeout.
• Ensure printed packaging materials, labels, components, bulk product, samples, rejects, returns, and waste are controlled, segregated, reconciled, and traceable.
• Verify coding, overprinting, vision-system challenges, barcode controls, label issuance, and reconciliation controls are executed and documented accurately.
• Drive routine Quality presence on the packaging floor to identify and resolve compliance risks before product impact occurs.
• Ensure packaging documentation is complete, contemporaneous, attributable, accurate, and suitable for batch review and disposition.
• Support timely batch record review, exception resolution, and disposition decisions based on documented evidence and Quality risk management.
• Lead, coach, and develop Quality personnel supporting packaging operations; establish clear roles, decision rights, coverage, and escalation expectations.
• Manage daily Quality priorities, staffing, shift support, workload, and resource deployment based on production needs and compliance risk.
• Partner with Packaging Operations to improve standard work, operator-facing instructions, training effectiveness, error-proofing, and execution discipline.
• Promote a culture of accountability, transparency, timely escalation, and continuous improvement without compromising Quality independence.
• Serve as the Packaging Quality SME during internal audits, regulatory inspections, customer audits, and remediation activities.

Skills

Quality oversight

cGMP knowledge

Root cause analysis

Leadership

Data integrity

Cross-functional influence

FDA inspections

Education

Bachelor's degree in Engineering/Science/Pharmacy/Packaging

Master's degree preferred

Tools

SAP

Vision systems

Electronic quality systems

Job description

BD (Becton, Dickinson, and Company) is seeking a Packaging Operations Quality Oversight professional to join our Texas site. You will provide real-time quality leadership for pharmaceutical packaging lines, ensuring compliance with cGMP, master packaging records, and batch disposition.

The role emphasizes risk-based decision making, CAPA effectiveness, and collaboration with Packaging Operations to drive standard work, training, and process improvements.