Quality Manager (Packaging)

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.

• 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.

• Ensure packaging deviations, nonconformances, investigations, CAPAs, change controls, complaints, and temporary controls are initiated promptly, scientifically sound, sustainable, and inspection-ready.
• Apply structured root cause analysis and data-driven methods to packaging defects, mix-up risks, reconciliation discrepancies, line-clearance failures, coding errors, and recurring process issues.
• Assess product and compliance impact and escalate significant packaging events, data integrity concerns, or loss of process control in accordance with site procedures.
• Monitor packaging performance indicators and trends, including right-first-time execution, deviations, documentation errors, reconciliation events, line-clearance observations, and CAPA effectiveness.
• Ensure CAPAs include clear ownership, appropriate containment, risk-based corrective actions, defined due dates, and robust verification of effectiveness.
• Serve as the Packaging Quality SME during internal audits, regulatory inspections, customer audits, and remediation activities.

• 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.

Education and Experience:

• Bachelor's degree in Engineering, Science, Pharmacy, Packaging, or a related technical discipline. Master's degree preferred.

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

Knowledge and Skills:

• Working knowledge of pharmaceutical cGMP requirements, including 21 CFR Parts 820, 210 and 211, with practical application to packaging and labeling operations.
• Strong understanding of mix-up prevention, line clearance, status identification, segregation, reconciliation, coding and vision controls, and data integrity.
• Ability to make timely, risk-based Quality decisions in a fast-paced packaging environment while maintaining independence and escalation discipline.
• Demonstrated capability in investigation, root cause analysis, statistical trending, and CAPA effectiveness.
• Strong leadership, coaching, communication, and cross-functional influence skills.
• Experience with SAP, electronic quality systems, manufacturing systems, and packaging inspection or vision-system applications preferred.