Quality Manager (Packaging)

Responsibilities:

• Packaging Operations Quality Oversight
• 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.
• Quality Systems, Compliance, and 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.
• People Leadership and Operational Partnership
• 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:

• Education:
• 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.
• 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.
• Why Join Us?
• To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
• We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
• To learn more about BD visit https://bd.com/careers.
• Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
• .
• Primary Work Location
• USA TX - El Paso - Northwestern Dr.
• Additional Locations
• Work Shift

Experience:

• 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.

Why Join Us?

Primary Work Location

Preferred Qualifications

• Bachelor's degree in Engineering, Science, Pharmacy, Packaging, or a related technical discipline. Master's degree preferred.
• Experience supporting FDA or other health-authority inspections is strongly preferred.
• Experience with SAP, electronic quality systems, manufacturing systems, and packaging inspection or vision-system applications preferred.
• Optional Skills