Senior Quality Manager - Drug Products

We are the people who give possibilities purposeBD 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 Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

• Lead plant-wide Quality programs and compliance activities, overseeing CAPAs, non-conformances (QNs), planned deviations, and internal audit readiness across multiple departments
• Drive Quality oversight for change control and engineering initiatives within the Drug Products function, ensuring alignment with regulatory and internal standards
• Serve as a key member of the Quality Leadership Team, ensuring site compliance with procedures, regulatory requirements, and industry standards for medical device and pharmaceutical manufacturing
• Champion continuous improvement initiatives as part of the Quality Steering Committee, driving quality system enhancements and supporting departmental and site-wide goals
• Contribute to operational excellence projects, including blitzes, Six Sigma, and cross-functional improvement initiatives
• Own Annual Product Reviews (APRs), ensuring thorough evaluation of product quality and compliance performance
• Analyze quality data and trends to proactively identify risks and initiate improvement projects that address gaps and deficiencies
• Empower and coach Quality teams, fostering a culture of accountability, continuous improvement, and compliance excellence
• Partner cross-functionally with Quality, Production, and Engineering teams to identify root causes of quality issues and implement effective corrective actions
• Prepare and deliver presentations for management reviews and site forums, ensuring clear communication of Quality performance and key insights
• Lead and develop Quality team members, including engineers, technicians, and calibration staff, through Regular one-on-one engagement, Performance coaching and career development, Workload prioritization and resource planning, Recognition and employee engagement practices
• Act as a subject matter expert (SME) on QMS and drug product regulations, mentoring cross-functional teams on requirements, expectations, and best practices
• Serve as a delegate for the Plant Quality Associate Director, representing Drug Product Quality in cross-functional and site leadership discussions as needed
• Support external audit readiness and execution, including FDA, ISO, corporate, and customer audits
• Ensure full compliance with safety and environmental regulations, including RCRA hazardous waste requirements and all applicable BD policies
• Uphold quality assurance standards and practices, ensuring consistent application of sound Quality principles across all operations

• Bachelor's degree with 8 years relevant experience or a combination of equivalent education and experience
• Previous supervisory or management with 5 years relevant experience managing direct reports
• Previous GMP experience with 5 years in Pharmaceutical, Drug Product, OTC and/or Combination Product experience

• Degree in Engineering or Life Sciences
• Six Sigma Certification

• Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measurable / confirmed results
• Track record of root cause determination and effective corrective / preventive action implementation
• Change management authorship, review, and/or approval
• Validation and qualification authorship, review, approval, and/or execution such as (Install/Operational/Performance Qualification (IQ/OQ/PQ), Test Method Validation (TMV), and Measurement Systems Analysis (MSA))
• Provides training for product development teams and continuous improvement teams on best practices
• Conducts audits as member of a quality system audit team (e.g. SME, etc...)
• Writes and leads risk management activities including risk management reports, risk assessment and risk analyses
• Working knowledge of ISO…