Senior Quality Manager – Drug Products

Job Description

Responsibilities:

• 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

Required Qualifications:

• 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

Preferred qualifications:

• Degree in Engineering or Life Sciences

• Six Sigma Certification

Knowledge and

Skills:

• 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 13485, FDA 21 CFR 211 and 820, and GMP requirements.

• Root cause analysis methodologies (8D, A3, Fishbone, 5 Whys).

• Skilled in Minitab, SAP, and Track Wise (or other ERP/QMS software).

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week…