Senior Quality Manager – Drug Products

Becton Dickinson; Sandy (UT); On-site; USD 150,000 - 210,000; Full time

Job summary

Becton Dickinson in Sandy, Utah, seeks a senior Quality leader to drive plant-wide quality programs, CAPAs, audits, and compliance across Drug Product manufacturing. The role oversees change control and engineering initiatives, ensures alignment with regulatory standards, and champions continuous improvement across the site.

The position partners with Quality, Production and Engineering to identify root causes, implement corrective actions, and mentor engineers, technicians and QA staff.

Qualifications

• Bachelor’s degree with 8+ years relevant experience or equivalent
• Minimum 5 years supervising direct reports in quality
• 5+ years GMP in pharmaceutical/drug product context

Responsibilities

• Lead plant-wide Quality programs and compliance activities across multiple departments
• Drive quality oversight for change control and engineering initiatives
• Serve as a key member of the Quality Leadership Team
• Champion continuous improvement initiatives across the site
• Own Annual Product Reviews (APRs) and analyze quality trends
• Coach and develop Quality teams including engineers and technicians
• Lead audits and regulatory readiness (FDA, ISO, etc.)
• Ensure safety, environment, and BD policies are followed

Skills

Annual Product Reviews

Business Audits

Compliance Programs

Continuous Improvement

Six Sigma

Root cause analysis

QMS

Auditing

Minitab

SAP

TrackWise

Regulatory knowledge

Education

Bachelor’s degree with 8+ years of relevant experience

Six Sigma Certification

Engineering or Life Sciences background

Tools

Minitab

SAP

TrackWise

Job description

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-of a drug led combination product (primary mode of action is drug) 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 TrackWise (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 to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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.

Required Skills

• Annual Product Reviews
• Business Audits
• Compliance Programs
• Continuous Improvement
• Continuous Improvement Activities
• Customer Audits
• Ensure Compliance
• External Audit
• Internal Auditing
• Non-Conformance Reporting (NCR)
• Pharmaceutical Products
• Quality Management
• Quality Management Systems (QMS)
• Safety Standards

Optional Skills

• Six Sigma Project Management .

Primary Work Location USA UT - Sandy Additional Locations Work Shift NA (United States of America)

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

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.