Senior Quality Manager – Drug Products

Regulatory Jobs; Sandy (UT); On-site; USD 140,000 - 210,000; Full time

Job summary

Becton, Dickinson and Company (BD) seeks a senior Quality leader to oversee plant-wide quality programs, CAPA, audits, and regulatory compliance across Drug Product operations in Utah. The role partners with Quality, Production and Engineering to identify root causes, implement corrective actions, and drive continuous improvement.

You will coach and develop Quality teams, lead APRs, ensure safety and regulatory compliance, and represent the site in management discussions, while aligning with ISO

Qualifications

• Bachelor’s degree with 8 years relevant experience or a combination of equivalent education and experience.
• 5 years supervisory experience managing direct reports.
• 5 years GMP experience in Pharmaceutical, Drug Product, OTC and/or Combination Product (drug-led).

Responsibilities

• Lead plant-wide quality programs and compliance across departments.
• Oversee CAPAs, non-conformances, deviations, and audit readiness.
• Drive quality oversight for change control and engineering initiatives.
• Serve on the Quality Leadership Team and ensure site regulatory compliance.
• Champion continuous improvement initiatives and QMS enhancements.
• Own Annual Product Reviews (APRs).
• Analyze quality data to identify risks and drive improvements.
• Coach and empower Quality teams.
• Partner with Quality, Production and Engineering to implement corrective actions.
• Prepare and deliver management presentations.

Skills

Quality leadership

CAPA management

Regulatory compliance

Change control

Root cause analysis

Auditing

Training and coaching

Project management

Six Sigma

QMS knowledge

Education

Bachelor's degree

Pharma/Drug product experience

Six Sigma Certification

Tools

Minitab

SAP

TrackWise

Job description

We are the people who give possibilities purpose

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.

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

Work Shift

NA (United States of America)