Senior Quality Leader – Drug Product & GMP Compliance

BD; Sandy (UT); Sur place; USD 140 000 - 180 000; Plein temps

Résumé du poste

BD is seeking a Quality Leader in Sandy, Utah to drive plant-wide quality programs and compliance across Drug Product operations. The role oversees CAPAs, change control, audits, and continuous improvement, while mentoring engineers and technicians.

You will partner with Quality, Production, and Engineering to implement robust quality systems, analyze quality data, and lead management reviews. On-site collaboration is essential to BD’s regulatory readiness and culture.

Qualifications

• Bachelor’s degree with 8 years relevant experience or equivalent education and experience.
• Five years supervisory or management experience managing direct reports.
• Five years GMP experience with Drug Product, Pharmaceutical, OTC and/or Combination Product experience.

Responsabilités

• Lead plant-wide Quality programs and compliance activities across multiple departments.
• Drive Quality oversight for change control and engineering initiatives within Drug Products.
• Serve as a key member of the Quality Leadership Team and ensure site compliance with regulatory standards.
• Champion continuous improvement initiatives and quality system enhancements.
• Contribute to operational excellence projects including Six Sigma and cross-functional improvements.
• Own Annual Product Reviews (APRs) and evaluate product quality and compliance performance.
• Analyze quality data and trends to identify risks and drive improvement projects.
• Coach Quality teams and foster accountability and compliance culture.
• Partner with Quality, Production, and Engineering to implement corrective actions.
• Prepare and deliver management presentations on Quality performance and insights.
• Lead and develop Quality team members through coaching and workload planning.
• Serve as SME on QMS and drug product regulations and train cross-functional teams.
• Represent Drug Product Quality in site leadership discussions when needed.
• Support external audit readiness and execution (FDA, ISO, etc.).
• Ensure compliance with safety and environmental regulations per BD policies.

Connaissances

Quality leadership

Root cause analysis

Change management

Training

Auditing

Cross-functional collaboration

Formation

Bachelor’s degree

Engineering or Life Sciences degree

Six Sigma Certification

Outils

Minitab

SAP

TrackWise

Description du poste

BD is seeking a Quality Leader in Sandy, Utah to drive plant-wide quality programs and compliance across Drug Product operations. The role oversees CAPAs, change control, audits, and continuous improvement, while mentoring engineers and technicians.

You will partner with Quality, Production, and Engineering to implement robust quality systems, analyze quality data, and lead management reviews. On-site collaboration is essential to BD’s regulatory readiness and culture.