Manager III, Quality Control (Chemistry Lab)
New
Job Summary
Join B. Braun as Manager III, Quality Control and lead a Chemistry Laboratory team responsible for ensuring product quality, regulatory compliance, and operational excellence. In this role, you will oversee laboratory operations, drive continuous improvement initiatives, and lead a team of chemists and quality professionals in a GMP-regulated environment to support the delivery of safe, high-quality healthcare products.
Key Responsibilities
- Lead and develop a Quality Control Chemistry Laboratory team, overseeing daily operations, testing activities, and employee performance in a GMP-regulated manufacturing environment.
- Ensure compliance with FDA regulations (21 CFR Parts 210, 211, and 820), Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and other applicable regulatory requirements.
- Oversee laboratory testing, product inspections, investigations, documentation, and quality processes to ensure products consistently meet company, customer, and global regulatory standards.
- Develop, implement, and continuously improve quality control programs, testing methods, and laboratory processes to enhance efficiency, quality, and compliance.
- Drive root cause investigations, corrective and preventive actions (CAPA), and continuous improvement initiatives to support operational excellence.
- Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory Affairs, and Technical Services, to resolve quality issues and support business objectives.
- Monitor key performance metrics, manage departmental priorities and budgets, and ensure achievement of quality, productivity, and compliance goals.
- Provide leadership, coaching, and professional development opportunities to staff while fostering a culture of quality, accountability, and continuous improvement.
Qualifications
- Bachelor’s degree in chemistry, Chemical Engineering, Biochemistry, or a related scientific field required.
- Extensive experience leading Quality Control laboratories within a pharmaceutical, medical device, or regulated manufacturing environment.
- Strong knowledge of LabWare LIMS, GMP regulations, and quality systems.
- Familiarity with testing standards and methods from the United States Pharmacopeia (USP), Health Canada, and the European Medicines Agency (EMA).
- Proven leadership experience managing large teams and driving performance across multiple shifts.
- Master's degree preferred.
- 10+ years of quality control, quality assurance, or related experience.
Additional Information
- Occasional business travel required.
- Valid driver's license and passport preferred.
- Work environment includes office, manufacturing, laboratory, and warehouse settings.
Salary Range: $139,000 - $173,000