Manager III, Quality Control (Chemistry Lab)
$139k - $173kB. Braun Melsungen
Manager III, Quality Control (Chemistry Lab)
Company: B. Braun US Pharmaceutical Manufacturing LLC
Job Posting Location: Irvine, California, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 12959
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
- 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.
- 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.
- Occasional business travel required.
- Valid driver's license and passport preferred.
- Work environment includes office, manufacturing, laboratory, and warehouse settings.
$86.4k - $108k
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