Quality Control Lab Manager Jobs in Irvine, CA (NOW HIRING)

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.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

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

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Compensation details: 139000-173000 Yearly Salary

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