Overview

B. Braun Medical, Inc.Company: B. Braun US Pharmaceutical Manufacturing LLCJob Posting Location: Irvine, California, United StatesFunctional Area: QualityWorking Model: OnsiteDays of Work: Friday, Thursday, Wednesday, Tuesday, MondayShift: 5X8Relocation Available: NoRequisition ID: 14755B. 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 Ready to lead where science, quality, and patient safety come together? Join B. Braun and shape the future of laboratory excellence while driving the strategy, compliance, and innovation behind critical healthcare products. Why this role matters: The Director, Lab Quality Control serves as the senior site authority for Quality Control Chemistry and Microbiology, providing the scientific and operational leadership needed to protect product quality and maintain regulatory compliance. This role establishes the site's laboratory strategy, leads critical quality initiatives, and ensures that laboratory operations remain scientifically sound, inspection-ready, and aligned with business and product portfolio requirements. How you will make an impact: Develop, maintain, and execute the site Quality Control strategy in alignment with business objectives, product portfolio requirements, and regulatory expectations. Provide strategic oversight for QC Chemistry and QC Microbiology operations, including release, stability, raw material, in-process, microbiological, and sterility-related testing activities. Establish and govern laboratory standards for testing compliance, data integrity, investigations, sample management, analytical methods, specifications, and laboratory workflows. Serve as the primary site subject matter expert during regulatory inspections and customer audits involving laboratory operations and quality systems. Partner with Quality Assurance, Manufacturing, Sterility Assurance, Engineering, Validation, Technical Services, Supply Chain, and Regulatory Affairs to support site operations and timely product release. Lead laboratory optimization, method modernization, automation, Lean deployment, and quality system improvement initiatives. Foster a culture of quality, accountability, scientific rigor, collaboration, safety, and continuous improvement. What sets you up for success: Bachelor's degree in a STEM discipline required; master's degree or doctorate preferred. 10+ years of related experience, including significant leadership responsibility within laboratory quality control or pharmaceutical manufacturing. Demonstrated expertise in QC Chemistry and/or QC Microbiology operations within a sterile drug product manufacturing environment. Significant experience with laboratory compliance, data integrity, out-of-specification and out-of-trend investigations, analytical methods, and pharmaceutical quality systems. Proven experience supporting regulatory inspections, customer audits, and interactions with senior internal and external stakeholders. Ability to resolve complex scientific, operational, and compliance issues using sound judgment, technical expertise, and risk-based decision-making. Lean Six Sigma certification or de