USAIrvine Director Quality Control Labs CA 92614

Job description

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 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 demonstrated experience applying Lean and continuous-improvement methodologies preferred. What you will enjoy along the way: The opportunity to shape the laboratory quality strategy for a regulated sterile pharmaceutical manufacturing site. A highly visible leadership role with influence across Quality, Manufacturing, Technical Operations, Supply Chain, and Regulatory Affairs. The ability to modernize analytical capabilities through automation, method lifecycle management, Lean principles, and emerging technologies. Responsibility for developing laboratory leaders, building organizational capability, and determining the effective allocation of people and resources. Meaningful work that directly supports product quality, regulatory compliance, operational reliability, and patient safety. A collaborative environment built on scientific rigor, accountability, diverse perspectives, and continuous improvement. Salary Range: $184,000 - $261,000 At B. Braun, together means better. We believe that diversity makes us stronger. That is why we are committed to creating an inclusive workplace where everyone feels respected, valued, and empowered to make a meaningful impact. We welcome applications from people of all identities, backgrounds, and perspectives. Join us. Apply now! Check us out on Social Media! B. Braun Group LinkedIn Join us and let’s drive advancements in health care! Apply now! 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 . Join us and let’s drive advancements in health care! Apply now! Apply now Imprint Terms of Use Privacy Policy Cookie Settings Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. Copyright © B. 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