Director, Lab Quality Control — Chemistry & Microbiology

B. Braun US Pharmaceutical Manufacturing LLC; Irvine (CA); On-site; USD 184,000 - 261,000; Full time

Job summary

B. Braun Medical Inc. in Irvine, California is seeking a Director of Lab Quality Control to lead the scientific and operational aspects of QC Chemistry and QC Microbiology, ensuring product quality and regulatory compliance.

You will shape the site laboratory strategy, oversee testing activities, and drive critical quality initiatives across the organization while maintaining inspection readiness and alignment with portfolio requirements.

Qualifications

• Bachelor’s degree in a STEM discipline required; master’s degree or doctorate preferred.
• 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.
• Experience with laboratory compliance, data integrity, investigations, analytical methods, and pharmaceutical quality systems.
• Experience supporting regulatory inspections, customer audits, and interactions with senior stakeholders.

Responsibilities

• Develop, maintain, and execute the site Quality Control strategy in alignment with business objectives and regulatory expectations.
• Provide strategic oversight for QC Chemistry and QC Microbiology operations including testing activities.
• Establish and govern laboratory standards for testing compliance, data integrity, investigations, and workflows.
• Serve as the primary site SME during regulatory inspections and customer audits.
• Partner with QA, Manufacturing, Sterility Assurance, Engineering, Validation, 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.

Skills

Leadership

Quality control

Analytical methods

Regulatory inspections

Education

Bachelor’s degree in STEM

Master’s preferred

Job description

B. Braun Medical Inc. in Irvine, California is seeking a Director of Lab Quality Control to lead the scientific and operational aspects of QC Chemistry and QC Microbiology, ensuring product quality and regulatory compliance.

You will shape the site laboratory strategy, oversee testing activities, and drive critical quality initiatives across the organization while maintaining inspection readiness and alignment with portfolio requirements.