Senior Director Lab Quality Control & Regulatory Excellence

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

Benefits offered by this job

Healthcare

401(k)

Tuition reimbursement

Job summary

B. Braun is seeking a Director of Quality Control Labs to lead the site’s QC Chemistry and QC Microbiology operations at Irvine, ensuring product quality and regulatory readiness.

You will shape the laboratory strategy, drive critical initiatives, and oversee testing activities across the site. The role requires strong leadership, deep expertise in pharmaceutical QC, and proven ability to collaborate across Quality, Manufacturing, and Regulatory Affairs to enable compliant, efficient product

Qualifications

• Bachelor’s degree in a STEM discipline is required.
• Significant leadership experience in lab quality control or pharmaceutical manufacturing.
• Expertise in QC Chemistry and/or QC Microbiology in sterile drug product environments.

Responsibilities

• Develop and execute the site QC strategy aligned with business and regulatory expectations.
• Provide strategic oversight for QC Chemistry and QC Microbiology operations, including release, stability, raw materials, and in-process testing.
• Establish laboratory standards for testing compliance, data integrity, investigations, and workflows.
• Serve as the primary site SME during regulatory inspections and customer audits of laboratory operations.
• Collaborate with QA, Manufacturing, Validation, and Regulatory Affairs to support timely product release.

Skills

QC Chemistry

QC Microbiology

Lean Six Sigma

Leadership

Regulatory inspections

Education

Bachelor’s degree in STEM

Master’s or PhD preferred

Job description

B. Braun is seeking a Director of Quality Control Labs to lead the site’s QC Chemistry and QC Microbiology operations at Irvine, ensuring product quality and regulatory readiness.

You will shape the laboratory strategy, drive critical initiatives, and oversee testing activities across the site. The role requires strong leadership, deep expertise in pharmaceutical QC, and proven ability to collaborate across Quality, Manufacturing, and Regulatory Affairs to enable compliant, efficient product