Director, Laboratory Quality Control & Compliance

B. Braun Medical Inc.; Irvine (CA); In loco; USD 184.000 - 261.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare

401(k) plan

Tuition reimbursement

Descrizione del lavoro

B. Braun Medical Inc. in Irvine seeks a Director, Lab Quality Control to serve as the senior site authority for QC Chemistry and Microbiology, leading scientific and regulatory initiatives to protect product quality and ensure inspection readiness.

You will set the site QC strategy, oversee chemistry and microbiology operations, ensure data integrity and robust investigations, and collaborate across QA, Manufacturing, Engineering, and Regulatory Affairs to enable timely product release.

Competenze

• Bachelor’s degree in STEM required; master’s or PhD preferred.
• 10+ years in lab quality control or pharmaceutical manufacturing with leadership.
• Expertise in QC Chemistry and/or QC Microbiology in sterile drug products.
• Experience with compliance, data integrity, investigations, analytical methods, and QS.
• Proven record supporting regulatory inspections and audits with stakeholders.
• Ability to resolve complex scientific, operational, and compliance issues.
• Lean Six Sigma certification or demonstrated Lean/CI experience.

Mansioni

• Develop and execute the site QC strategy aligned with business objectives.
• Provide strategic oversight for QC Chemistry and QC Microbiology operations.
• Establish and govern standards for testing, data integrity, investigations, and methods.
• Serve as SME during regulatory inspections and customer audits.
• Collaborate with QA, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Lead laboratory optimization, automation, and Lean deployment.
• Foster a culture of quality, accountability, and continuous improvement.

Conoscenze

Leadership

QC Chemistry

QC Microbiology

Regulatory inspections

Data integrity

Lean Six Sigma

Formazione

Bachelor’s degree in STEM

Master’s or PhD preferred

Descrizione del lavoro

B. Braun Medical Inc. in Irvine seeks a Director, Lab Quality Control to serve as the senior site authority for QC Chemistry and Microbiology, leading scientific and regulatory initiatives to protect product quality and ensure inspection readiness.

You will set the site QC strategy, oversee chemistry and microbiology operations, ensure data integrity and robust investigations, and collaborate across QA, Manufacturing, Engineering, and Regulatory Affairs to enable timely product release.