Senior QA Product Release Manager – Pharma

B. Braun; Irvine (CA); On-site; USD 139,000 - 173,000; Full time

Job summary

B. Braun US Pharmaceutical Manufacturing LLC in Irvine, CA seeks an experienced Manager III, Quality Assurance (Product Release) to lead a 10–15 member QA team responsible for batch disposition and product release in a regulated pharma setting.

The role ensures releases are safe, efficient, and compliant with FDA regulations and company standards, driving continuous improvement and collaboration across functions.

Qualifications

• Bachelor's degree in a scientific discipline required; Master's degree or higher preferred.
• 10+ years of Quality Assurance experience within a pharmaceutical or biotech manufacturing environment.
• Extensive experience with batch record review and product release.
• Strong knowledge of FDA regulations (21 CFR 210, 211, and Part 11), GMPs, and pharmaceutical manufacturing processes.
• Experience supporting FDA audits and regulatory inspections.
• Proven leadership experience managing large teams and fostering accountability, collaboration, and continuous improvement.

Responsibilities

• Lead and develop a high-performing QA Product Release team responsible for batch review and release activities.
• Plan, prioritize, and assign batch release work while partnering closely with Manufacturing, Planning, QC Laboratories, and other cross-functional teams.
• Ensure compliance with FDA regulations, including 21 CFR Parts 210, 211, and Part 11, GMP requirements, and company quality standards.
• Support regulatory authorities inspections and audits, ensuring inspection readiness and successful outcomes.
• Leverage systems such as SAP, LabWare/LIMS, and TrackWise to support quality and release processes.
• Drive operational excellence through coaching, conflict resolution, employee development, and strong cross-functional collaboration.

Skills

QA leadership

FDA regulatory knowledge

Batch release knowledge

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in a scientific discipline

Master's degree or higher

Tools

SAP

LabWare/LIMS

TrackWise

Job description

B. Braun US Pharmaceutical Manufacturing LLC in Irvine, CA seeks an experienced Manager III, Quality Assurance (Product Release) to lead a 10–15 member QA team responsible for batch disposition and product release in a regulated pharma setting.

The role ensures releases are safe, efficient, and compliant with FDA regulations and company standards, driving continuous improvement and collaboration across functions.