B. Braun US Pharmaceutical Manufacturing LLC

Job Posting Location: Irvine, California, United States

Functional Area: Quality

Working Model: Onsite

Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday

Shift: 5X8

Relocation Available: No

Requisition ID: 12096

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

Position Summary

Provide Quality oversight across the Quality System to support compliant manufacturing and product distribution. This role ensures adherence to regulatory requirements, data integrity standards, and internal quality processes, while leading audit readiness efforts, coordinating audit responses with cross-functional teams, and maintaining key regulatory documentation, including the Site Master File and certifications.

Key Responsibilities

• Review and approve SOPs, protocols, reports, and manufacturing data (including metadata)
• Perform timely Quality review of data supporting batch release
• Ensure compliance with FDA, ICH, and internal Quality System requirements
• Support regulatory compliance related to product safety and quality
• Review records to ensure data integrity and industry compliance
• Provide Quality oversight for investigations, including review and approval of reports
• Oversee equipment and software qualification, calibration, and validation activities
• Partner with Corporate Quality to implement standardized processes and ensure compliance
• Support audit readiness activities, including preparation and inspection support
• Follow up with cross-functional teams on audit responses and corrective actions
• Maintain and update the Site Master File and regulatory certifications

Qualifications

• Bachelor's degree required
• A minimum of 4 years of regulatory experience
• Industry certification preferred

Skills & Experience

• Working knowledge of quality systems and regulatory requirements
• Strong attention to detail and organizational skills
• Ability to manage priorities and solve routine issues independently

Additional Information

• Primarily office-based with occasional manufacturing environment exposure
• Ability to perform light physical tasks (up to 20 lbs)
• Regular and predictable attendance required

Salary Range- $90,000-107,000/ annually