Manager III, Quality Assurance (Product Release)

B. Braun Group; 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

Manager III, Quality Assurance (Product Release) Job Description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Manager III, Quality Assurance (Product Release) Company: B. Braun US Pharmaceutical Manufacturing LLC Job Posting Location: Irvine, California, United States Functional Area: Quality Working Model: Onsite Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 13005

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

Job Summary

B. Braun is seeking an experienced Manager III, Quality Assurance (Product Release) to lead a team of 10-15 quality professionals responsible for batch disposition and product release activities in a regulated pharmaceutical manufacturing environment. This critical leadership role ensures products are released safely, efficiently, and in compliance with applicable regulations and company requirements.

Key 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.

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.

Salary Range: $139,000 - $173,000

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com .

Through its 'Sharing Expertise' initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .

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