Sr. Director Quality

B. Braun Medical, Inc.

Company: B. BRAUN MEDICAL (US) INC
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: Yes
Requisition : 10067

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

Postition Summary

Responsibilities:
Essential Duties

• Provides enterprise level leadership for the organization's Quality function, setting strategic direction and ensuring sustained compliance, product quality, and patient safety.
• Develops and executes longterm Quality strategies and multiyear roadmaps aligned with corporate, franchise, and operational objectives.
• Establishes, governs, and continuously improves the organizational Quality Management System (QMS), ensuring effectiveness, scalability, and regulatory readiness.
• Anticipates, identifies, and mitigates systemic quality risks, including potential quality failures across materials, manufacturing, processes, systems, and supply chain.
• Defines and oversees robust mechanisms for evaluation of raw materials, components, inprocess goods, finished products, and quality systems, ensuring timely and effective corrective and preventive actions.
• Champions a strong quality culture through leadership behaviors, governance, accountability, and continuous improvement.
• Solicits and integrates internal and external stakeholder feedback, regulatory intelligence, and industry best practices to drive sustained performance improvement.
• Serves as the senior Quality representative during external regulatory inspections, audits, and high impact customer or partner engagements.
• Provides executive oversight of recurring and critical Quality operations, ensuring efficient execution while identifying opportunities for simplification, standardization, and efficiency.
• Allocates and optimizes resources, budgets, and investments in alignment with business priorities and riskbased decision making.
• Leads and develops a senior Quality leadership organization (Directors, Senior Managers, Managers, and professionals), with full accountability for hiring, development, performance management, succession planning, and organizational design.
• Acts as a key contributor to enterprise strategic planning, business reviews, and executive decision making forums.
• Establishes, recommends, and approves Quality policies, practices, and procedures with significant organizational and regulatory impact.
• Functions as the management representative for Quality in accordance with organizational policies and applicable laws and regulations.
• Holds ultimate Quality accountability for assigned sites, functions, and product portfolios.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

General:
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

Limit of Authorization/Authority:

Please refer to the Corporate Guidelines or BBMUS Guidelines or job specific authorities where applicable. This list is however not exhaustive and may be amended by the Management from time to time.

Education and Professional Knowledge:

• Bachelor's degree in a scientific, engineering, or related discipline required
• Master's degree or advanced degree preferred

Experience:

• 15+ years of progressively responsible experience in Quality within a regulated industry (pharmaceutical, biotechnology preferred)
• 8+ years of senior leadership experience managing complex, multi level Quality organizations
• Demonstrated experience with enterprise or multi site Quality oversight and regulatory engagement

Certification:

Applicable industry/professional certification preferred.

Knowledge and Skills Requirements:

- Extensive breadth and depth of organizational, technical, regulatory, and industry knowledge

- Ability to integrate complex information across multiple disciplines and business units

- Strategic thinker with strong execution capability

- Demonstrated executive presence, influencing, and decision making skills

- Proven ability to lead…