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: Wednesday, Tuesday, Thursday, Friday, Monday Shift: 5X8 Relocation Available: Yes Requisition ID: 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 www.bbraunusa.com Postition Summary This role provides executive leadership for B. Braun's Quality function, ensuring robust FDA compliance, driving QMS effectiveness, and leading B. Braun through inspections, audits, and complex FDA remediation activities. It requires deep expertise in sterile manufacturing while guiding enterpriselevel decisions that strengthen product quality, patient safety, and longterm regulatory readiness. Responsibilities: Essential Duties Provides enterpriselevel 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 highimpact 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 decisionmaking 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 through ambiguity, risk, and organizational change Champions advanced Quality strategies, governance models, and continuous improvement methodologies Supervision Given and Received: Provides strategic leadership and direction across multiple departments, sites, or major Quality functions through Directors and senior leaders. Fully accountable for cost, capability, performance, and talent outcomes of the Quality organization. Problem Solving: Exercises independent judgment in resolving highly complex, systemic, and enterprise level problems with significant regulatory, financial, and reputational impact. Contacts/Cooperation: Regularly consults and advises senior leadership and Group / Board level stakeholders on Quality strategy, risk, compliance posture, and organizational capability. Acts as organizational spokesperson on Quality matters related to policy, strategy, and enterprise capability. Additional Requirement: Occasional business travel required, Valid driver's license and passport, Secrecy and invention agreement and non- compete agreement Pay Range- $210,000 - $300,000 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. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Compensation details: 210000-300000 Yearly Salary PIe984b97d7280-37395-39708997
