Irvine, California, United States On-site Employment USD 210,871 - 301,243 Yearly

B. Braun Avitum is hiring a Sr. Director Quality

About the Role

B. Braun Avitum is looking for a Sr. Director Quality to provide enterprise-level leadership, setting the strategic direction for our Quality function. Guided by our Sharing Expertise® philosophy, you will be responsible for ensuring sustained compliance, product quality, and patient safety while developing long-term strategies aligned with our corporate objectives.

What You'll Do

  • Establish, govern, and continuously improve the organizational Quality Management System (QMS) for effectiveness and regulatory readiness.
  • Anticipate, identify, and mitigate systemic quality risks across materials, manufacturing, processes, systems, and supply chain.
  • Define and oversee robust mechanisms for evaluating raw materials, components, in-process goods, finished products, and quality systems.
  • Champion a strong quality culture through leadership behaviors, governance, accountability, and continuous improvement.
  • Solicit and integrate stakeholder feedback, regulatory intelligence, and industry best practices to drive performance improvement.
  • Serve as the senior Quality representative during external regulatory inspections, audits, and high-impact customer engagements.
  • Provide executive oversight of recurring and critical Quality operations, identifying opportunities for efficiency and standardization.
  • Allocate and optimize resources, budgets, and investments using risk-based decision making.
  • Lead and develop a senior Quality leadership organization, with full accountability for hiring, development, and succession planning.
  • Act as a key contributor to enterprise strategic planning, business reviews, and executive decision-making forums.
  • Establish, recommend, and approve Quality policies, practices, and procedures with significant organizational and regulatory impact.
  • Function as the management representative for Quality in accordance with policies and regulations.
  • Hold ultimate Quality accountability for assigned sites, functions, and product portfolios.

What We're Looking For

  • Bachelor’s degree in a scientific, engineering, or related discipline.
  • 15+ years of progressively responsible experience in Quality within a regulated industry (pharmaceutical or 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.

Nice to Have

  • Master’s degree or advanced degree.
  • Applicable industry or professional certification.

Team & Environment

Provides strategic leadership and direction across multiple departments, sites, or major Quality functions through Directors and senior leaders.

Benefits & Compensation

  • Salary range: $210,871 - $301,243
  • Healthcare coverage
  • 401(k) plan
  • Tuition reimbursement

Work Mode

This position requires onsite work.

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.

Required Skills
Quality ManagementRegulatory ComplianceLeadershipPharmaceuticalsBiotechnologyMulti-site OperationsFDA RegulationsTeam ManagementStrategic PlanningAuditing
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About company
B. Braun Avitum

B. Braun setzt sich seit über 175 Jahren für die Verbesserung der Gesundheitsversorgung ein. Das Unternehmen ist spezialisiert auf Medizintechnik mit einem starken Fokus auf innovative Hard- und Softwarelösungen für medizinische Geräte wie Dialysegeräte und Infusionspumpen.

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Job Details
Department Quality Assurance
Category management
Posted 14 days ago