Director, REMS Audits & Quality Compliance

United Biosource Corporation • All Virtual Locations, Home Based Position, USA, Remote, US,

13h

About The Position

The Director, REMS Audits & Quality Compliance provides strategic, operational, and enterprise-level leadership for UBC’s REMS audit programs. This role is accountable for the design, scalability, and global oversight of audit strategy, execution, and continuous improvement across all REMS programs. This position ensures that all audit activities—including planning, execution, reporting, and remediation—are conducted in alignment with FDA REMS requirements, global regulatory standards, and UBC quality systems. The Director plays a critical leadership role in inspection readiness, CAPA governance, compliance risk mitigation, and client assurance.

Requirements

• Masters or Bachelors degree, preferably in a health or science related field
• 6-8 years’ experience in a Quality, audit, or inspection hosting field, preferably in a regulated industry
• Experience managing Quality Management programs including but not limited to controlled document management and continuous improvement.
• Advanced knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools is required.
• Comprehensive knowledge of GCP/GVP/ICH and worldwide Regulatory Health Authority requirements.
• Experience with delivering effective CAPA management solutions
• Experience conducting sponsor/site audits
• Excellent organizational, interpersonal, verbal, and written communication skills
• Ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully achieve explicit delivery dates and milestones

Responsibilities

• Ensures the effective execution of the REMS Audit function, including establishment of standards for audit planning, audit questionnaire review, observation grading, and audit reporting to support program and regulatory readiness.
• Partners with REMS leadership and QA to define and operationalize enterprise audit remediation practices, ensuring consistent root cause analysis, CAPA quality, and effectiveness tracking across REMS programs.
• Oversees the development, maintenance, and continuous optimization of Quality Management System (QMS) documentation, including REMS audit SOPs, audit methodologies, work instructions, and governance frameworks.
• Provides oversight of REMS audit training programs, including management of auditor qualifications, role-based training matrices, and maintenance of audit team competency and certification standards.
• Leads audit and compliance support for regulatory inspections, ensuring readiness across all REMS Audit programs and supporting both UBC-led and client-facing regulatory engagements.
• Establishes and executes the vision and strategy for REMS audit compliance, ensuring alignment with FDA REMS requirements, regulatory expectations, and UBC quality standards.
• Drives development and implementation of risk-based audit methodologies, ensuring audit scope, frequency, and depth are aligned with stakeholder risk profiles and regulatory expectations.
• Oversees mandatory audit and compliance training across REMS programs, ensuring all internal and external stakeholders are trained on audit expectations, compliance requirements, and remediation standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Director