Director, GCP Compliance – CRO Services

Job Description:

• The Director of GCP Compliance develops the strategy for, and directs the overall management of the Clinical QC, Controlled Document/Training, and Continuous Improvement teams within Global Quality Compliance.
• The Director GCP Compliance is responsible for the strategy to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation activities, notification, inspection liaison activities during the inspection, development and approval of the inspection response (Inspection Response Document), and implementation of Corrective Action and Preventive Actions (CAPA) Plan) are managed and executed consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory responsiveness and compliance.
• The Director, GCP Compliance, is responsible for identifying and analyzing changes to GCP regulations globally and assessing complaints to determine GCP compliance status.
• The Director of GCP will report to the Vice President, Global Quality Compliance.
• Ensures the effective execution of the Clinical QC team including the establishment of standards for reviews of TLFs, CSRs, etc. for submission readiness.
• Works with the Continuous Improvement Administrator and related CAPA Analysts to develop effective working practices for the execution and administration of a corporate continuous improvement program.
• Responsible for the development, maintenance and optimization of Quality Management documents including but not limited to Standard Operating Procedures, Working Practices and Corporate Policies.
• Responsible for management oversight for the corporate UBC training program.
• Responsible for managing employee training files and related documentation for the UBC organization including the establishment of role based training matrices.
• Lead a team that supports regulatory inspections related to both UBC's overall GCP/GVP compliance across all service areas as well as supporting the regulatory inspections of clients.
• Establish the vision and implement the strategy for GCP/GVP Compliance within UBC to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP Guidelines, and UBC's quality management system.
• Deploy comprehensive GCP/GVP Inspection Readiness plans, which involves influencing and leading large cross-functional teams.
• Responsible for the development, maintenance, and continuous improvement of risk-based practices and approaches related to building quality within clinical research activities.

Requirements:

• Deep expertise in Computer System Validation (CSV) using both waterfall and agile methodologies.
• Strong working knowledge of clinical research regulations related to computer systems.
• Proven ability to audit CSV processes and electronic systems for compliance.
• Demonstrated experience partnering cross-functionally with IT and software development teams to ensure regulatory compliance and operational efficiency.
• Extensive hands-on experience within GxP environments, with a primary focus on GCP.
• Direct auditing experience across clinical trial sites, laboratories, manufacturing facilities, and technology/service vendors supporting drug development.
• Strong understanding of the end-to-end drug development life cycle.
• Experience managing the full vendor/supplier lifecycle (onboarding, qualification, oversight, requalification, retirement) to ensure regulatory, quality, and compliance standards are met.
• Proven inspector-facing leadership during regulatory inspections (beyond backroom support).
• Demonstrated ownership of inspection strategy, preparation, execution, and response activities.
• Experience interacting directly with global health authorities.

Benefits:

• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*

• Tuition reimbursement

• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance
• Discount programs

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