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Job Title: YRC98J – Director GCP Compliance
Brief 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. Additionally, 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.
The Requirements for this Role:
• 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.
Specific job duties:
• Computer System Validation (CSV) expertise: Deep expertise in both waterfall and agile CSV 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 both regulatory compliance and operational efficiency.
• GXP auditing experience: extensive hands-on experience within GxP environments, with a primary focus on GCP, direct auditing experience across clinical trial sites/ laboratories/manufacturing facilities/technology and service vendors supporting drug development, and a strong understanding of the end-to-end drug development life cycle.
• Vendor/Supplier life cycle management: experience managing the full vendor lifecycle, including onboarding, qualification, oversight, requalification, and retirement, with the ability to ensure vendors meet regulatory, quality, and compliance standards.
• Regulatory inspection leadership: proven experience meeting regulatory inspections in an inspector-facing capacity (not limited to backroom support), demonstrated ownership of inspection strategy, preparation, execution, and response activities, experience interacting directly with global health authorities.
• 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 Corpor