Director, GCP Compliance – CRO Services
UBC
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
Tech Stack
About the role
- Develops the strategy for, and directs the overall management of the Clinical QC, Controlled Document/Training, and Continuous Improvement teams within Global Quality Compliance.
- Responsible for the strategy to ensure that all phases of Regulatory Health Authority inspections are managed and executed consistently, professionally and proactively.
- Identifying and analyzing changes to GCP regulations globally and assessing complaints to determine GCP compliance status.
- Reporting to the Vice President, Global Quality Compliance.
- 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.
- Ensures the effective execution of the Clinical QC team including the establishment of standards for reviews of TLFs, CSRs, etc. for submission readiness.
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Computer System ValidationGCP regulationsauditingregulatory complianceGxP environmentsdrug development life cyclevendor/supplier lifecycle managementinspection strategyCAPAcontinuous improvement
Soft Skills
leadershipcross-functional collaborationcommunicationstrategic planningproblem-solvinganalytical thinkingteam managementproactive executionorganizational skillstraining development