UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. UBC fosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. We believe in an inclusive workplace that fosters creativity.
Director GCP Compliance
Location
United States
Posted
13 days ago
Salary
Not specified
No structured requirement data.
Job Description
Job Requirements
- Masters or Bachelor's 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
- Advanced knowledge and understanding of clinical development programs and clinical trial processes
- Comprehensive knowledge of GCP/GVP/ICH and worldwide Regulatory Health Authority 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
- 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
- Strong understanding of the end-to-end drug development life cycle
- Experience managing the full vendor/supplier lifecycle
- Proven inspector-facing leadership during regulatory inspections
- 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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