Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role 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 are managed and executed consistently, professionally and proactively. • Identifying and analyzing changes to GCP regulations globally • Assessing complaints to determine GCP compliance status • Reporting to the Vice President, Global Quality Compliance Qualifications • 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 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 Apply tot his job
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