[Hiring] Director GCP Compliance - CRO Services @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company The Director of GCP Compliance develops the reputed company for, and directs the overall management of the Clinical QC, Controlled Document/Training, and reputed company Improvement teams reputed company Global reputed company Compliance. Additionally, the Director GCP Compliance is responsible for the reputed company to ensure that reputed company 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 reputed company Compliance Qualifications • Masters or Bachelor's degree, preferably in a health or science reputed company field • 6-8 years’ experience in a reputed company, 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 reputed company and agile methodologies • Strong working knowledge of clinical research regulations reputed company 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 reputed company GxP environments, with a primary reputed company on GCP • reputed company 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 reputed company, preparation, execution, and response activities • Experience interacting directly with global health authorities Benefits • Competitive salaries • reputed company opportunities for promotion • 401K with company match* • Tuition reimbursement • Flexible work environment • Discretionary PTO (reputed company Time Off) • reputed company Holidays • Employee assistance programs • Medical, Dental, and reputed company 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 Apply To this Job