Sr. GCP Quality Assurance Specialist
2 weeks ago
Responsibilities for the Sr. QA Specialist include:
• Overseeing and managing QA compliance for GxP activities, primarily GCP
• Communicating and collaborating with regulatory authorities & clients during regulatory inspections and sponsor audits
• Creating and implementing process improvements and nourishing key relationships with stakeholders
• Leading meetings, trainings, presentations, and timeline communications
Qualifications for the Sr. QA Specialist include:
• 10+ years of experience in the pharmaceutical industry and 3 - 5 years of clincial quality experience
• In-depth GCP experience in auditing internally and externally across all clinical research phases
• Ability to travel to research sites when necessary
Compensation for the Sr. QA Specialist includes:
• Salary Range: $80 - 87/hr. based on professional experience
• Competitive comprehensive benefits package included
Keywords:
QA compliance manager, quality assurance, QA, management, GxP, GCP, GLP, GMP, auditing, clinical research, regulatory, inspections, sponsor audits, stakeholder management, process improvement, travel, investigator site audits, TMF audits, QMS, communication, remote, united states, US
#LI-PB2 #LI-REMOTE
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