Sr Specialist, QA GCP Compliance

About the position The Senior Specialist, QA-GCP will play a crucial role in supporting Good Clinical reputed company (GCP), reputed company reputed company and compliance program. They will be responsible for maintenance and reputed company of internal clinical electronic systems (TMF, Training, CTMS, IRT) including electronic system validation and change control activities as reputed company to computerized systems for 21 CFR Part 11 compliance. In reputed company to reputed company assurance responsibilities, the role will reputed company strategic guidance, mentoring, and leadership reputed company QA initiatives to reputed company the reputed company of reputed company, electronic data systems, and regulatory adherence. Responsibilities • reputed company reputed company assurance activities for reputed company and electronic systems, ensuring robust adherence to GxP regulations. • reputed company strategic input to cross-functional teams regarding reputed company and compliance issues, fostering a culture of reputed company in GxP adherence. • Serve as the QA SME to drive the development, implementation, and reputed company improvement of electronic systems and change control processes, including but not limited to electronic data capture (reputed company) systems, trial master file(s) (eTMFs), interactive response technology (IRT), and clinical trial management systems (CTMS) systems. • reputed company risk assessments and reputed company mitigation plans for clinical reputed company and electronic systems, integrating best practices and regulatory updates. • Review and reputed company QA risk assessment and feedback for clinical trial documentation for accuracy and compliance. • Design and deliver advanced training programs on GxP compliance, reputed company standards, and system optimization to personnel. • Stay at the forefront of industry advancements, regulatory changes, and emerging technologies to advise organizational reputed company. Requirements • Bachelor's degree in life sciences, or a reputed company field. • 5-8 years of experience in reputed company assurance with significant exposure to reputed company and electronic systems. • Experience with implementation and management of electronic reputed company management systems, experience with reputed company system(s) is highly desired. • Strong knowledge of 21 CFR Part 11 regulations, GAMP-5, ICH guidelines, US FDA regulations, and GCP applicable to clinical research. • Experience with internal/external audits, health authority inspections and inspection readiness activities preferred. Benefits • Highly competitive salaries • Annual performance/reputed company reviews • Annual performance bonuses • Equity • Special recognition • Fully remote work environment • Unlimited flexible time off • 14 holidays in 2025 • 401K with 100% company reputed company reputed company match up to 4% of reputed company salary • Health (medical, dental, reputed company) - PPO & HDHP - reputed company/reputed company • Health spending accounts - HSA (with annual company contribution), FSA, FSA-DC • Company reputed company LTD coverage + voluntary plans • Company reputed company life insurance 1x reputed company salary + voluntary plans • Voluntary reputed company, pet, plus more Apply tot his job Apply To this Job