Sr Specialist, QA GCP Compliance
About the position
The Senior Specialist, QA-GCP will play a crucial role in supporting Good Clinical Practice (GCP), quality oversight and compliance program. They will be responsible for maintenance and oversight of internal clinical electronic systems (TMF, Training, CTMS, IRT) including electronic system validation and change control activities as related to computerized systems for 21 CFR Part 11 compliance. In addition to quality assurance responsibilities, the role will provide strategic guidance, mentoring, and leadership within QA initiatives to uphold the integrity of clinical trials, electronic data systems, and regulatory adherence.
Responsibilities
• Lead quality assurance activities for clinical trials and electronic systems, ensuring robust adherence to GxP regulations.
• Provide strategic input to cross-functional teams regarding quality and compliance issues, fostering a culture of excellence in GxP adherence.
• Serve as the QA SME to drive the development, implementation, and continuous improvement of electronic systems and change control processes, including but not limited to electronic data capture (EDC) systems, trial master file(s) (eTMFs), interactive response technology (IRT), and clinical trial management systems (CTMS) systems.
• Perform risk assessments and develop mitigation plans for clinical quality and electronic systems, integrating best practices and regulatory updates.
• Review and provide QA risk assessment and feedback for clinical trial documentation for accuracy and compliance.
• Design and deliver advanced training programs on GxP compliance, quality standards, and system optimization to personnel.
• Stay at the forefront of industry advancements, regulatory changes, and emerging technologies to advise organizational strategy.
Requirements
• Bachelor's degree in life sciences, or a related field.
• 5-8 years of experience in quality assurance with significant exposure to clinical trials and electronic systems.
• Experience with implementation and management of electronic quality management systems, experience with Veeva 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/merit reviews
• Annual performance bonuses
• Equity
• Special recognition
• Fully remote work environment
• Unlimited flexible time off
• 14 holidays in 2025
• 401K with 100% company Safe Harbor match up to 4% of base salary
• Health (medical, dental, vision) - PPO & HDHP - Cigna/Principal
• Health spending accounts - HSA (with annual company contribution), FSA, FSA-DC
• Company paid LTD coverage + voluntary plans
• Company paid life insurance 1x base salary + voluntary plans
• Voluntary legal, pet, plus more
Apply Now
Apply Now
The Senior Specialist, QA-GCP will play a crucial role in supporting Good Clinical Practice (GCP), quality oversight and compliance program. They will be responsible for maintenance and oversight of internal clinical electronic systems (TMF, Training, CTMS, IRT) including electronic system validation and change control activities as related to computerized systems for 21 CFR Part 11 compliance. In addition to quality assurance responsibilities, the role will provide strategic guidance, mentoring, and leadership within QA initiatives to uphold the integrity of clinical trials, electronic data systems, and regulatory adherence.
Responsibilities
• Lead quality assurance activities for clinical trials and electronic systems, ensuring robust adherence to GxP regulations.
• Provide strategic input to cross-functional teams regarding quality and compliance issues, fostering a culture of excellence in GxP adherence.
• Serve as the QA SME to drive the development, implementation, and continuous improvement of electronic systems and change control processes, including but not limited to electronic data capture (EDC) systems, trial master file(s) (eTMFs), interactive response technology (IRT), and clinical trial management systems (CTMS) systems.
• Perform risk assessments and develop mitigation plans for clinical quality and electronic systems, integrating best practices and regulatory updates.
• Review and provide QA risk assessment and feedback for clinical trial documentation for accuracy and compliance.
• Design and deliver advanced training programs on GxP compliance, quality standards, and system optimization to personnel.
• Stay at the forefront of industry advancements, regulatory changes, and emerging technologies to advise organizational strategy.
Requirements
• Bachelor's degree in life sciences, or a related field.
• 5-8 years of experience in quality assurance with significant exposure to clinical trials and electronic systems.
• Experience with implementation and management of electronic quality management systems, experience with Veeva 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/merit reviews
• Annual performance bonuses
• Equity
• Special recognition
• Fully remote work environment
• Unlimited flexible time off
• 14 holidays in 2025
• 401K with 100% company Safe Harbor match up to 4% of base salary
• Health (medical, dental, vision) - PPO & HDHP - Cigna/Principal
• Health spending accounts - HSA (with annual company contribution), FSA, FSA-DC
• Company paid LTD coverage + voluntary plans
• Company paid life insurance 1x base salary + voluntary plans
• Voluntary legal, pet, plus more
Apply Now
Apply Now