Associate Director, Clinical Operations Quality Assurance
Eli Lilly and Company
Google Cloud Platform
Quality Assurance Specialist, GCP
CG Oncology
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $94,000 - $110,000 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Conduct internal audits and vendor audits to ensure GCP compliance across clinical trials and related activities
- Review clinical documentation (protocols, investigator brochures, informed consent forms) for regulatory alignment
- Support inspection readiness activities and provide compliance guidance to project teams
- Collaborate with Clinical Operations and Regulatory Affairs to ensure quality standards throughout the trial lifecycle
- Monitor CAPAs related to clinical quality issues and ensure timely resolution
- Assist in development, implementation, and maintenance of QMS policies, procedures, and work instructions
- Perform gap analyses and contribute to QMS improvement initiatives
- Track and report quality metrics to leadership for continuous improvement
- Facilitate training sessions on QMS and GCP-related topics for cross-functional teams
- Manage change control activities related to computerized systems for 21 CFR Part 11 compliance
Requirements
- Bachelor’s degree in life sciences or a related field
- Three (3) years of experience in quality assurance with significant exposure to clinical trials and electronic systems
- Experience with the implementation and management of electronic quality management systems
- Experience with Veeva system(s) is highly desired
- Experience with internal/external audits, health authority inspections, and inspection readiness activities preferred
- Advanced knowledge of GxP Compliance and Quality Assurance processes
- Expertise in risk-based approaches to quality management for clinical and electronic systems
- Exceptional communication, strategic thinking, and leadership skills
- Excellent problem-solving skills and attention to detail with ability to develop and present actionable insights for process improvements and efficiencies
Benefits
- VERY COMPETITIVE SALARIES
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
- FULLY REMOTE WORK ENVIRONMENT
- REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
- HOLIDAYS –In 2025 we will observe 14 holidays
- RETIREMENT – 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
- ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
- LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
- ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More
- Well-Being Benefits eligibility begins on the 1st of the month after hire.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCP complianceinternal auditsvendor auditsQMS policiesgap analysesquality metricsrisk-based approacheselectronic quality management systemsclinical documentation reviewCAPA monitoring
Soft skills
communicationstrategic thinkingleadershipproblem-solvingattention to detailcollaborationtraining facilitationcompliance guidancecontinuous improvementactionable insights
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