Senior GCP Quality Assurance Auditor
4 weeks ago
Job Summary
We are seeking an experienced GCP Quality Assurance Specialist to support and audit global trials in various therapeutic areas, maintaining organizational and regulatory standards throughout our company.
This is a vital role in our Quality Assurance department, whose success relies upon the finely tuned skills and background of our QA Auditors.
Responsibilities
- Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for pharmaceuticals, biologics, and medical devices.
- Develop audit management plans and audit strategy with clients for ongoing clinical trials.
- Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines.
- Participate in the development of departmental standard operating procedures, work instructions, forms, and templates.
- Assess validated state and security of proprietary and cloud-based software.
- Develop training materials and applicable interactive tests and proficiency training, including company-wide regulatory training (ICH/GCP).
Qualifications
- Bachelor's degree in life sciences or a related field.
- 5+ years of experience in a QA department in a related industry.
- Experience conducting audits of vendors and investigative sites.
- Experience hosting regulatory authorities and interacting with sponsor/client representatives.
- Independent thinking and planning ability.
- Knowledge and application of Good Clinical Practice (GCP) is required.
- Medical Device and/or Phase 1 experience is a plus.
- Ability to travel up to 30%-40% of time.
- Excellent written and verbal communication skills.
- Exceptional teamwork skills.
- Ability to work independently.
About Medpace
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries.
Our mission is to accelerate the global development of safe and effective medical therapeutics through our scientific and disciplined approach.
We leverage local regulatory and therapeutic expertise across all major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective.
Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas.
The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- Hybrid work-from-home options (dependent upon position and level).
- Competitive PTO packages - starting at 20+ days.
- Company-sponsored employee appreciation events.
- Employee health and wellness initiatives.
- Flexible work schedule.
- Competitive compensation and benefits package.
- Structured career paths with opportunities for professional growth.
- Discounts for local businesses.
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