Responsibilities :
- Work as a trusted partner with Medpace operations to promote a culture of continuous improvement;
- Coordinate and conduct internal system audits and external investigative site/vendor audits;
- Create, maintain, and revise departmental Standard Operating Procedures, forms, and templates;
- Coordinate, conduct, and track company-wide Regulatory Training (ICH/GCP, GLP, Medical Device);
- Coordinate, conduct, track, and resolve company-wide Corrective Action/Preventative Action (CAPA) investigations;
- Develop training materials and applicable tests and guides;
- Work with outside clients/sponsors.
- Host Sponsor audits and Regulatory Inspections
- Act as QA Project Leader, managing timelines and coordinating workload amongst QA Auditors
Qualifications :
- Bachelor’s degree in life sciences or nursing;
- 2 or more years of experience in a QA department in a related industry;
- Experience of GCP site audits and vendor audits;
- Excellent written and verbal communication skills;
- Exceptional teamwork skills; and
- Ability to work independently.
Travel: Average of 50% across Poland.
Medpace Overview :
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 its 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
- 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
Awards
- Recognized by Forbes as one of America’s Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
More Information
- Experience Level Junior
- Total Years Experience 0-5
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