QA GCP Auditor
3 weeks ago
Job Summary
Our European activities are growing rapidly, and we are currently seeking a full-time QA GCP Auditor to join our Quality Assurance team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous GCP expertise and can develop and grow within an individual career path, then this is the opportunity for you.
We are interested in office-based individuals in London, Munich, Leuven or Warsaw. Hybrid working may be available depending on country policy and after 6 month onboarding period.
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
- Bachelor’s degree in life sciences or nursing;
- 2 or more years of experience in a QA GCP department in a related industry;
- Experience of GCP site audits and vendor audits is highly preferred
- Excellent written and verbal communication skills
- Exceptional teamwork skills
- Ability to work independently.
Travel: Average of 50% across the UK
Medpace OverviewMedpace 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)
- 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 Best Mid-size Companies in 2021, 2022 and 2023
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
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