The Quality Assurance (QA) team needs experienced industry professionals to join it due to rapid expansion. With the goal of upholding organizational and regulatory standards across the whole company, this position will support and audit international trials in a number of therapeutic areas. This is a crucial position within the Quality Assurance division, whose performance depends on the well-honed abilities and qualifications of the QA Auditors.
- Support national and international regulatory standards and guidelines for medications, biologics, and medical devices as the quality program lead for clinical trials.
- Together with clients, create audit management plans and audit strategies for ongoing clinical trials.
- Organize and carry out external investigative site/vendor audits as well as internal system audits in conformity with Good Clinical Practice (GCP) standards.
- 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).
- Bachelor's degree in life sciences
- Minimum of 2 years in QA
- Good Clinical Practice (GCP) experience is necessary
- Proven record of conducting vendor and investigation site audits
- Prior experience hosting regulatory agencies like the FDA
- Ability to travel