This role is a project-based consulting opportunity.**Responsibilities**:- Assist in vendor qualification of CROs, including preparing evaluation, quality agreements- Vendor oversight and monitoring, as needed- Experience with performing investigations of errors investigations and risk assessments- Create controlled documents for compliance to regulatory requirements of the study planning, performance, final reporting- Computer Software Validations/ eQMS implementation- Implementation of eQMS systems including creating computer validation plans, assisting in testing of the system, and creating procedures for users, maintenance, and security of the system- Experience with hosting and interacting with regulatory authorities during an inspection**Requirements**:- 10 years of experience in a GMP/ QMS role within the CRO, Pharma, or Biotech industry- Bachelors Degree in a scientific, medical or clinical discipline- Expert knowledge of scientific principles and concepts- Hands-on experience with clinical trial and pharmaceutical development preferred- Good communication skills and willingness to work with others to clearly understand needs and solve problems- Excellent problem-solving skills- Good organizational and communication skills- Familiarity with current ISO 9001 and ISO 27001 standards preferred- Familiarity with 21 CFR Part 11, FDA, and GCP requirements- Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development processlSf9wmtNqf