If you are a quality assurance professional looking to make an impact and provide leadership to a rapidly growing CRO, please read the position below!:
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Lead CQI initiatives to comply with established standards such as Good Clinical Practice (GCPs) requirements, Standard Operating Procedures (SOPs), and FDA regulations
2. Compliance reporting to relevant agencies
3. Drive completion of quality compliance plans and provide quality metrics to executive management
4. Conduct internal QA audits to identify non-compliance related to Neri's QMS in adherence to SOPs, regulations, and GCPs.
5. Lead, support and/or assist staff in client audits (e.g. vendor qualification) and/or regulatory inspections [e.g. biomedical monitoring (BIMO)]
6. Conduct and/or support and/or conduct external supplier/vendor qualification and audit activities
7. Conduct and/or support investigative site audit activities
8. Train as required to internal staff on NERI's Quality Systems and SOP's
9. Participate in drafting/revising QA and corporate SOPs
10. Compliance with NERI SOP's, Good Clinical Practices and EN ISO 9001/ISO 13485 and applicable
11. Communicate necessary information to teams, organization, and external clients
- Bachelor's in science-related field
- At least 5 years clinical trial auditing and clinical QA experience
- In-depth knowledge/experience in application of good clinical practice (GCP) requirements (ICH, FDA, etc)
- In-depth knowledge/experience in GCP auditing activities and evidence of monitoring compliance with SOPs,GCP, and FDA
- Strong written and verbal communication skills, organizational, analytical problem solving, and conflict resolution skills
- Ability to work independently and to work interactively with multidisciplinary teams to facilitate results
- At least 3 years of experience in QA practices and procedures
- CQA certification
This position can be either full time or part time with flexible hours. Majority of your time will be working in our offices but up to 20% travel possible.
New England Research Institutes (NERI) was founded in 1986 and has grown to become a clinical research organization with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques.
NERI's growth and success has been driven by strong leadership, disciplined attention to scientific integrity, and its ability to attract and retain exceptionally talented staff members. The depth of experience, skill, and expertise that the entire NERI staff brings to each project is what sets NERI apart from other research organizations and is what continues to propel NERI through the 21st century.
If interested, visit us at www.neriscience.com
NERI is an Equal Opportunity Employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identify and expression, age, disability, Vietnam era or other eligible veteran status, or any other protected factor. NERI is a VEVRAA Federal Contractor.
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