Clinical QA Operations Director
4 days ago
Job Title: Clinical QA Operations Director
Estimated Salary: $90,000 - $120,000 per year
We are seeking a highly experienced Clinical QA Operations Director to join our team at Frontage Laboratories Inc. in Secaucus, NJ.
The ideal candidate will have a minimum of five years of clinical research experience in a CRO pharmaceutical, biotech, medical device and other life science industries or equivalent education and experience.
Key Responsibilities:
- Conduct independent internal quality review of studies performed and ensures the conduct of clinical systems audits are performed per audit plan.
- Oversees and advises on the development of Standard Operating Procedures (SOPs), Guidelines and other tools.
- Performs external non-Frontage investigational sites audits (as needed) for compliance with GCPs and ICH guidelines, applicable FDA regulations, SOPs, and the study protocol.
- Hosts regulatory agency inspections/sponsor audits and issues responses to audit report findings after discussion with operations management.
Requirements:
- Degree in Science, Nursing, or related field.
- Strong knowledge of GCPs, ICH guidelines and FDA regulations related to Clinical Research, and experience in Clinical Quality Assurance.
- Working knowledge of the drug development process, GLPs, and GMPs.
- Computer literate in Microsoft Office, Word, Excel, and Power Point.
Benefits:
- A competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
- An equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
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