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Quality Assurance Manager #49-09
The Population Council is seeking an experienced professional to be responsible for all activities involving quality assurance and compliance with applicable regulatory requirements for clinical trials within the Population Council. The successful candidate for the Quality Assurance Manager position will conduct audits and review and analyze data and documentation.
RESPONSIBILITIES:
1. Interact with program directors in identifying studies/clinics worldwide that are Good Clinical Practice (GCP) audit candidates.
2. Perform audits of GCP compliance at Population Council clinical trial sites worldwide as requested by Population Council management.
3. Prepare audit plans and post-audit reports.
4. In collaboration with program directors, clinical trial coordinators and project directors, conduct qualification visits to select appropriate clinical trial sites.
5. May, at the request of the Drug Safety Unit, participate in the investigation of Serious Adverse Events (SAEs) at the clinical sites.
6. Prepare Population Council investigational sites for inspection by the Food and Drug Administration (FDA) and other international regulatory agencies.
7. Develop solutions and implementation schedules where GCP problems exist at clinical trial sites (post-audit follow up).
8. Work with all Council staff to achieve GCP compliance in-house and at clinical trial sites (including training as needed).
9. Participate in FDA or other regulatory body inspections to provide information on GCP/GMP procedural issues as needed.
10. Prepare or participate in the development of Council-wide or CBR SOPs.
11. Ensure that GMP Quality Assurance programs at CBR are in compliance with regulatory agencies.
12. Complete Quality Assurance review and approval of clinical trial test articles.
13. Interact with the Council GMP and legal representatives regarding the quality aspects of contract manufacturing (quality agreements).
14. Participate in FDA meetings as necessary.
15. Rely on experience, judgment supervisory guidance to plan and accomplish goals.
QUALIFICATIONS:
1. Bachelor's degree (Master’s degree preferred) in a life science with five or more years of experience as a quality professional in the biopharmaceutical industry.
2. Demonstrated knowledge of standard concepts, practices, and procedures (GCP, GLP, GMP) is necessary, as is a working knowledge of and experience within one of the practice areas.
3. Working knowledge of FDA regulatory requirements.
4. Demonstrated experience in using good judgment to plan and accomplish goals.
5. Excellent interpersonal and cross-cultural communication skills.
6. Excellent organizational skills with keen attention to detail. Ability to work independently, prioritize, and to follow-up on multiple tasks simultaneously.
7. Excellent English language skills (oral and written). Fluency in a language or languages of the Council’s region(s) a plus.
8. Proficiency in MS Word, Excel, and Outlook. Proficiency in PowerPoint and Access highly preferred.
To apply please send a resume and letter of interest in Word or PDF format referencing job #49-09 to jobs@popcouncil.org or fax to 212-327-7678. Applications may also be sent to the HR Specialist, Population Council, 1230 York Avenue, New York, NY 10065. For a full job description and general information please go to http://www.popcouncil.org.
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Position Type:
Employee
Ref Code: 49-09 |
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