 |
Available Positions
|
|
» Back to Available Positions
Job Title: Manager/Senior Manager, Quality Assurance
Description:
The Manager / Senior Manager, Quality Assurance will focus on management of Cougar's internal Quality System to ensure that its policies, methods, and procedures comply with global Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) in support of the conduct of clinical research. Responsibilities include the following:
- Manage Cougar's Quality System, which includes identification of required policies and procedures to ensure GXP compliance, with an emphasis on GCP; process mapping of required process/procedures/practices with stakeholders; change control; and effective training program
- Conduct internal GCP audits of Cougar's processes and procedures to issue timely audit reports; identify compliance risks; effect required changes to ensure compliance with regulatory requirements
- Review clinical protocols, IB, and study reports for GXP compliance
- Conduct external GCP/GLP audits of sponsored clinical trials, including investigator sites, CROs, clinical laboratories and clinical databases, and issue/close out audit reports in a timely manner, as required
- Interact proactively with Clinical Operations to solve GCP compliance questions/concerns
Qualifications:
Candidates must have a minimum of a BS Degree in a technical discipline and 2-4 years experience in GCP in the biopharmaceutical industry. Required qualifications include experience auditing clinical sites, CROs, clinical laboratories, clinical study reports and/or internal systems; experience and knowledge of GCPs, GLPs, ICH guidelines, federal regulations and guidelines. GMP knowledge and demonstrated ability to establish standards in support of the quality system are a plus. Excellent interpersonal, communication and project management skills, as well as direct experience with a project management system are also required.
Compensation:
Commensurate with experience
Date Posted: 04/29/2008
Email Résumé to info@cougarbiotechnology.com
» Back to Available Positions
|
| | |
Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
