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Job Title: Manager, Quality Assurance
Description:
The Manager, Quality Assurance reports to the Director, Quality Assurance and provides quality assurance support (US and EU) for Cougar's assigned development drug candidate(s).
The Manager's responsibilities include the following:
- Planning and conducting GCP audits of sponsored clinical trials, CROs, clinical laboratories, internal processes, databases and clinical study reports as necessary
- Providing timely written reports to inform management of regulatory compliance status based on audits of CROs, investigator sites and internal audits of GXP processes
- Assessing and communicating compliance risk to management
- Management of Cougar's Quality System, including assisting in the development, processing and maintenance of GXP Policies (POL), Standard Operating Procedures (SOP), and Business Practices (BP)
- Assisting in managing and resolving investigation question(s) from in-house and field CRA's and bringing closure to the question(s)
- Participating in training on policies, SOP, BP and ICH/GXP regulations
- Updating and tracking all GXP audits
- Performing QC review of regulatory documents in support of submission to regulatory authorities
The Manager is accountable for sites selected for auditing; audit timing and execution; selection of audit members and inspections to ensure regulatory compliance; and release of clinical trial material.
Qualifications:
- A BS degree in a technical discipline, with a minimum of 2-4 years experience in the biopharmaceutical industry in at least two GXP areas
- Experience auditing at least one, or preferably all, of the following: clinical sites, CROs, clinical laboratories, clinical study reports and internal systems
- Experience and knowledge of GXP, ICH Guidelines, federal regulations and guidelines
- Excellent written/oral communication skills and a strong familiarity with Microsoft Office software applications
- Experience working in a document control system
- Experience reviewing Master Quality Agreements (MQA), clinical protocols, informed consents and laboratory data in a GXP environment
- Travel approximately 25%
Compensation:
Commensurate with experience
Date Posted: 11/26/2007
Email Résumé to info@cougarbiotechnology.com
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
