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Manager, Quality Management Job
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| Employer Name: AuditorCrossing |
SpiderID: 2458391 |
| Location: Gaithersburg, Maryland |
Date Posted: 8/26/2008 |
| Wage: |
Category: Accounting/Bookkeeping |
| Job Code: |
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Job Description:
Responsibilities include: meet with multi-functional representatives and assure appropriate representation of the department on various initiatives; present QM concerns to QMRI Management, functional areas, and external customers as required; oversees the activities of supplement staff members (mostly contract auditors) under contract with QM; works in conjunction with the Director and Associate Director to assure coordination of efforts within the department and to assure compliance throughout the drug development process; provides guidance and shares expertise with company personnel in the interpretation of clinical development regulations and Good Clinical Practice (GCP) guidelines, Quality Assurance audit conduct and reporting, training of auditors, preparation for and management of regulatory inspections; provides oversight and training of the Quality Management personnel in all aspects of the Quality Management function; involved in the day-to-day auditing functions of the department and mentors the auditors both internal and external to develop in the profession; oversight of the QM Liaisons roles and overall departmental goals and objectives; presents QM concerns to Management, functional areas, and external customers as required; provides guidance and shares expertise with personnel in the interpretation of clinical development regulations and Good Clinical Practice (GCP) Guidelines, Quality Management audit conduct and reporting, training of auditors, preparation for and management of regulatory inspections. Qualifications include: a Bachelor's degree in a Life Science; 5 years auditing experience in worldwide clinical pharmaceutical development; project and team/contractor supervisory experience of 2 years; good working knowledge of Good Clinical Practice principles, FD A regulations regarding clinical development, ICH Efficacy Guidelines, auditing techniques and governmental regulatory inspection procedures.
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: AuditorCrossing |
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| City: Pasadena |
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| State: California |
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Web Site: http://www.auditorcrossing.com
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