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Director Quality Assurance & Regulatory Affairs Job
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| Employer Name: BiotechCrossing |
SpiderID: 2382499 |
| Location: Pittsburgh, Pennsylvania |
Date Posted: 7/21/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6407395 |
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Job Description:
Director Quality Assurance & Regulatory AffairsEnsures quality and completeness of company deliverables and compliance with FD A regulations and any other regulatory agencies. This position is responsible for overseeing quality and compliance for all phases of the corporation. This position is also responsible for providing direction to the company Institutional Review Board and overseeing all regulatory training aspects for the organization. The qualified candidate will lead and direct the Quality Assurance Department for multiple facilities, be responsible for planning and reviewing the activities of the Quality Assurance department to ensure that appropriate quality reviews are conducted for all areas, ensures company SOPs are in accordance with current regulatory requirements. This also includes ensuring that critical areas of operations have adequate SOPs in existence to cover the company from a regulatory standpoint. Also provides support during any regulatory inspections such as FD A , Oversees SOP training, Good Clinical Practices (GCP's) training and any other training related to FD A , and other regulatory standards and finally other duties as assigned. Qualifications include Bachelors Degree in a scientific discipline or equivalent experience, masters degree preferred. Extensive knowledge of GCP, ICH, FD A guidelines as well as other applicable regulatory requirements. 8- 10 years experience, GCP experience in clinical research preferred. At least 5 years managerial experience and the ability to travel.Please refer to job code SD5337 when responding to this ad.
For more information, please click here to visit us at BiotechCrossing
For further information, please visit us online at http://www.biotechcrossing.com
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Job Requirements:
6407395
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: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.biotechcrossing.com
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