Director Quality Systems US Biologics

BioReliance

Location: Rockville, Maryland-Montgomery County 20850
Posted on: 10/9/2009 1:09:12 PM
Postion type: Full time
Job Code: 478
Required Education: Bachelor's Degree
Salary:

DESCRIPTION
Advance Research. Improve Life.

Across the globe, pharmaceutical and biopharmaceutical companies rely on BioReliance, a leading provider of GLP and cGMP compliant laboratory services for more than 60 years. Our testing services include analytical analysis; safety testing of bulk and final product; the manufacture and characterization of cell banks; clearance validation; and toxicology studies.

As one of the largest specialists in the growing biologics and drug development sectors in the world, we seek a variety of professionals to support our mission of ensuring the safety of our products for our customers.

Position Overview
The selected candidate will lead the Quality Assurance function of U.S. Biologics, continually improving and driving compliance to our Quality System to meet the wide ranging compliance, validation, and quality assurance requirements of our various testing services. These requirements range from non-GLP to GMP and GCP practices, mainly pertaining to Operations but also may be related to other functions such as Commercial and R&D.

REQUIREMENTS:
Education Requirements
Position requires B.A./B.S. degree in Biology, Chemistry, bio-engineering or related science. MBA is preferred.

Experience Requirements
You must have a minimum of 10 years of hands-on experience in Quality including 5 years in a senior level managerial position leading a Quality Assurance group in a life science, GMP/FDA regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics. A strong working knowledge of US and EU regulations, coupled with direct experience in communicating with US regulatory authorities is a necessity. Quality assurance experience is preferred; as is experience with a mix of regulated and non-regulated products or services. A background using common continuous improvement tools would also be considered a plus (e.g., six sigma, SPC). Leadership skills including managing change and attracting/developing talent are key. Must be available for some travel.

Apply Online
http://tbe.taleo.net/NA7/ats/careers/requisition.jsp?org=BIORELIANCE&cws=1&rid=478

Please visit www.BioReliance.com and explore our current opportunities.
Equal Opportunity Employer

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