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Director of Bioanalytical Quality Assurance

Crawford Thomas Recruiting Germantown, MD

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Position Summary:
As part of the global QA leadership team, you’ll work in our fast-paced environment and contribute to our client-centric solutions in one the world's largest and most comprehensive drug development services companies.

In this role, you will lead, manage and coach a QA team ensuring compliance to quality standards through the performance of project, process-based, and facility inspections as you:

  • Audit bio-analytical (LC/MS-MS) data and technical reports
  • Act as the primary contact for clients and regulatory inspections and as the site expert for regulatory guidelines
  • Provide training to technical and professional staff on GLP regulations
  • Lead ongoing process improvements to improve best practices
  • Instill and manage a culture of continuous improvement, quality, and productivity
  • Participate in outside agency or sponsor related inspections or inquiries, as required

The qualifications of an ideal candidate include:

  • A Bachelor s degree, preferably in science or a related field
  • At least 5 years of experience in a GLP/GCP regulated environment with at least 2 years of demonstrated leadership experience
  • Advanced working knowledge of current regulatory guidelines including
    GLP
    and
    21 CFR Part 11
    and a general knowledge of
    ICH GCP
    compliance
  • Working knowledge of
    FDA Guidance for Industry, Bioanalytical Method Validation (LC/MS-MS preferred), and experience with Watson LIMs and Analyst software preferred
  • Excellent communication and interpersonal skills with the ability to influence others with impact
  • Outstanding experience with client satisfaction and problem solving solutions
  • Experience working in the CRO/Pharma industry highly preferred

If this seems like a good fit, please apply for immediate consideration!

Company Description
Crawford Thomas Recruiting is a full-service employee recruitment firm with a focus in the areas of sales, accounting and information technology. We work with industry-leading companies and experienced professionals to provide the best career opportunities and find that perfect match between job seeker and employer.

The success or failure of a company can hinge on its ability to acquire and retain key employees. When the need arises to search for talented professionals, Crawford Thomas Recruiting provides solutions that fit. We intellectually partner with organizations so that we are able to understand how their recruiting needs tie into their business objectives. With that knowledge in hand, we identify premier candidates and provide crucial information in order to achieve recruitment and organizational success.

Crawford Thomas Recruiting services Fortune 500 and Inc. 5000 companies nationwide from our headquarters in Orlando, Florida. Visit our website at www.crawfordthomas.com for all of our open positions!!

Crawford Thomas Recruiting

Crawford Thomas Recruiting is a full-service employee recruitment firm with a focus in the areas of sales, accounting and information technology. We work with industry-leading companies and experienced professionals to provide the best career opportunities and find that perfect match between jobseeker and employer. The success or failure of a company can hinge on its ability to acquire and retain key employees. When the need arises to search for talented professionals, Crawford Thomas Recruiting provides solutions that fit. We intellectually partner with organizations so that we are able to understand how their recruiting needs tie into their business objectives. With that knowledge in hand, we identify premier candidates and provide crucial information in order to achieve recruitment and organizational success. Crawford Thomas Recruiting services Fortune 500 and Inc. 5000 companies nationwide from our headquarters in Orlando, Florida. Visit our website at www.crawfordthomas.com for all of our open positions!!

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Germantown, MD
20876 USA

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