Director of Quality,Laboratory,GLP,QC,Biotechnology,CAP/CLIA


We are currently seeking Director level candidates, with a background in Quality for a key role with an established and growing CRO/Clinical Research Organization in the Boston, MA area.

What You Will Be Doing
At this time, we are seeking a Director of Quality Assurance to provide the organization with the leadership required to develop, implement and maintain quality systems and standards that ensures the Company is in compliance with Good Laboratory Practice (GLP), clinical trial industry standards, and assists Laboratory Management in meeting CAP/CLIA regulatory requirements.

Some additional specific responsibilities will include:

Oversee the Company’s quality assurance organization to insure efficiency, quality, service, and cost-effective management of resources.

Implement programs that balance the need of the organization to meet its financial goals while maintaining its quality standards.

Plan, direct, and coordinate quality activities at the highest level of management with the help of management team.

Work as a partner with research and development during development process to establish a phased implementation strategy that meets the customer requirements.

Maintain knowledge necessary to develop and implement procedures that conform to GLP/CAP/CLIA regulations.

Manage GLP audit programs for internal and external facilities as well as vendors and sub contractors. This will include all study/project audits, any deviations, CAPA and subsequent

reporting programs that advise the study/project director of potential impact.

Direct and oversee all vendor compliance auditing.

Manage client issues and expectations.

Review and maintain all Project/Study documents for accuracy and completeness, before being sent to the Sponsor and archived.

Work with the development staff to assure that the quality level required is built into the study/project from inception.

Work with technical support personnel to conduct prototype or experimental runs for products or processes.

Work day-to-day with Research and Development and Quality Assurance under a continuous improvement philosophy.

What You Need for this Position

Qualified candidates will bring with them, similar team leadership/direction experience, experience as both a Quality Professional and leading Quality teams, as well as a degree (advanced degree preferred) in biomedical sciences, chemistry, molecular biology or relevant scientific discipline.

Additional requirements/Desired experience includes:

Experience implementing Quality systems in GLP/CAP/CLIA environments.
Strong back ground in the drug development process and phase of clinical trials
The ability to critically evaluate and troubleshoot complex problems is essential.
Experience managing a department of 5 plus staff members, ideally in a quality setting ( QA, QC, Etc.)
Strong hands on leadership and management skills.
The ability to effectively participate on multi-disciplinary teams.
The ability to absorb, digest and relate detailed scientific, quality, and regulatory information
Excellent computer skills and experience with Microsoft Office including Word, Excel, PowerPoint, Access and Microsoft Project

Please get in touch immediately for consideration.
Applicants must be authorized to work in the U.S.

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