Job: Director of Quality Assurance (Lab Support; Towson, MD)
Our client is currently seeking a Quality Assurance Director to create and implement a quality assurance and training system for local and national compliance.
Some of the duties include (but not limited to)
* Plan, organize and implement Quality Assurance program strategies and initiatives to enable all locations to meet quality standards and ensure compliance with regulatory requirements.
* Create and revise Standard Operating Procedures for Quality System requirements and sample collection operations.
* Review and approve all documentation including SOPs, Forms, Labels and Labeling.
* Establish and maintain document control and change management system via SharePoint information sharing technology.
* Supervise training and quality staff, manage budgets for Network QA and Training.
* Supervise Quality Assurance staff.
* Provide all locations with regulatory and accreditation support. Manage FDA registrations and principal regulatory contact for all recovery locations for FDA and state licenses.
* Manage qualifications and validations of equipment and processes as required by regulations and standards.
* Maintain required communications on departmental goals, projects and associated challenges for a successful Quality System program to the Vice President and Chief Quality Officer, President/CEO, Network locations, Medical Directors, regulatory agencies, and periodic presentations to Executive Staff.
Job Requirements
Required skills:
Qualified candidates must have:
* Bachelor’s degree in a life science discipline or equivalent education/work experience in a structured regulated environment.
* Five years management experience in an FDA regulated environment (other professional experience may be considered) with 3-5 years experience in functional tissue banking
* Ability to read and interpret documents such as procedures, standards, regulations, protocols, etc. and apply to Quality and Training System.
* Working knowledge of standard PC based Microsoft Office applications.
http://www.careerbuilder.com/JobSeeker/Jobs/JobDetails.aspx?job_did=J8E0VQ733JD7HJ0N3HQ
