Must be able to interface effectively with internal personnel, clients, and auditors, including the USFDA, prepare proper response to any observation. Responsible for all QA functions, including but not limited to document control, releasing testing results, internal/external audits, as well as personnel training records. Responsible for all lab safety and training issues. Position requires ability to manage and supervise employees. The preparation, review and issuance of various laboratory CAPA status reports, and periodic quality trend updates. Responsible for Exception Management documentation (Deviation, LIR, CAPA, Incidents), accurately and timely performed with documented closure. Internal and external audit key contact and point person. Ensure accurate and timely planning, preparation, review and approval of responses to client audits, schedules, reports, and action plans. This position requires the ability to supervise the department and have good problem solving abilities. Create and revise departmental and test procedures, SOP's etc. Provide technical support in the maintenance of lab systems and instrumentation. Works with the management group to improve and implement the required quality systems. Works closely with QA staff to maintain and improve Quality Systems.

Requires decision-making and analysis of multiple factors in matters involving very complex issues. Demonstrated proficiency with the preparation of quality documents, ability to manage multiple projects and meet critical deadlines. Demonstrated successful interdisciplinary collaboration in a team setting. Requires a M.S. in scientific field is required (Ph.D. prefer); 10-15+ plus years experience in pharmaceutical, biotech, or medical device industry, with recent and significant experience in the contract testing laboratory industry preferred. Proven track record of success as a QA/RA director. Strong project management skills - ability to take programs from concept to execution, and manage all stages. Superb attention to detail and ability to meet deadlines. Excellent written, verbal, and communication skills. A high level of creativity. Demonstrates strong in-depth clinical, technical and scientific knowledge. Effective administrator who efficiently manages time, resources and workload. Requires decision-making and analysis of multiple factors in matters involving very complex issues. Demonstrated proficiency with the preparation of quality documents, ability to manage multiple projects and meet critical deadlines. Demonstrated successful interdisciplinary collaboration in a team setting.