Research Scientist I/II/Sr. (Open Rank) - Director, Quality Assurance (Hybrid)

Job Title: Research Scientist I/II/Sr. (Open Rank) - Director, Quality Assurance (Hybrid)
Location: Atlanta, Georgia
Regular/Temporary: Regular
Full/Part Time: Full-Time
Job ID: 258374
Location
Atlanta, GA
Job Summary
The Director, Quality Assurance (QA) is responsible for leading and developing the Quality Assurance Unit (QAU) and for ensuring adherence to Good Laboratory Practice (GLP) regulations. The Director, QA will manage a team of audit professionals responsible for quality oversight of all GLP-regulated studies as well as Post-Approval Monitoring (PAM) for the organizations' IACUC.
Responsibilities

• Monitoring current trends of regulatory agencies as they apply to pre-clinical studies and deliver proactive approach to ensure inspection readiness and high quality results to Sponsors
• Communicating regulatory updates, understanding the impact of changes on the organizations' quality system and working with Testing Facility Management (TFM) to drive change
• Providing vendor oversight to ensure GLP compliance
• Defining quality goals and strategic initiatives for the organization and working with TFM to achieve them
• Conducting functional area review to provide TFM with assessment of organizational risk to quality
• Leading experienced audit professionals and helping to define and execute goals and personnel development plans within the group while providing annual performance reviews for direct reports.
• Perform other duties as assigned.

Required Qualifications
Research Scientist I

• Bachelor's Degree in a science discipline , or related area.

Research Scientist II

• A Master's degree in a science discipline or releated field and three (3) years of relevant full-time experience after completion of that degree, or
• A Master's degree in a science discipline or releated field and five (5) years of relevant full-time experience after completion of a Bachelor's degree, or
• A Doctoral degree in a science discipline or releated field.

Senior Research Scientist

• A Master's degree in a science discipline or releated field and seven (7) years of relevant full-time experience after completion of that degree, or
• A Master's degree in a science discipline or releated field and nine (9) years of relevant full-time experience after completion of a Bachelor's degree, or
• A Doctoral degree in a science discipline or releated field and four (4) years of relevant full-time experience after completion of a Bachelor's degree.

Preferred Qualifications

• Advanced degrees (M.S., Ph.D.) desired
• RQAP-GLP or similar preferred
• Minimum of 5 years in Quality Assurance in the health care field, preferably with biologics, medical device or pharmaceutical experience preferred.
• Previous experience as a Study Director preferred.
• Diversified experience in different disciplines including ISO certification perferred.

Knowledge, Skills, & Abilities

• Command of GLP in a Medical Device research environment.
• Experience with USDA and AAALAC beneficial.
• Key leadership competencies include engagement, visibility, relationship building, conflict resolution, and the ability to influence at all levels.
• Clear track record of major accomplishments.
• Competency in interacting with FDA in a professional manner.
• Superior organizational skills; can multi-task across many projects.
• Proficient in Microsoft Office applications.

Contact Information
For additional information about this job opening, please contact Jeffrey White at jeffrey.white@t3labs.org.
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