LifeSouth Community Blood Centers is currently seeking an individual for the Director of Quality Assurance position in Gainesville, FL. This position is responsible for ensuring organizational compliance with applicable regulatory requirements, accreditation standards (FDA, CLIA, AABB, state, international), and industry practice.

Responsibilities include, but are not limited to:

• Maintain LifeSouth’s Quality Assurance policies and procedures

• Provide oversight for quality and regulatory performance; sustain a culture of quality

• Provide quality management consultation to Operations, providing subject matter expertise, education and advice on cGMPs as well as process improvement

• Provide regulatory updates, report quality performance indicators and communicate significant potential compliance risks to executive staff

• Maintain federal, state and applicable licenses/accreditations

• Maintain a system-wide self-assessment program including scheduled and for-cause audits

• Monitor blood component and operational equipment quality control

• Oversee external inspections and assessments; approve responses and corrective/preventative action plans

• File interim, annual and as needed reports to the FDA; maintain blood establishment registration and product listings for all LifeSouth locations; submit biological license supplement requests as needed

• Monitor the laboratories’ proficiency testing programs

• Maintain a supplier qualification program for critical supplies, equipment and services

• Monitor process deviations, non-conformances and transfusion complications; initiate corrective action/preventative action plans as needed

• Provide regulatory review/QA approval of standard operating procedures

• Review and approve document control and record-keeping systems

• Serve as Quality Management Supervisor for the LifeCord cord blood program

• Manage Quality Assurance staff

Minimum Qualifications:

• Bachelor’s degree in medical technology, management or science related field

• Valid driver's license. Must also meet and maintain LifeSouth driver's eligibility requirements

• Willingness and ability to travel

• Must demonstrate strong leadership and oral and written communication skills

• Ability to work in a variety of physical environments

• Ability to perform root-cause analysis and problem solve

• Ability to take initiative in developing policy, procedures and projects

• Ability to make decisions consistent with regulation, standard operating procedure and manufacturer guidelines

• Ability to manage multiple tasks and prioritize multiple demands

The ideal candidate will possess:

• Medical Technologist (MT) license

• ASQ certifications

• Experience in the quality operations of a blood bank, plasma center or biotechnology related organization

This is a full-time position. Starting salary range is $90,000 - $99,000 annually. Background check and drug test required. Equal Opportunity/Affirmative Action Employer/DFWP/Tobacco Free.

The position description may not include all the duties and responsibilities of the job. Duties and responsibilities that are not listed, but which the employee may be expected to perform, will fall within the scope of the skills, knowledge and training for the position. LifeSouth is a Drug-Free and Tobacco-Free Workplace. LifeSouth is a VEVRAA Federal Contractor as well as an affirmative action employer and provides equal opportunity to all persons, regardless of race, religion, age, gender, disability, status as a protected veteran, national origin, color, or any other classification in accordance with federal, state, and local statutes, regulations and ordinances. Veterans are encouraged to self-identify as LifeSouth desires to provide protected veterans priority referrals for open positions. LifeSouth complies with all laws and regulations associated with the Family Medical Leave Act (FMLA). If you require any assistance to complete the application process or during the interview due to a disability, please contact the LifeSouth region where you are applying or call 1-888-795-2707 to request an accommodation. If you have questions regarding the information contained in this job posting call 1-888-795-2707 and ask to speak to the Talent & Recruitment Coordinator. Applications may be completed at a LifeSouth facility or mailed to corporate headquarters in lieu of the on-line application process.