Quality Assurance Program Manager

Minimum Requirements:

Eight (8) years of relevant experience or an equivalent combination of education and experience

Position Description:

The University of Louisville Brown Cancer Center has an opening for a Temporary Quality Assurance Program Manager. This is a part-time (2 hrs/week) temporary position.

Position will provide Quality Assurance support for CAR-T cell and other cellular therapy manufacturing. Duties include:

• Provide oversight of GMP equipment validations, preventative maintenance, and calibrations.
• Lead, schedule, and coordinate daily priorities for incoming raw materials sampling, release, hold and inspection activities in manufacturing areas.
• Monitor and ensure all phases of cellular therapy manufacturing are in compliance with established specifications.
• Review production batch reviews for manufacturing, determine batch disposition, and monitor systems and procedures to ensure compliance with applicable regulatory and industry standards for GMP manufacturing of biological products.

Preferred Qualifications:

• Complete understanding of running a Quality Management System
• Experience reviewing and approving Validation protocols
• Experience with internal and external audits
• Experience and ability to perform listed duties
• Excellent communication skills
• 9-12 years of QA experience

Compensation will be commensurate to candidate experience.

Equal Employment Opportunity

The University of Louisville is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, sex, age, color, national origin, ethnicity, creed, religion, disability, genetic information, sexual orientation, gender, gender identity and expression, marital status, pregnancy, or veteran status. If you are unable to use our online application process due to an impairment or disability, please contact the Employment team at [email protected] or 502.852.6258.

Assistance and Accommodations

Computers are available for application submission at the Human Resources Department located at 215 Central Avenue, Ste 205 - Louisville, Kentucky 40208.

If you require assistance or accommodation with our online application process, please contact us by email at [email protected] or by phone 502-852-6258.