Manager, Quality Assurance – Western U.S., Florida

This is a fully remote position, open to applicants in Florida.

📋 Description

• Evaluate and authorize modifications to Kite Konnect, courier tracking, order intake, and order processing systems to uphold a validated system state.

• Assist in overseeing the apheresis and treatment center qualification process utilizing risk-based tools for qualification, training, monitoring, and disqualification.

• Collaborate with Commercial Operations for the routine management of ATC relationships.

• Work in conjunction with Supply Chain on the qualification and monitoring processes for couriers.

• Conduct audits and assess compliance with qualification requirements.

• Maintain the monitoring schedule and the approved ATC list.

• Aid in resolving ATC and courier issues, discrepancies, and investigations.

• Support and/or manage quality records, including ATC records, deviations, CAPA, and change control activities.

• Assist in the development, implementation, and management of the ATC management system (GVault).

• Support plans for inspection readiness.

• Interact with regulatory agencies during inspections related to ATC matters, as necessary.

⛳️ Requirements

• Must currently reside in the Western U.S. (west of the Mississippi) or Florida at the time of application.

• Bachelor's Degree with Six Years of Experience OR Master's Degree with Four Years of Experience OR PhD / PharmD.

• Preferred: Bachelor's degree in biological sciences, nursing, medical technologist, or a related field.

• Eight years of progressive experience in a medical or pharmaceutical setting, particularly in nursing, apheresis/transplant/infusion centers, or blood banks; OR in pharmaceutical, vaccines, or biologics quality systems roles.

• A minimum of 3-5 years of quality assurance experience is preferred.

• Experience in managing external suppliers, blood banks, and plasma centers.

• Preferred experience in medical center or pharmaceutical auditing.

• Experience in Clinical Research, Medical Liaison, Apheresis, Cell Therapy Lab, and Medical Centers is preferred.

• Prior experience in deviation management, development of corrective and preventive actions, and change control is preferred.

• ASQ Certified Quality Auditor certification is preferred.

• Strong understanding of and ability to apply GMP and FACT/AABB standards.

• Previous experience presenting to and responding to regulatory agency or certification audits is preferred.

• Proficient in MS Word, Excel, and PowerPoint.

• Excellent interpersonal, verbal, and written communication skills.

• Comfortable in a fast-paced small company environment with minimal supervision and adaptable to changing priorities.

• Ability to work independently, multitask, and prioritize job responsibilities.

• Self-motivated, detail-oriented, and open to taking on temporary responsibilities outside of the initial job description.

• Willingness to travel up to 40%.

🏝️ Benefits

• Discretionary annual bonus.

• Discretionary stock-based long-term incentives.

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.

• Reasonable accommodation support for applicants with disabilities.