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

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

📋 Description

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

• Aid in overseeing apheresis and treatment center qualification procedures utilizing risk-based tools for qualification, training, monitoring, and disqualification.

• Work in partnership with Commercial Operations on ATC relationships and with Supply Chain on courier qualification and oversight.

• Conduct audits and verify compliance with qualification standards.

• Manage the monitoring schedule and maintain the approved ATC list.

• Assist in troubleshooting ATC and courier issues, discrepancies, and conducting investigations.

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

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

• Facilitate inspection readiness plans and engage with regulatory agencies during inspections concerning ATC-related issues.

⛳️ Requirements

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

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

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

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

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

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

• Preference for auditing experience in medical centers or pharmaceuticals.

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

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

• ASQ Certified Quality Auditor is preferred.

• Strong understanding of GMP and FACT/AABB standards.

• Previous experience in presenting and addressing regulatory agency or certification audits is preferred.

• Proficiency in MS Word, Excel, and PowerPoint.

• Exceptional interpersonal, verbal, and written communication skills.

• Comfortable working in a fast-paced small company environment with minimal supervision.

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

• Self-driven, detail-oriented, and open to taking on temporary duties beyond the original 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.