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

Gilead Sciences

. Assess and approve changes to Kite Konnect, courier tracking, order intake, and order processing systems to maintain validated system status .

Posted 10/27/2026full-timeRemote • United StatesMid-LevelSenior💰 $123,930 - $160,380 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in quality assurance within medical or pharmaceutical environments, with a strong focus on compliance with GMP and FACT/AABB standards. Proficient in managing external suppliers and conducting audits, while effectively communicating with regulatory agencies.

Highest-signal resume keywords

Quality Assurance ExperienceGMP KnowledgeRegulatory Agency InteractionDeviation ManagementASQ Certified Quality Auditor

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality Systems ManagementApheresis ManagementClinical ResearchAuditingChange ControlCAPASupplier ManagementMonitoring ComplianceRisk-Based QualificationData Analysis

Soft Skills

Excellent Communication SkillsDetail-OrientedSelf-MotivatedMultitaskingProblem-Solving

Tools & Technologies

GVaultMS WordMS ExcelMS PowerPoint

Certifications & Qualifications

ASQ Certified Quality Auditor

Industry Keywords

Medical CenterPharmaceuticalBlood BanksPlasma CentersApheresisCell TherapyInfusion CentersCompliance StandardsQuality RecordsInspection-Readiness

About the role

Key responsibilities & impact

Assess and approve changes to Kite Konnect, courier tracking, order intake, and order processing systems to maintain validated system status
Assist in managing apheresis and treatment center qualification processes using risk-based tools for qualification, training, monitoring, and disqualification
Collaborate with Commercial Operations on ATC relationships and with Supply Chain on courier qualification and monitoring
Perform audits and qualify and monitor compliance with qualification requirements
Maintain the monitoring schedule and approved ATC list
Assist with resolving ATC and courier issues and discrepancies and investigate issues
Support or own quality records, including ATC records, deviations, CAPA, and change control
Assist in developing, implementing, and managing the ATC management system (GVault)
Support inspection-readiness plans and interact with regulatory agencies during inspections on ATC-related matters

Requirements

What you’ll need

Must currently reside in the Western U.S. (west of the Mississippi) or Florida at the time of application
Bachelor’s Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience OR PhD / PharmD
Preferred: Bachelor’s degree in biological sciences, nursing, medical technologist or related field
8 years progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles
Minimum 3-5 years quality assurance experience preferred
Experience managing external suppliers, blood banks, and plasma centers
Medical center or pharmaceutical auditing experience preferred
Experience in Clinical Research, Medical Liaison, Apheresis, Cell Therapy Lab, and Medical Centers preferred
Previous experience in deviation management, corrective/preventive actions, and change control preferred
ASQ Certified Quality Auditor preferred
Strong working knowledge of GMP and FACT/AABB standards
Previous experience presenting and responding to regulatory agency or certification audits 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 direction
Must be able to work independently, multitask, and prioritize job responsibilities
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description
Ability to travel up to 40%

Benefits

Comp & perks

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