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 state .

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

Core Competencies

Role fit

Core Competencies

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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 relationships with external suppliers and regulatory agencies while maintaining quality records and supporting inspection readiness.

Highest-signal resume keywords

Quality Assurance ExperienceGMP ComplianceRegulatory 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 ManagementApheresisClinical ResearchAuditingChange ControlCorrective Preventive ActionsSupplier ManagementMonitoring ComplianceRisk-Based QualificationData Analysis

Soft Skills

Excellent Communication SkillsDetail-OrientedSelf-MotivatedAbility to MultitaskAdaptability

Tools & Technologies

GVaultMS WordMS ExcelMS PowerPoint

Certifications & Qualifications

ASQ Certified Quality Auditor

Industry Keywords

Medical EnvironmentPharmaceutical EnvironmentBlood BanksPlasma CentersApheresis/Transplant/Infusion CentersFACT StandardsAABB StandardsInspection ReadinessQuality RecordsATC Management

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 state
Assist in managing the apheresis and treatment center qualification process using risk-based tools for qualification, training, monitoring, and disqualification
Collaborate with Commercial Operations on routine management of ATC relationships
Collaborate with Supply Chain on courier qualification and monitoring processes
Perform audits and qualify and monitor compliance with qualification requirements
Maintain the monitoring schedule and approved ATC list
Assist with resolution of ATC and courier issues and discrepancies and investigations
Support and/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
Interact with regulatory agencies during inspections on ATC-related matters as needed

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 Master's 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, development of corrective preventive/actions and change control, preferred
ASQ Certified Quality Auditor preferred
Strong working knowledge of and ability to apply 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 and able to adjust workload based upon changing priorities
Ability 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
Reasonable accommodation support for applicants with disabilities