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

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $123.9k - $160.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• 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

• 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

• 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