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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
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Job Description The position is part of the European Product Distribution and Quality team. The role requires the ability to travel nationally and internationally up to 50%.
Responsibilities (include but are not limited to): Perform selection audits, qualify and monitor compliance to qualification requirements.
Assist in the management of an apheresis and treatment center (ATC) qualification process that will use risk-based tools for qualification, training, monitoring and disqualification.
Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
Manage quality agreements with the ATC.
Assess and approve any changes to apheresis collection module, cell order tracking and order processing systems to assure validated state of the systems is maintained.
Maintain the monitoring schedule and approved ATC list.
Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
Assist in development, implementation and management of ATC management system (Oracle Agile).
Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
Perform other duties as assigned.
Requirements: Bachelor's degree in Nursing, biological sciences, nursing, medical technologist or related field.
Relevant 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.
Proficiency in English, Spanish and recommended Portuguese.
Experience managing external suppliers, blood banks, and plasma centers.
Medical center or pharmaceutical auditing experience preferred.
Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
Previous experience in Quality Assurance, preferred.
Proficient in MS Word, Excel, and Power Point.
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Team player.
Relevant experience working in multicultural and cross functional teams.
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
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