Quality Assurance Manager
hace 4 semanas
About the Role:
At Gilead Sciences, we're committed to creating a healthier world for all people. As a Quality Assurance Manager, you'll play a critical role in ensuring the quality of our products and services. This position is part of our European Product Distribution and Quality team, and you'll be responsible for performing selection audits, qualifying and monitoring compliance to qualification requirements. You'll also assist in the management of an apheresis and treatment center qualification process, collaborate with our Commercial operations, and manage quality agreements with the ATC. If you have a background in nursing, biological sciences, or a related field, and experience in a medical or pharmaceutical environment, we'd love to hear from you. As a team player with excellent communication skills, you'll thrive in our fast-paced and collaborative work environment.
Key Responsibilities:
• Perform selection audits, qualify and monitor compliance to qualification requirements.
• Assist in the management of an apheresis and treatment center qualification process.
• 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.
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.
About Gilead Sciences:
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines. We're committed to creating a healthier world for all people, and we're looking for talented individuals to join our team.
Equal Employment Opportunity:
Gilead Sciences is an equal opportunity employer and welcomes applications from diverse candidates. We're committed to creating an inclusive and diverse work environment, and we're proud to be an equal opportunity employer.
Contact Information:
Please note that we do not accept unsolicited resumes or applications. If you're interested in joining our team, please submit your application through our website.
Disclaimer:
Gilead Sciences is not responsible for any unsolicited resumes or applications.
Job ID:
J-18808-Ljbffr
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