Quality Assurance Manager
hace 1 día
Gilead Sciences, Inc. is seeking a highly skilled Quality Assurance Manager to join our European Product Distribution and Quality team. As a key member of our team, you will be responsible for ensuring the quality of our products and services, while also collaborating with our Commercial operations to manage relationships with external suppliers and partners.
Key Responsibilities:- Perform selection audits and qualify compliance to qualification requirements.
- Assist in the management of apheresis and treatment center qualification processes.
- Collaborate with Commercial operations to manage relationships with external suppliers and partners.
- Manage quality agreements with external suppliers and partners.
- Assess and approve changes to apheresis collection module, cell order tracking, and order processing systems.
- Maintain monitoring schedules and approved lists.
- Assist with resolution of issues and discrepancies, and investigations to resolve issues.
- Support inspection readiness plans and interact with regulatory agencies during inspections.
- 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.
- 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.
Gilead Sciences, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees. If you are a motivated and detail-oriented individual who is passionate about quality assurance, we encourage you to apply for this exciting opportunity.
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