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Quality Assurance Manager
hace 2 meses
Job Title: Quality Assurance Manager
Job Summary:
Gilead Sciences is seeking a Quality Assurance Manager to join our European Product Distribution and Quality team. As a Quality Assurance Manager, you will be responsible for ensuring the quality of our products and services, and for developing and implementing quality management systems.
Key Responsibilities:
- 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.
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):
Gilead Sciences, Inc. and its subsidiaries and affiliates are equal opportunity employers and welcome applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees, and we prohibit discrimination based on any protected characteristic or prohibited ground.
