Quality Assurance Manager for European Product Distribution
hace 6 días
About the Role
As a Quality Assurance Manager in our European Product Distribution and Quality team, you will be responsible for ensuring compliance with qualification requirements.
Main Responsibilities
- Perform selection audits, qualify and monitor compliance to qualification requirements.
- Assist in the management of an apheresis and treatment center qualification process that uses risk-based tools for qualification, training, monitoring and disqualification.
- Collaborate with our Commercial operations in the routine management of apheresis and treatment center relationships and Supply Chain for courier qualification and monitoring processes.
- Manage quality agreements with apheresis and treatment centers.
- Assess and approve any changes to apheresis collection modules, cell order tracking, and order processing systems to maintain validated state.
- Maintain monitoring schedules and approved apheresis and treatment center lists.
- Assist with resolution of apheresis and treatment center and courier issues and discrepancies, and investigations to resolve the issues.
- Support inspection readiness plans and interact with regulatory agencies during inspections on apheresis and treatment center-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 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.
- 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 on changing priorities.
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates to recruit, select, and employ the most qualified persons available for positions throughout the Company. Except where 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.
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