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.
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.
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