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, medical technologist or related field.
* Relevant experience in a medical or pharmaceutical environment, including nursing, apheresis / transplant / infusion centers, or blood banks, preferred.
* Relevant experience in 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.
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