Quality Assurance Manager

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

• 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.