Quality Assurance Specialist

hace 7 días


Madrid, Madrid, España Gilead Sciences A tiempo completo
Company Overview

Gilead Sciences is a leading biopharmaceutical company dedicated to creating innovative treatments for complex diseases. With a strong commitment to improving lives, we strive to push the boundaries of scientific research and development.

We are a dynamic and collaborative team that values diversity, inclusion, and creativity. Our employees are passionate about making a difference and driving progress in the healthcare industry.

About the Role

As a Quality Assurance Specialist at Gilead Sciences, you will play a critical role in ensuring the quality and safety of our products. This includes performing audits, qualifying and monitoring suppliers, and managing quality agreements.

You will work closely with cross-functional teams to develop and implement quality management systems, and ensure compliance with regulatory requirements.

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

To be successful in this role, you will need:

  • A 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.
Benefits

We offer a competitive salary of $120,000 - $180,000 per year, depending on experience, plus a range of benefits including:

  • Medical, dental, and vision insurance.
  • 401(k) retirement plan with company match.
  • Tuition reimbursement program.
  • Paid time off and holidays.
  • Opportunities for professional growth and development.
Location

This role is based in Europe, with opportunities for international travel up to 50%.



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