Site Qualification Manager, Quality Assurance

Site Qualification Manager, Quality Assurance

Gilead

Amsterdam, Netherlands

You’ll be reporting to the senior director quality.

Your Responsibilities

In this role, you will work cross functionally to assist with the development and implementation of a qualification and monitoring program for medical apheresis and treatment centers that supports Kite’s rapid expansion of our first commercially marketed cell therapy product in the EU.

Your responsibilities, among others, will be:

  • Assist in management of the collection app system.
  • Assess and approve any changes to collection app, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained
  • 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.
  • Perform selection audits, qualify and monitor compliance to qualification requirements.
  • 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 management of the collection system.
  • Assess and approve any changes to collection app, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained
  • 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

Your Profile

The ideal candidate for this position is flexible, has great communication skills and feels comfortable in a fast paced environment.

Education

  • Bachelor’s degree in Nursing, biological sciences, nursing, medical technologist or related field

Knowledge/Experience

Required:

  • Relevant experience in and extensive knowledge of cGMP
  • Proficiency in English and local language
  • 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.
  • Experience managing external suppliers, blood banks, and plasma centers.

Preferred:

  • 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 presenting and responding to regulatory agency or certification audits, preferred.
  • Proficient in MS Word, Excel, and Power Point
  • Relevant experience working in multicultural and cross functional teams

Personal skills

Required:

  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Team player
  • 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.

Additional Requirements

  • Ability to travel up to 40%

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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