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The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

What you'll be doing in your new role:

  • Facilitate communication and coordination among internal stakeholders across different regions to obtain the necessary documentation required for global product registrations of externally manufactured devices.
  • Oversee the end-to-end process of requesting and providing documentation, ensuring efficiency, accuracy, and compliance with regulatory requirements.
  • Work closely with regional teams to gather and organize information, addressing queries promptly and fostering a collaborative environment for documentation retrieval.
  • Work closely with the Distribution Quality Manager to develop and implement standardized approaches for the identification, on-boarding, and ongoing management of distributors.
  • Contribute to the expansion and improvement of the global distribution network by actively participating in the development and implementation of strategies that enhance the overall efficiency and quality of distributor relationships.
  • Prepare reports for management review and participate in quality improvement projects under the discretion of m Support of internal, external and supplier audit programs as well as local Health Care Compliance and EHS activities.
  • Manage externally manufactured product requests and interact with manufacturers to complete requests.
  • Support the standardized approach for distributor on-boarding, including the evaluation of their capabilities, adherence to quality standards, and compliance with local regulatory requirements .
  • Participate in internal and external audits related to distributor quality management, ensuring compliance with regulatory standards and company policies.
  • Generate regular reports on distributor performance, compliance and other key metrics, allowing for insights to support decision-making and continuous improvement initiatives.

The individual:

  • Technical Degree or Bachelor's Degree in Chemistry, Biochemistry, Biology, Pharmacy, Engineering or related.
  • Certificate in Quality Management or Regulatory Affairs preferred.
  • Previous experience in a similar position in regulated industry (Medical Devices, IVD or drugs) is ideal.
  • Independent working ability, proactivity, attention to details.
  • Demonstrated knowledge of IVD / Medical Device regulatory environments.
  • Experience in managing Quality Systems (ISO 9001 standards).
  • Fluency in English is required.

The role is based in Cairo, Egypt.

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Confirmed 9 hours ago. Posted 20 days ago.

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