Senior Manager, External Quality Large Molecule

Auris Health

Auris Health

Quality Assurance
Posted on Wednesday, July 26, 2023


Job Summary

  • Provide QA support for a high touch External Manufacturer, based in China. Contribute to the overall development, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecule products.
  • Act as the External Quality touch point for the site and execute on tech transfers/projects as appropriate.
  • The position requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of Quality Assurance, Quality Control and Compliance.
  • Ability to manage complex External Manufacturers. Demonstrated ability to take ownership for and lead the resolution of Quality and Compliance issues.
  • Position requires travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight.

Job Responsibility

  1. Serve as a contact point within the QA organization of other departments of both
  2. Janssen and the external manufacturer with respect to quality relevant subjects.
  3. Ensure continued supply of all products that are manufactured by the external manufacturer. The position can also be involved in the follow-up of open topics in the supply chain, logistics and planning. Specifically, in such cases, the position will interact with the ESI account manager of the external manufacturer.
  4. Lead the development of corrective action plans and monitor implementation.
  5. Ensure that all relevant QA related concerns at the external manufacturer’s sites are raised to Janssen management. Ensure that the manufacturing operations for Janssen at the external manufacturer site run smoothly from a QA point of view and in a compliant manner.
  6. Review batch documentation of products in scope prior to their release by the external manufacturer’s quality unit, unless this is delegated to the external manufacturer's quality unit and not part of the QP function.
  7. Pro-actively identify risks and potential issues and delays and, where possible, resolve them. Where resolution is not possible, escalation to the relevant level of management is necessary.
  8. Conduct quality investigations and timely provide input to support close out with a minimum impact on the supply chain.
  9. Ensure the timely supply of Product Quality Reports (PQRs) from the external manufacturer according to schedule. Carry out a documented review of PQRs
  10. Review and monitor customer complaints in the respective database. Interaction with the complaint handling department of the external manufacturer to follow-up on investigations; secondary review of serious complaints.
  11. Coordinate change control documentation and approval process.
  12. Support regulatory inspection readiness at the external manufacturer for Janssen products.
  13. Assess current quality systems and recommend improvements in order to enhance
  14. quality and reduce cycle time.
  15. Monitor trends, identify issues, recommend, and implement appropriate actions.
  16. Drive the development, writing and implementation of quality procedures
  17. Provide QA support for technology transfer and improvement of existing manufacturing processes
  18. Support JJRC inspections at the EM.
  • Manage the interaction with the EM related to Follow-Up activities.
  • Provide guidance to the EM in the development of responses.
  • Determine applicable Follow-Up Type (on-site, document review, self-certification) based upon direction from
  • the Single Point of Contact (SPoC), the actions outlined in the response, the assigned Follow-Up Strategy Classification
  • and knowledge of the EM’s activities.
  • Verify, through follow-up activities, the EMs’ completion of actions required to satisfactorily and effectively resolve
  • observations related to audits, Significant Regulatory Actions and Significant Inspections
  • Escalate significant risks identified during the follow-up process
  • Recommend proposed Follow-Up rating colors to the Sector Compliance
  • Head at the conclusion of a Follow-Up.


Job Requirements,

  • Level of education: academic
  • Work experience: 5+ years
  • Extensive (> 3 y) knowledge of GMP, specifically parenteral and/or Large Molecule experience is preferred (QA and/or production).
  • Able to connect easily, team worker, able to manage across cultures.
  • Amount of travel 10-25%
  • English mandatory, Chinese strongly preferred, other languages are a benefit.