Manager/Senior Manager, Quality Systems

Position Summary

This position will report to the Director, Quality.   The position will manage the company’s quality systems and assure that Geron quality systems are both comprehensive and compliant with cGxP.

Responsibilities

  • Responsible for the oversight and direct management of Geron quality systems including vendor management, audits, document control, change control, deviations, and CAPA systems
  • Support the start-up, implementation, and operation of company’s EQMS system
  • Design, operate and maintain electronic systems for deviations, CAPA, and change control, including tracking, monitoring of review and approval cycles, and record review and approval status
  • Participate in both internal and external audits as necessary
  • Represent Quality in the creation and presentation of management review metrics.
  • Coordinate and perform training of end users in Geron’s quality systems.
  • Collaborate cross-functionally with Geron’s GxP functional groups to ensure the Quality Systems are maintained in a state of compliance.
  • Responsible for assuring alignment of company systems and policies with external 3rd part vendors (CROs and CMOs), including quality systems interfaces

MINIMUM QUALIFICATIONS

  • BA or BS in biotech/pharma-applicable field.
  • 10+ years pharmaceutical industry experience in quality systems management
  • Solid knowledge of US CFR, EU regulations, and ICH/GCP guidance governing quality systems
  • Working knowledge of regulated documents, such as non-clinical, clinical, and CMC, and their integration into regulatory submissions
  • Detail oriented with excellent organizational skills
  • Ability to work in a small biotech culture, interact successfully across multiple disciplines and at all levels of the organization
  • Experience in oncology clinical trials pereferred
  • Computer skills in MS Office applications and advanced skills with Veeva Quality Docs and other related platforms
  • Comfortable interacting and managing 3rd party vendors