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.
- 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
- 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