Document Manager and Systems Administrator

Employer
Kezar Life Sciences, Inc.
Location
94080, South San Francisco
Posted
Feb 18, 2021
Required Education
High School or equivalent
Position Type
Full time

Kezar Life Sciences (NASDAQ: KZR), a clinical stage biopharmaceutical company, is seeking a Document Manager and Systems Administrator. The Document Manager and Systems Administrator will report to the Sr. Director, Regulatory Affairs and will be responsible for management of and document maintenance within various systems, along with supporting activities, including document control, change control associated with the systems, controlled documents, and training documentation. The role is responsible for archival and maintenance of all regulatory, clinical, and quality documentation necessary for adequately maintaining the trial master file.

Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezar’s first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is entering Phase 1 clinical trials in several oncology indications.

Responsibilities

  • Manage the Document Control Process for the release, approval, distribution, maintenance, retrieval, and storage of clinical, regulatory, and quality system documents and records
  • Manage review and approval workflows within the system
  • Organize and maintain repository for applicable documents, including proper document classification and version control within the system
  • Maintain training records for GXP personnel
  • Develop system work-instructions and deliver training as appropriate
  • Archival and maintenance of all regulatory documentation, including health authority submission-relevant documents, study reports, and correspondence
  • Manage change control for periodic updates to EDMS
  • Assist with the development and maintenance of standard operating procedures
  • Assist in the identification of potential future systems and tools to support evolution of the systems
  • Assist in the implementation of new systems and the migration of documents into the system
  • Assist with and complete other responsibilities as assigned by management

Requirements

Minimum Qualifications:

  • Minimum 5+ years of document handling experience
  • Preferred Bachelor's degree
  • Experience with Veeva EDMS, eTMF, Box, and DocuSign preferred
  • Familiarity with ICH and FDA guidelines, GMP/GCP regulations, and quality compliance requirements preferred
  • Familiarity with eCTD structure and associated documents preferred
  • Excellent organization skills
  • Excellent attention to detail and customer service attitude
  • Self-starter with ability to work independently under pressure and react quickly to changing priorities
  • Accept change in responsibilities, as needed, typical of a small company environment
  • Willingness to learn new skills, as assigned