Associate Director, Quality Systems (CD20-237)

Catalyst Biosciences (Catalyst, CBIO) is seeking an accomplished individual for the role of Associate Director, Quality Systems for its South San Francisco headquarters. The successful candidate will be a proven leader who will work closely with the company’s leadership team and staff to advance Catalyst Biosciences’ pipeline programs consistent with the company’s vision and in a manner compliant to regulations.

ABOUT CATALYST BIOSCIENCES

Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet medical needs in patients with rare bleeding and complement related disorders. Catalyst currently has compounds in discovery and development phases that span the value chain from the early discovery stage to late stage clinical trials with the intent of commercialization.

RESPONSIBILITIES

  • Accountable for developing, implementing, and managing a Quality System capable of supporting an outsourced development model
  • Manage the creation and maintenance of the Quality Policy, Quality Manual, and Standard Operating Procedures
  • Develop and manage an effective internal GXP training program, including tracking of staff training and the maintenance of training materials and records
  • Organize and train internal staff on inspection readiness of the Quality System and support inspections by health authorities
  • Contribute to continuous improvements in GXP compliance
  • Manage and continuously improve the supplier qualification and evaluation program including Quality Agreements
  • Develop and oversee a GXP document management system
  • Develop a Management Review program to support periodic quality status reports to the company’s leadership team on process performance and product quality
  • Develop process performance and quality monitoring system to generate quality metrics and trending analyses related to GXP compliance and Quality Systems
  • Develop and maintain an internal non-conformance and CAPA management program
  • Implement and manage GXP change management system
  • Actively support the company’s cultural initiatives
  • Implementing, configuring, validating and managing an electronic document management and QMS

Requirements

  • Minimum of 7 years Quality Systems experience in biotechnology
  • BS/BA degree in Life Sciences preferred
  • Comprehensive understanding of quality regulations applicable to Quality Systems for pharmaceutical development and commercialization
  • Proven track record in building and managing highly efficient Quality Systems
  • Must be a dynamic leader with outstanding communication skills and an ability to effectively direct subordinates
  • Demonstrated strengths in problem solving, strategic planning, and working collaboratively

 

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number (CD20-237) in the subject line.