Senior Manager, Clinical Quality Assurance (CD20-238)

Catalyst Biosciences (Catalyst, CBIO) is seeking an accomplished individual for the role of Senior Manager, Clinical Quality Assurance (CQA). 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 Good Clinical Practice (GCP)/Good Laboratory Practice (GLP) regulations and guidance.

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

  • Key contributor to developing, implementing, and managing an integrated Clinical Quality Assurance program in the context of an outsourced development model
  • Develop and oversee Clinical Quality Assurance Plans, including auditing of clinical trial sites and contract research organizations, and the collection and reporting of clinical trial data
  • Ensure external GCP/GLP vendors are appropriately qualified and remain in an acceptable state of GCP compliance
  • Contribute to the development and deployment of GCP/GLP associated standard operating procedures, processes, and quality standards
  • Represent Clinical Quality Assurance on clinical study teams
  • Collaborate with clinical study teams to identify risk assessments per ICH E6(R2) and related ICH guidance (e.g., E3, E8, E9, E11) and country specific regulatory requirements, and develop associated mitigation plans
  • Interface with relevant stakeholders to provide GCP/GLP compliance advice and expertise
  • Manage an internal Clinical Quality Assurance non-conformance and CAPA program, including developing root cause analysis, performing effectiveness verification, and ensuring timely closure of CAPAs and action items
  • Provide guidance for key clinical systems, such as CTMS, LMS, TMFs, and document management
  • Monitor current and projected clinical quality issues and contribute to continuous quality improvements in GCP/GLP compliance
  • Organize and train internal staff on inspection readiness for GCP audits and support inspections by health authorities
  • Actively support the company’s cultural initiatives

REQUIREments

  • Minimum of 5 years of Clinical Quality Assurance experience and/or equivalent GCP leadership experience within the pharmaceutical, biotechnology or medical device industry (e.g., Project Manager with experience interacting with CQA personnel and overseeing quality supporting activities such as regulatory inspections and CAPA management)
  • RN or BS/BA degree in Life Sciences preferred
  • Comprehensive understanding of GCP/GLP regulations and guidance
  • Proven track record in building and managing highly efficient Clinical Quality Assurance programs
  • 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 (CD20-238) in the subject line.