Regulatory Affairs

Senior Manager, Clinical Quality Assurance (XX21-290)

Catalyst Biosciences is seeking an accomplished individual for the role of Senior Manager, Clinical Quality Assurance. 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, the Protease Medicines company

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a pre-clinical C3-degrader program partnered with Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and C4b-degraders designed to target disorders of the classical complement pathway as well as other complement programs in development.

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.
  • 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 and ensuring timely closure of action items.
  • Provide guidance for key clinical systems, such as TMFs and document management.
  • Monitor current and projected clinical quality issues and contribute to continuous 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.

**Title/Level to commensurate with educational and professional experience.

Requirements

  • Minimum of 5 years of Clinical Quality Assurance experience in pharmaceutical and biotechnology.
  • Experience in leading/managing audits of clinical vendors for regulatory requirements, ICH GCP, and industry standards/best practices.
  • Experience in leading audits of clinical/medical, bioanalytical, and genetic testing laboratories preferred.
  • RN or BS/BA degree in Life Sciences preferred.
  • Comprehensive understanding of GCP/GLP regulations and guidance.
  • Must have 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 (XX21-290) in the subject line.

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