Quality Systems Manager (AH19-195)

Catalyst is a clinical-stage biopharmaceutical company focused on developing novel treatments for hemophilia and other rare bleeding disorders using our potent, subcutaneous (SQ) coagulation factors that promote prophylaxis therapy. We have completed the Phase 2 trial of our subcutaneous (SQ) Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for prophylaxis. The study met the primary endpoint of significantly reducing the annualize bleed rate (ABR) in patients with hemophilia A or B with inhibitors.  The study also met all secondary endpoints of safety, tolerability and lack of anti-drug antibody or inhibitor formation.  We have also initiated enrollment in a Phase 2b trial of dalcinonacog alfa – DalcA, a next-generation (SQ) administered Factor IX (FIX) therapy being developed for the treatment of hemophilia B.

We are currently seeking to hire a motivated Quality Systems Manager who would report to the Senior Director Quality Compliance.  

Responsibilities

  • Maintain and monitor quality system processes
  • Ensure Quality Systems conform to GMP and regulatory requirements
  • Lead audit management program
  • Lead supplier audits
  • Write, Review, and approve procedures
  • Develop, track and, communicate quality metrics
  • Manage and Support for Deviation /Change Control, and Document management systems
  • Support GxP training program
  • Provide support and quality assessments of internal and external suppliers to assess compliance risk.

Qualifications

  • Excellent communication skills (interpersonal, written and verbal)
  • Must be well organized, polished, proactive, detail-oriented, mature and have a professional demeanor
  • Ability to multi-task and work efficiently in an environment with changing priorities

Requirements

  • Bachelor of science degree with 3-5 years previous employment in the GMP biotechnology/pharmaceutical Quality Systems field
  • Experience in a start-up environment
  • Strong knowledge of GMP’s
  • Thorough knowledge of regulatory requirements as applicable for US and rest of world regions
  • Fit with Catalyst culture and values
  • Well organized and a strong attention to detail
  • Successful experience in fast-paced entrepreneurial environment

 

Please send CVs/resumes directly to Human Resources, jobs@catbio.com referencing job number AH19-195 in the subject line.