Quality Systems Manager (AH19-195)

Catalyst is focused on developing novel medicines to address serious medical conditions for patients who need new or better treatment options. We used a scientific approach focused on protease-based therapeutic candidates to build a clinical-stage biopharmaceutical company whose current mission is to develop valuable therapies for patients with hemophilia. 

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.