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.
- 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.
- 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
- 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, email@example.com referencing job number AH19-195 in the subject line.