Senior Manager, Quality Management Systems

Role Summary

Senior Manager, Quality Management Systems responsible for building, managing, and administering CRISPR’s Quality Management System, specifically Deviation, Change Control and CAPA processes. Administers Kivo QMS and ensures compliance with established procedures. Enhances existing procedures and creates new best practices.

Responsibilities

• Lead the QMS Program, specifically the deviation, CAPA, and change control programs
• Develop, improve, and administer the QMS Program
• Act as Kivo QMS business administrator
• Provide subject matter expertise to improve the QMS
• Develop and improve Quality department procedures
• Train new users on Kivo QMS
• Ensure compliance with approved CRISPR procedures as they relate to the creation and approval of QMS records
• Coordinate periodic review of QMS records
• Generate metrics to ensure on-time record closure and identify corrective actions
• Develop and present QMS metrics to management
• Create best practices for authoring technical investigations, root cause analysis tools, and corrective and preventive actions
• Meet with QMS record owners and participants to ensure proper system usage
• Support internal and external audits related to the QMS
• Enhance the Quality Culture by being a proactive and professional resource for the business

Qualifications

• Minimum of 10+ years‚Äô experience in related Biopharmaceutical QMS roles
• Experience in Biopharmaceutical QA and/or Quality System improvement roles is preferred
• BA or BS is preferred though long-time experience in QA may be acceptable
• Strong organizational skills and attention to detail
• Strong interpersonal skills
• Computer skills and previous experience with eQMS
• Ability to provide subject matter expertise regarding QMS implementation and administration
• Systems Administration experience

Preferred Qualifications

• MS or advanced degree
• Experience with Gene Therapy / Cell Therapy products
• Previous experience with Kivo QMS
• Computer System validation experience
• Entrepreneurial and results driven
• Project Management experience
• MS Office proficiency

Skills

• Collaborative ‚Äì Openness, One Team
• Undaunted ‚Äì Fearless, Can-do attitude
• Results Orientation ‚Äì Delivering progress toward our mission. Sense of urgency in solving problems
• Entrepreneurial Spirit ‚Äì Proactive. Ownership mindset

Additional Requirements

Remote flexibility balanced with on-site work; certain lab-based and manufacturing positions are fully on-site.