Manager, Quality Systems

RayzeBio

Indianapolis, IN, US
Indianapolis - rayzebio - in: $124,449 - $150,803 ...
On-site
Quality management system (qms) establishment and maintenance
Cgmp regulations knowledge
Electronic document management system oversight
The Quality Systems Manager is responsible for the establishment, maintenance, and continuous improvement of the QMS in accordance with RayzeBio policies, standards, procedures and global cGMPs

Job Summary

  • The Quality Systems Manager is responsible for the establishment, maintenance, and continuous improvement of the QMS in accordance with RayzeBio policies, standards, procedures and global cGMPs.
  • Essential duties include maintaining and providing oversight for quality systems, collaborating with stakeholders to resolve issues, and providing input and quality approvals for validation documentation.
  • The role requires a bachelor's degree in a relevant field, a minimum of 5 years of QA experience, and knowledge of US, EU, and rest-of-world cGMP regulations.

Matching Summary

The Quality Systems Manager is responsible for the establishment, maintenance, and continuous improvement of the QMS in accordance with RayzeBio policies, standards, procedures and global cGMPs.

Salary

Indianapolis - RayzeBio - IN: $124,449 - $150,803

Skills & Requirements

Must-have

  • Quality Management System (QMS) establishment and maintenance
  • cGMP regulations knowledge
  • Electronic Document Management System oversight
  • Deviation investigation governance
  • SOP drafting and review

Nice-to-have

  • AI application for team execution
  • Transformative radiopharmaceutical therapies development
  • Nimble, pioneering spirit

Key Requirements

  • Bachelor's degree in engineering or life/physical science
  • Minimum 5 years of work experience in Quality Assurance
  • Knowledge of US, EU and rest-of-world cGMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter