Manager, Quality Systems

RayzeBio

Indianapolis, IN, United States
Base: $124,449 - $150,803; bonus/equity: + incenti...
On-site
Quality management system (qms) maintenance
Gmp compliance
Electronic document management system
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 activities using various Quality Systems, collaborating with stakeholders to resolve quality system issues, and overseeing quality system process support and compliance.
  • The role requires a bachelor's degree in engineering or a life or physical science related field, a minimum of 5 years of work experience in Quality Assurance, 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

Base: $124,449 - $150,803; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Quality Management System (QMS) maintenance
  • GMP compliance
  • electronic Document Management System
  • electronic Quality Management System
  • deviation investigations
  • SOP drafting and review
  • validation documentation review

Nice-to-have

  • collaboration with stakeholders
  • cross-functional quality system initiatives
  • AI for team execution

Key Requirements

  • Bachelor's degree in engineering or life/physical science
  • Minimum 5 years of Quality Assurance experience
  • Knowledge of US, EU, and rest-of-world cGMP regulations
  • Demonstrated leadership and communication skills
  • High attention to detail
  • Sound judgment in decision-making
  • Prioritization and organization skills

Work Rights

Not specified

Tailored Resume

Cover Letter