Manager, Quality Systems
Bristol Myers Squibb
5 days ago
On-site
Indianapolis, IN
Operations
Summary
The Quality Systems Manager is responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) in accordance with RayzeBio policies, standards, procedures, and global cGMPs to ensure GMP-compliant QMS design, setup, and functioning.
Responsibilities
- Provide oversight and support for RayzeBio quality systems (e.g., electronic Document Management System/QMS and laboratory system interfaces).
- Collaborate with stakeholders to resolve quality system issues.
- Oversee quality system process support and compliance (not technical system administration).
- Provide input and quality approvals for validation documentation for enterprise/site/global systems.
- Review/approve QMS documents, change controls, and protocols.
- Govern/oversee/approve deviation investigations related to quality systems.
- Draft, review, and edit SOPs, process flows, and other business documentation.
- Manage project activities and ensure proper assignment of team members.
- Identify and report discrepancies from required work practices/procedures.
- Make sound decisions using judgment and notify management appropriately.
- Lead cross-functional quality system initiatives and support departmental quality objectives.
- Apply AI to improve execution and decision-making.
Qualifications
- Bachelor’s degree in engineering or life/physical science (e.g., biology, biochemistry, chemistry).
- 5+ years of Quality Assurance experience.
- Knowledge of US, EU, and global cGMP regulations/guidance.
- Demonstrated leadership, interpersonal, and communication skills; excellent writing and oral communication.
- High attention to detail; strong judgment; prioritization/organization skills.
Benefits (high level)
Health coverage; 401(k) and insurance benefits.
Physical/Work Requirements (high level)
Laboratory work with protective clothing/gloves/safety glasses for radioactive materials; occasional travel (≤5%).
The Quality Systems Manager is responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) in accordance with RayzeBio policies, standards, procedures, and global cGMPs to ensure GMP-compliant QMS design, setup, and functioning.
Responsibilities
- Provide oversight and support for RayzeBio quality systems (e.g., electronic Document Management System/QMS and laboratory system interfaces).
- Collaborate with stakeholders to resolve quality system issues.
- Oversee quality system process support and compliance (not technical system administration).
- Provide input and quality approvals for validation documentation for enterprise/site/global systems.
- Review/approve QMS documents, change controls, and protocols.
- Govern/oversee/approve deviation investigations related to quality systems.
- Draft, review, and edit SOPs, process flows, and other business documentation.
- Manage project activities and ensure proper assignment of team members.
- Identify and report discrepancies from required work practices/procedures.
- Make sound decisions using judgment and notify management appropriately.
- Lead cross-functional quality system initiatives and support departmental quality objectives.
- Apply AI to improve execution and decision-making.
Qualifications
- Bachelor’s degree in engineering or life/physical science (e.g., biology, biochemistry, chemistry).
- 5+ years of Quality Assurance experience.
- Knowledge of US, EU, and global cGMP regulations/guidance.
- Demonstrated leadership, interpersonal, and communication skills; excellent writing and oral communication.
- High attention to detail; strong judgment; prioritization/organization skills.
Benefits (high level)
Health coverage; 401(k) and insurance benefits.
Physical/Work Requirements (high level)
Laboratory work with protective clothing/gloves/safety glasses for radioactive materials; occasional travel (≤5%).