Manager, Quality Systems
Bristol Myers Squibb
4 months ago
On-site
Indianapolis, IN
Operations
Quality Systems Manager
Responsibilities
- Establish, maintain, and continuously improve the Quality Management System (QMS) in accordance with RayzeBio policies, standards, procedures, and global cGMPs; ensure QMS systems are designed, set up, and function in a GMP-compliant manner.
- Maintain and provide oversight/support for Quality Systems such as electronic Document Management, electronic Quality Management System, and interfaces with laboratory systems.
- Collaborate with stakeholders to develop actions to resolve quality system issues.
- Oversee quality system process support and compliance (not technical system administration).
- Provide input and quality approvals for validation documentation supporting enterprise and/or applicable site/globally owned systems.
- Review and approve QMS-related documents, change controls, and protocols.
- Provide governance, oversight, and approval of deviation investigations related to quality systems.
- Draft, review, and edit SOPs, process flows, and other business documentation.
- Manage project activities; ensure appropriate team member assignment.
- Identify and report discrepancies from required work practices/procedures.
- Make sound decisions using judgment within established practices/policies; notify management as appropriate.
- Lead cross-functional quality system initiatives and contribute to departmental quality objectives.
- Additional quality system responsibilities consistent with role scope.
- Apply AI to improve team execution and decision-making.
Qualifications
- Bachelor’s degree in engineering or life/physical science (including biology, biochemistry, chemistry).
- Minimum 5 years of Quality Assurance experience.
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
Skills
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication skills.
- High attention to detail; sound judgment in decision-making.
- Strong prioritization and organization skills.
Benefits (if applicable)
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support programs.
- Financial well-being and protection (401(k), disability, life insurance, and related protections).
- Paid time off (including flexible time off and paid national holidays; additional time off based on eligibility).
Application instructions
- Requisition/Job Title: R1601131 Manager, Quality Systems.
Responsibilities
- Establish, maintain, and continuously improve the Quality Management System (QMS) in accordance with RayzeBio policies, standards, procedures, and global cGMPs; ensure QMS systems are designed, set up, and function in a GMP-compliant manner.
- Maintain and provide oversight/support for Quality Systems such as electronic Document Management, electronic Quality Management System, and interfaces with laboratory systems.
- Collaborate with stakeholders to develop actions to resolve quality system issues.
- Oversee quality system process support and compliance (not technical system administration).
- Provide input and quality approvals for validation documentation supporting enterprise and/or applicable site/globally owned systems.
- Review and approve QMS-related documents, change controls, and protocols.
- Provide governance, oversight, and approval of deviation investigations related to quality systems.
- Draft, review, and edit SOPs, process flows, and other business documentation.
- Manage project activities; ensure appropriate team member assignment.
- Identify and report discrepancies from required work practices/procedures.
- Make sound decisions using judgment within established practices/policies; notify management as appropriate.
- Lead cross-functional quality system initiatives and contribute to departmental quality objectives.
- Additional quality system responsibilities consistent with role scope.
- Apply AI to improve team execution and decision-making.
Qualifications
- Bachelor’s degree in engineering or life/physical science (including biology, biochemistry, chemistry).
- Minimum 5 years of Quality Assurance experience.
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
Skills
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication skills.
- High attention to detail; sound judgment in decision-making.
- Strong prioritization and organization skills.
Benefits (if applicable)
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support programs.
- Financial well-being and protection (401(k), disability, life insurance, and related protections).
- Paid time off (including flexible time off and paid national holidays; additional time off based on eligibility).
Application instructions
- Requisition/Job Title: R1601131 Manager, Quality Systems.