Manager, Quality Systems
Bristol Myers Squibb
4 months ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Establish, maintain, and continuously improve RayzeBio’s Quality Management System (QMS) in accordance with policies, standards, procedures, and global cGMPs.
- Maintain oversight and support for quality system activities across systems such as the electronic Document Management System, electronic Quality Management System, and laboratory system interfaces.
- 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 site/global systems.
- Review and approve documents, change controls, and protocols related to QMS systems.
- 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 and ensure appropriate team member assignment.
- Identify and report discrepancies from required work practices/procedures.
- Lead cross-functional quality system initiatives and contribute to departmental quality objectives.
- Apply AI to improve team execution and decision-making.
Qualifications:
- Bachelor’s degree in engineering or a life/physical science field (including biology, biochemistry, chemistry) required.
- Minimum 5 years of work experience in Quality Assurance.
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
- Demonstrated leadership, interpersonal, communication, and motivation skills; excellent writing and oral communication skills.
- High attention to detail; sound judgment and prioritization/organization skills.
Benefits (as stated):
- Health coverage (medical, pharmacy, dental, vision), wellbeing support programs, financial wellbeing/protection (401(k), disability, life insurance, etc.), and paid time off.
- Work-life benefits include flexible time off/vacation, paid national holidays, and additional time off based on eligibility.
Application instructions:
- Not provided in the included job description text.
- Establish, maintain, and continuously improve RayzeBio’s Quality Management System (QMS) in accordance with policies, standards, procedures, and global cGMPs.
- Maintain oversight and support for quality system activities across systems such as the electronic Document Management System, electronic Quality Management System, and laboratory system interfaces.
- 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 site/global systems.
- Review and approve documents, change controls, and protocols related to QMS systems.
- 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 and ensure appropriate team member assignment.
- Identify and report discrepancies from required work practices/procedures.
- Lead cross-functional quality system initiatives and contribute to departmental quality objectives.
- Apply AI to improve team execution and decision-making.
Qualifications:
- Bachelor’s degree in engineering or a life/physical science field (including biology, biochemistry, chemistry) required.
- Minimum 5 years of work experience in Quality Assurance.
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
- Demonstrated leadership, interpersonal, communication, and motivation skills; excellent writing and oral communication skills.
- High attention to detail; sound judgment and prioritization/organization skills.
Benefits (as stated):
- Health coverage (medical, pharmacy, dental, vision), wellbeing support programs, financial wellbeing/protection (401(k), disability, life insurance, etc.), and paid time off.
- Work-life benefits include flexible time off/vacation, paid national holidays, and additional time off based on eligibility.
Application instructions:
- Not provided in the included job description text.