Manager, Quality Systems

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. This position will help ensure QMS systems are designed, setup, and function in a GMP-compliant manner.

Responsibilities

• Maintains and provides oversight and support for activities using the various Quality Systems utilized at RayzeBio such as the electronic Document Management System, electronic Quality Management System, or interfaces with laboratory systems.
• Collaborates with stakeholders to develop appropriate actions to resolve quality system issues.
• Oversees quality system process support and compliance, not technical system administration.
• Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems.
• Reviews and approves documents, change controls, and protocols related to QMS systems.
• Provides governance, oversight, and approval of deviation investigations related to quality systems.
• Drafts, reviews, and edits SOPs, process flow and other business documentation.
• Manages project activities and ensures appropriate team members are assigned to appropriate activities.
• Identifies and reports discrepancies from required work practices or procedures to management.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Leads cross‑functional quality system initiatives and contributes to departmental quality objectives.
• Additional Quality Systems responsibilities consistent with role scope.
• Applies AI to improve team execution and decision‑making.

Education and Experience

• At minimum, a bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is 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 are required.
• Previous work responsibility, which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Physical Demands and Work Environment

• While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear.
• The employee must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision and distance vision.
• This is a position that requires working in a laboratory environment; protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
• The position may require occasional travel, but not more than 5%.
• The noise level in the work environment is usually moderate.

Compensation

Indianapolis - RayzeBio - IN: $124,449 - $150,803. The starting compensation range is for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees). Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day.

This response is AI-generated, for reference only.