Manager, Quality Systems

Bristol Myers Squibb • Indianapolis, IN

2d • $124,449 - $150,803 • Onsite

About The Position

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.

Requirements

• 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.

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

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 include: 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 Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager