Associate Director, Quality Systems

Bristol Myers Squibb • Indianapolis, IN

3d • Onsite

About The Position

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ Summary The Associate Director, Quality Systems is responsible for operational oversight and maintenance of the Indianapolis site Quality Management System for RayzeBio. This includes establishment, continuous improvement, and ensuring the consistent implementation of global quality system policies in the GMP spectrum. This position will report to the Director, RayzeBio Quality Systems & Compliance and oversee GMP quality systems at RayzeBio Indianapolis site. The position may require Quality oversight of one or more enterprise quality systems (e.g., training, document retention).

Requirements

• At minimum, a bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required.
• Minimum 7-10 years in GxP (GMP, GLP, GCP) pharmaceutical or other regulated environment demonstrating progressive increase in responsibility.
• Highly desirable to have a minimum of 5 years of Quality Systems experience.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience in hosting/facilitating FDA, EMA, or other regulatory authority inspections.
• Ability to successfully solve challenging issues, critical thinking, and detail oriented
• Strong interpersonal, verbal, and written communication skills
• Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.
• Excellent written and verbal communication skills.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.
• Previous experience implementing and developing quality systems is required

Nice To Haves

• Previous experience in directly dealing with health authority inspectors is preferred but not required

Responsibilities

• Leads/supports implementation of GxP Quality Systems at RayzeBio Indianapolis site; including implementation of electronic systems as needed.
• Leads/supports oversight of Quality Assurance Systems including Deviations and Investigations; Corrective and Preventive Actions; Product Complaints; Change Control; Document Control; Document Retention, and GxP Training
• Ensure that the Indianapolis site is always ready for audits and health authority inspections.
• Ability to host the audit/inspection (front and/or back room).
• Actively contribute, as required, to all audits/inspections.
• Ensure creation and implementation of the following at the Indianapolis site Self-inspection program/process GMP regulatory surveillance at the Indianapolis site Health authority communication (GMP only) such as field alerts, APQR, etc.
• Evaluate, author, and/or review operating procedures (e.g. policies, SOPs, etc.), and perform other activities in support of an integrated cross-functional quality management system (QMS).
• Assist in developing quality/KPI metrics/reports to support GxP activities, Quality council meetings, and/or management review.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Provides oversight to identify and implement changes that lead to realization of long-term department and company goals.
• Regularly communicates ongoing/upcoming electronic QMS activities to broader RayzeBio (e.g., via monthly newsletter).
• Supervise up to six direct reports
• Other QA specific responsibilities as assigned by QA management

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: Mid Level
• Number of Employees: 5,001-10,000 employees