Associate Director, Quality Systems - Indianapolis IN

Company: Msccn
Location: Indianapolis
Posted on: April 1, 2026

Job Description:

Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. 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). Job 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 Additional Qualifications/Responsibilities 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 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 Previous experience in directly dealing with health authority inspectors is preferred but not required Physical Demands 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 travel of up to 10%. Work Environment The noise level in the work environment is usually moderate. LI-Onsite If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Indianapolis - RayzeBio - IN: $164,838 - $199,745

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