QA Compliance Lead: Change Control & Data Integrity

Bristol Myers Squibb; Indianapolis (IN); On-site; USD 124,449 - 150,803; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) Plan

Disability Insurance

Life Insurance

Travel Protection

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Quality Assurance professional to lead change control and QA operations at the Indianapolis site. You will ensure compliance with cGMP, manage investigations and CAPA boards, and drive metrics across cross-functional teams.

The role requires strong leadership, communication, and detailed judgment to support clinical and manufacturing quality programs in a dynamic biotech environment.

Qualifications

• Bachelor's degree in engineering or life/physical sciences required.
• Minimum 5 years in Quality Assurance.
• Experience with clinical/manufacturing QA compliance.
• Knowledge of US/EU cGMP regulations.
• Strong writing and communication skills.
• Detail-oriented with good judgment.

Responsibilities

• Establishes and manages the Change Control Quality System for GMP activities.
• Runs Change Control Review Boards and tracks action items.
• Communicates with cross-functional stakeholders on change control.
• Manages investigations and CAPA review boards in a timely manner.
• Leads site Quality Council program.
• Develops Quality Metrics to monitor compliance.
• Leads site Data Integrity Program.

Skills

Quality Assurance

Change Control

Leadership

Communication

Attention to detail

Education

Bachelor's degree in engineering or life sciences

Tools

GMP Documentation Systems

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Quality Assurance professional to lead change control and QA operations at the Indianapolis site. You will ensure compliance with cGMP, manage investigations and CAPA boards, and drive metrics across cross-functional teams.

The role requires strong leadership, communication, and detailed judgment to support clinical and manufacturing quality programs in a dynamic biotech environment.