QA Compliance Manager: Change Control & Data Integrity

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

Job summary

RayzeBio in Indianapolis, a Bristol Myers Squibb subsidiary, seeks a Manager, QA Compliance to lead site quality operations including change control, complaints, and data integrity within a cGMP framework.

The role requires a bachelor’s degree in engineering or life/physical sciences, 5+ years in QA, and strong leadership, communication, and knowledge of US/EU cGMP regulations. Cross-functional collaboration is essential.

Qualifications

• Bachelor's degree in engineering or life/physical sciences required.
• Minimum 5 years of work experience in Quality Assurance.
• Knowledge of US/EU cGMP regulations and guidance.
• Demonstrated leadership, interpersonal, communication, and motivation skills.

Responsibilities

• Implements and manages Change Control Quality System for GMP activities and cross-functional coordination.
• Run Change Control Review Boards and document minutes; follow up on actions.
• Communicate with cross-functional stakeholders about the change control process.
• Lead investigations and CAPA review boards timely.
• Site Quality Council lead and develop quality metrics to monitor compliance.

Skills

Leadership

Quality Assurance

Communication

Decision making

Education

Bachelor's degree in engineering or life/physical sciences

Job description

RayzeBio in Indianapolis, a Bristol Myers Squibb subsidiary, seeks a Manager, QA Compliance to lead site quality operations including change control, complaints, and data integrity within a cGMP framework.

The role requires a bachelor’s degree in engineering or life/physical sciences, 5+ years in QA, and strong leadership, communication, and knowledge of US/EU cGMP regulations. Cross-functional collaboration is essential.