QA Compliance Leader: Change Control & Quality Programs

Biopharma Careers; Indianapolis (IN); On-site; USD 124,000 - 151,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial well-being

Job summary

RayzeBio in Indianapolis is seeking a QA Compliance Manager to lead GMP quality systems, change control, CAPA, and data integrity initiatives. You will drive cross-functional collaboration, oversee quality metrics, and contribute to inspections and continuous improvement initiatives.

The role emphasizes leadership, strong communication, and rigorous adherence to US/EU cGMP regulations, with opportunities to apply AI to enhance decision-making and team performance.

Qualifications

• Bachelor's degree in engineering or life/physical science (biology, biochemistry, chemistry)
• Minimum 5 years of Quality Assurance experience
• Knowledge of US/EU/rest-of-world cGMP regulations
• Strong leadership and communication skills
• Excellent writing and oral communication skills
• Attention to detail and sound judgment
• Experience with clinical/manufacturing quality operations

Responsibilities

• Implements and Manages the Change Control Quality System for GMP activities with cross-functional alignment
• Run Change Control Review Boards and capture meeting minutes; follow up on actions
• Communicate with cross-functional stakeholders on change control matters
• Manage investigations and CAPA reviews in a timely manner
• Lead the site Quality Council program and serve as Quality Council Lead
• Develop and maintain Quality Metrics to monitor compliance
• Collaborate with stakeholders to resolve quality system issues
• Lead site Data Integrity Program and handle complaints
• Participate in inspections with corporate or health authorities
• Identify discrepancies and escalate to management
• Make sound decisions within defined policies; notify management as needed
• Lead cross-functional teams and drive quality initiatives
• Apply AI to improve team execution and decision-making

Skills

Quality Assurance

Change Control

CAPA

Data Integrity

Leadership

Communication

Decision Making

Quality Metrics

Auditing

Education

Bachelor’s degree (engineering or life/physical science)

Tools

GxP systems

Job description

RayzeBio in Indianapolis is seeking a QA Compliance Manager to lead GMP quality systems, change control, CAPA, and data integrity initiatives. You will drive cross-functional collaboration, oversee quality metrics, and contribute to inspections and continuous improvement initiatives.

The role emphasizes leadership, strong communication, and rigorous adherence to US/EU cGMP regulations, with opportunities to apply AI to enhance decision-making and team performance.