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

401(k)

Stock options

Job summary

RayzeBio, an integrated biotech subsidiary of Bristol Myers Squibb, seeks a Manager, QA Compliance in Indianapolis. Lead Change Control processes, CAPA reviews, and the Quality Council, while ensuring adherence to cGMP standards across the site.

Strong leadership and cross-functional collaboration are essential. This role oversees investigations, data integrity, and regulatory compliance, with a focus on quality metrics and inspections readiness.

Qualifications

• Bachelor's degree in engineering or life/physical science is required.
• Minimum 5 years in Quality Assurance.
• Knowledge of US/EU cGMP regulations and guidance.

Responsibilities

• Manage the Change Control Quality System for GMP activities across sites.
• Lead Change Control Review Boards; document minutes and actions.
• Oversight of Quality Council and data integrity program; drive quality metrics.

Skills

Quality Assurance

Regulatory compliance

Leadership

Communication

Education

Bachelor's degree in engineering or life/physical science

Job description

RayzeBio, an integrated biotech subsidiary of Bristol Myers Squibb, seeks a Manager, QA Compliance in Indianapolis. Lead Change Control processes, CAPA reviews, and the Quality Council, while ensuring adherence to cGMP standards across the site.

Strong leadership and cross-functional collaboration are essential. This role oversees investigations, data integrity, and regulatory compliance, with a focus on quality metrics and inspections readiness.