CMC QA Lead — Associate Director (Indianapolis)

Bms; Indianapolis, Northern (IN, KY); Hybrid; USD 165,000 - 200,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Flexible time off

Job summary

RayzeBio, a Bristol Myers Squibb company, is seeking an Associate Director of CMC - Quality Assurance to lead QA strategies for manufacturing and analytical activities at our Indianapolis site and related facilities. The role emphasizes collaboration across CMC teams, regulatory interfaces, and rigorous QA stewardship.

The ideal candidate has 10+ years in biologics/sterile QA within development/operations, deep cGMP knowledge, and a track record of implementing QA programs across IND, IMPD, and

Qualifications

• Minimum of a B.S. degree in Chemistry, Biochemistry, or a similar scientific field.
• Ten plus years of hands-on biologics/sterile QA experience in development/operations (manufacturing and/or analytical).
• Prior QA experience and knowledge of cGMPs and regulatory requirements (FDA, EU, ICH).
• Experience leading QA processes: deviations, investigations, CAPAs, and quality systems.
• Experience with radiopharmaceuticals or related modalities is preferred.

Responsibilities

• Member of CMC Development Teams providing QA input from pre-clinical to end of product life cycle.
• Quality oversight for changes through product lifecycle including CAPAs and investigations.
• Review and approve analytical method lifecycle documents and protocols/reports.
• Collaborate with Regulatory to track QA input for regulatory filings and updates (IND/IMPD/NDA).
• Lead change control management and risk assessments as required.

Skills

QA leadership

cGMP knowledge

Radiopharmaceuticals

Analytical method lifecycle

Regulatory strategy

Education

B.S. in Chemistry/Biochemistry or related field

Job description

RayzeBio, a Bristol Myers Squibb company, is seeking an Associate Director of CMC - Quality Assurance to lead QA strategies for manufacturing and analytical activities at our Indianapolis site and related facilities. The role emphasizes collaboration across CMC teams, regulatory interfaces, and rigorous QA stewardship.

The ideal candidate has 10+ years in biologics/sterile QA within development/operations, deep cGMP knowledge, and a track record of implementing QA programs across IND, IMPD, and