Bristol Myers Squibb
Sr. Manager, Quality Assurance for Quality Control
Bristol Myers Squibb, Indianapolis, Indiana, us, 46262
Sr. Manager, Quality Assurance for Quality Control
Summary
The Senior Manager, QA for QC oversees quality in the Quality Control (QC) Analytical and Microbiology laboratories at RayzeBio Indianapolis, ensuring compliance with RayzeBio policies, SOPs, and cGMP. The role includes sample management, testing, data review, method development, validation, transfer, equipment validation, and related projects. The manager supports QC investigations, change control, SOP approvals, and regulatory audit preparation.
Job Responsibilities
Oversight of QC laboratory operations including investigations, deviations, corrective or preventive actions, method development, validation, transfer, equipment validation, and associated projects.
Support QC activities related to in-process and release product testing, raw material testing, and environmental monitoring.
Assess QC-driven change controls and support completion of associated change actions.
Participate in laboratory operations, continuous improvement, and risk management projects.
Conduct risk assessments related to QC laboratory operations.
Identify and report discrepancies from required work practices or procedures to management.
Make decisions by exercising judgment within defined practices and policies, applying appropriate notification to management.
Participate in audit and inspection response teams for health authorities.
Conduct regular walkthroughs of QC laboratories.
Review and approve Quality, Laboratory, and Analytical SOPs and related documents.
Provide oversight to identify and implement changes that drive long-term department and company goals.
Education and Experience
Bachelor’s degree in engineering or a life or physical science related field (biology, biochemistry, chemistry).
Minimum 10+ years relevant work experience in analytical development, QC, or QA, preferably in a regulated environment. Equivalent combination of education and experience may substitute.
Skills and Qualifications
Knowledge of analytical method lifecycle including development, validation, and transfer.
Practical understanding of common QC procedures, techniques, and laboratory equipment, and application and interpretation of GMP concepts and compendia requirements (US FDA, CFR, USP, EP, JP).
Knowledge of microbiological assay methodologies such as sterility, bioburden, container closure, and endotoxin.
Knowledge of QC and environmental monitoring procedures and techniques.
Strong background in quality assurance operations and compliance of clinical and commercial quality laboratories.
Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
Experience with FDA, EMA, or other regulatory authority.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Excellent writing and oral communication skills.
High attention to detail and sound judgment in decision-making.
Organizational and prioritization skills.
Physical Demands Regularly required to sit, reach with hands and arms, and talk or hear. Occasionally must lift or move up to 30 pounds. Requires close vision and distance vision. Protective clothing, gloves, and safety glasses necessary while working with radioactive materials.
Compensation Overview Indianapolis – RayzeBio – $141,515 – $171,483. Starting pay range of $124,449 – $150,800, plus incentive cash and stock opportunities. Final compensation determines individual experience and demonstrated skills. Benefits include medical, pharmacy, dental, vision care, well‑being programs, financial protection, and work‑life programs such as paid holidays, vacation, and volunteer days.
Supporting People With Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process and reasonable workplace accommodations. Applicants can request accommodations before accepting a job offer. Contact adastaffingsupport@bms.com for support.
Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws.
Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Referrals increase your chances of interviewing at Bristol Myers Squibb by 2x. If you are interested in this role, please apply.
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Job Responsibilities
Oversight of QC laboratory operations including investigations, deviations, corrective or preventive actions, method development, validation, transfer, equipment validation, and associated projects.
Support QC activities related to in-process and release product testing, raw material testing, and environmental monitoring.
Assess QC-driven change controls and support completion of associated change actions.
Participate in laboratory operations, continuous improvement, and risk management projects.
Conduct risk assessments related to QC laboratory operations.
Identify and report discrepancies from required work practices or procedures to management.
Make decisions by exercising judgment within defined practices and policies, applying appropriate notification to management.
Participate in audit and inspection response teams for health authorities.
Conduct regular walkthroughs of QC laboratories.
Review and approve Quality, Laboratory, and Analytical SOPs and related documents.
Provide oversight to identify and implement changes that drive long-term department and company goals.
Education and Experience
Bachelor’s degree in engineering or a life or physical science related field (biology, biochemistry, chemistry).
Minimum 10+ years relevant work experience in analytical development, QC, or QA, preferably in a regulated environment. Equivalent combination of education and experience may substitute.
Skills and Qualifications
Knowledge of analytical method lifecycle including development, validation, and transfer.
Practical understanding of common QC procedures, techniques, and laboratory equipment, and application and interpretation of GMP concepts and compendia requirements (US FDA, CFR, USP, EP, JP).
Knowledge of microbiological assay methodologies such as sterility, bioburden, container closure, and endotoxin.
Knowledge of QC and environmental monitoring procedures and techniques.
Strong background in quality assurance operations and compliance of clinical and commercial quality laboratories.
Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
Experience with FDA, EMA, or other regulatory authority.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Excellent writing and oral communication skills.
High attention to detail and sound judgment in decision-making.
Organizational and prioritization skills.
Physical Demands Regularly required to sit, reach with hands and arms, and talk or hear. Occasionally must lift or move up to 30 pounds. Requires close vision and distance vision. Protective clothing, gloves, and safety glasses necessary while working with radioactive materials.
Compensation Overview Indianapolis – RayzeBio – $141,515 – $171,483. Starting pay range of $124,449 – $150,800, plus incentive cash and stock opportunities. Final compensation determines individual experience and demonstrated skills. Benefits include medical, pharmacy, dental, vision care, well‑being programs, financial protection, and work‑life programs such as paid holidays, vacation, and volunteer days.
Supporting People With Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process and reasonable workplace accommodations. Applicants can request accommodations before accepting a job offer. Contact adastaffingsupport@bms.com for support.
Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws.
Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Referrals increase your chances of interviewing at Bristol Myers Squibb by 2x. If you are interested in this role, please apply.
#J-18808-Ljbffr