Manager, QA Engineering
Bristol Myers Squibb
August 25, 2026
Remote friendly (Summit, NJ)
United States
Operations
Position Summary:
Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) provides quality oversight for Site Technology Transfer activities in a clinical and commercial cell therapy CAR T manufacturing environment. Ensures timely review of validation/qualification documents, technology transfer documents, investigations, and evaluation of change controls (aligned to BMS policies/Global cGMP).
Duties/Responsibilities:
- Support QA Engineering group activities as assigned.
- Support Qualification/Validation for QC and manufacturing equipment, utilities, and facilities.
- Review GMP system documents (procedures, forms, etc.).
- Assure calibration/maintenance programs, validation plans, qualification protocols, reports, and procedures are appropriate.
- Support investigations with thorough impact assessment, RCA, and CAPA documentation/implementation.
- Ensure compliance with site validation master plan; support facility start-up operations/product transfers.
- Ensure data governance/data integrity compliance.
- Work with Engineering/Facilities/ECQ to meet global regulatory requirements.
- Ensure procedures confirm data appropriateness; review/approve equipment/utility/facility deviations/discrepancies.
- (People manager) Coach and develop direct reports; lead cross-functional alignment.
Qualifications/Required Skills:
- B.S. degree required; 5+ years pharma/related industry experience.
- GMP/Quality and in-depth risk management knowledge.
- Experience creating/using user requirement specs; IQ/OQ/PQ protocols; UAT; equipment/utility/facility qualification.
- Microsoft Office proficiency; CMMS (e.g., Maximo) and EDMS/quality systems (e.g., BMSDocs, Infinity/Valgenesis).
- Strong scientific/technical judgment, report/investigation authoring and critical review, CAPA/RCA knowledge, trend/pattern recognition, cross-functional communication, independent problem-solving.
Benefits (explicitly listed):
- Health coverage; wellbeing support; 401(k) and insurance/disability benefits.
- Paid time off (flexible/unlimited for US exempt; 160 hours vacation + holidays for certain locations).
Application instructions:
If the role doesn’t perfectly match your resume, BMS encourages you to apply anyway.
Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) provides quality oversight for Site Technology Transfer activities in a clinical and commercial cell therapy CAR T manufacturing environment. Ensures timely review of validation/qualification documents, technology transfer documents, investigations, and evaluation of change controls (aligned to BMS policies/Global cGMP).
Duties/Responsibilities:
- Support QA Engineering group activities as assigned.
- Support Qualification/Validation for QC and manufacturing equipment, utilities, and facilities.
- Review GMP system documents (procedures, forms, etc.).
- Assure calibration/maintenance programs, validation plans, qualification protocols, reports, and procedures are appropriate.
- Support investigations with thorough impact assessment, RCA, and CAPA documentation/implementation.
- Ensure compliance with site validation master plan; support facility start-up operations/product transfers.
- Ensure data governance/data integrity compliance.
- Work with Engineering/Facilities/ECQ to meet global regulatory requirements.
- Ensure procedures confirm data appropriateness; review/approve equipment/utility/facility deviations/discrepancies.
- (People manager) Coach and develop direct reports; lead cross-functional alignment.
Qualifications/Required Skills:
- B.S. degree required; 5+ years pharma/related industry experience.
- GMP/Quality and in-depth risk management knowledge.
- Experience creating/using user requirement specs; IQ/OQ/PQ protocols; UAT; equipment/utility/facility qualification.
- Microsoft Office proficiency; CMMS (e.g., Maximo) and EDMS/quality systems (e.g., BMSDocs, Infinity/Valgenesis).
- Strong scientific/technical judgment, report/investigation authoring and critical review, CAPA/RCA knowledge, trend/pattern recognition, cross-functional communication, independent problem-solving.
Benefits (explicitly listed):
- Health coverage; wellbeing support; 401(k) and insurance/disability benefits.
- Paid time off (flexible/unlimited for US exempt; 160 hours vacation + holidays for certain locations).
Application instructions:
If the role doesn’t perfectly match your resume, BMS encourages you to apply anyway.