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): Provide quality oversight for Site Technology Transfer activities in accordance with BMS policies/standards, procedures, and Global cGMP in a clinical/commercial cell therapy (CAR T) manufacturing facility.
Duties/Responsibilities
- Review validation/qualification documents for equipment, computerized systems, utilities, and facilities; review technology transfer documents.
- Review investigations and change controls; ensure thorough impact assessment, root cause analysis, and CAPA are documented and implemented.
- Assure calibration/maintenance programs, validation plans, qualification protocols, associated reports, and procedures are appropriate.
- Support Qualification/Validation activities for QC and manufacturing equipment/utility/facility design; support site startup and product transfers.
- Ensure site compliance with data governance and data integrity; coordinate with Engineering/Facilities/ECQ to meet global regulatory requirements.
- Ensure procedures adequately review and confirm data; review/approve equipment/utility/facility deviations/discrepancies.
Qualifications (Required/Preferred)
- GMP, Quality, and in-depth risk management knowledge.
- Experience designing URS, IQ/OQ/PQ, UAT, and qualification documentation.
- Advanced Microsoft Office; experience with Maximo and/or electronic quality/document systems (e.g., BMSDocs, Infinity/Valgenesis).
- Strong authorship, critical report/investigation review, CAPA/RCA understanding, pattern/trend recognition, and cross-functional communication.
- Bachelor of Science required; minimum 5 years in pharmaceutical/related industry.
Benefits (explicitly stated)
Health coverage (medical/pharmacy/dental/vision); 401(k), disability/life insurance; Paid Time Off.
Application Instruction
If you don’t perfectly match your resume, you’re encouraged to apply anyway.
Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities): Provide quality oversight for Site Technology Transfer activities in accordance with BMS policies/standards, procedures, and Global cGMP in a clinical/commercial cell therapy (CAR T) manufacturing facility.
Duties/Responsibilities
- Review validation/qualification documents for equipment, computerized systems, utilities, and facilities; review technology transfer documents.
- Review investigations and change controls; ensure thorough impact assessment, root cause analysis, and CAPA are documented and implemented.
- Assure calibration/maintenance programs, validation plans, qualification protocols, associated reports, and procedures are appropriate.
- Support Qualification/Validation activities for QC and manufacturing equipment/utility/facility design; support site startup and product transfers.
- Ensure site compliance with data governance and data integrity; coordinate with Engineering/Facilities/ECQ to meet global regulatory requirements.
- Ensure procedures adequately review and confirm data; review/approve equipment/utility/facility deviations/discrepancies.
Qualifications (Required/Preferred)
- GMP, Quality, and in-depth risk management knowledge.
- Experience designing URS, IQ/OQ/PQ, UAT, and qualification documentation.
- Advanced Microsoft Office; experience with Maximo and/or electronic quality/document systems (e.g., BMSDocs, Infinity/Valgenesis).
- Strong authorship, critical report/investigation review, CAPA/RCA understanding, pattern/trend recognition, and cross-functional communication.
- Bachelor of Science required; minimum 5 years in pharmaceutical/related industry.
Benefits (explicitly stated)
Health coverage (medical/pharmacy/dental/vision); 401(k), disability/life insurance; Paid Time Off.
Application Instruction
If you don’t perfectly match your resume, you’re encouraged to apply anyway.