Manager, QA Engineering

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).