QA Engineering Lead — Validation & Lab Equipment

Bristol Myers Squibb; Madison (NJ); On-site; USD 122,000 - 148,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Global Shutdown

Comprehensive benefits

Job summary

Bristol Myers Squibb seeks a Senior Manager, QA Engineering to oversee site validation activities and QC laboratory method validation in line with global cGMP. The role ensures data integrity, maintains qualification protocols, and aligns with cross-functional teams to support equipment, utilities, and facility projects.

This leadership position may be individual contributor or people manager, directing a team to meet regulatory and site objectives while advancing quality improvements and

Qualifications

• Must have GMP, Quality, and in-depth risk management knowledge.
• Experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other qualification documentation.
• Must be fluent in standard Microsoft Office software; experience in Maximo and quality systems software.
• Must recognize and group technical attributes and drive science-based decisions.
• Must manage development of technical initiatives by interdisciplinary teams.
• Must author and review investigations, interpret results, and generate technical conclusions.
• Must identify patterns and communicate solutions cross-functionally.
• Requires independent task completion and resource coordination with minimum direction.

Responsibilities

• Supports all activities for the QA Engineering group.
• Supports qualification and validation for QC/manufacturing equipment, utilities, and facilities.
• Ensures calibration/maintenance programs, validation plans, and related reports are appropriate.
• Ensures site compliance with global data governance and data integrity requirements.
• Leads data integrity procedures and ensures cross-functional alignment with regulatory standards.
• Oversees site stability program to meet global regulatory requirements.
• Manages QA Engineering team objectives and timelines.

Skills

GMP knowledge

Quality risk management

IQ/OQ/PQ protocols

Data integrity

Cross-functional leadership

Technical reporting

Microsoft Office

Education

Bachelor of Science degree

Tools

Maximo

BMSDocs

Infinity/Valgenesis

Job description

Bristol Myers Squibb seeks a Senior Manager, QA Engineering to oversee site validation activities and QC laboratory method validation in line with global cGMP. The role ensures data integrity, maintains qualification protocols, and aligns with cross-functional teams to support equipment, utilities, and facility projects.

This leadership position may be individual contributor or people manager, directing a team to meet regulatory and site objectives while advancing quality improvements and