Senior Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities)

Bristol Myers Squibb seeks a Senior Manager to oversee quality assurance for equipment, laboratory methods, utilities, and facilities validation. The role ensures compliance with cGMP standards, manages validation documentation, supports data integrity initiatives, and may involve leading a QA Engineering team.

Responsibilities

• Provide quality oversight for site validation and QC laboratory method/equipment validation activities
• Maintain validation and qualification documents; support data integrity and regulatory compliance
• Ensure calibration/maintenance programs and validation protocols meet global cGMP standards
• Lead QA Engineering team (when in people manager capacity) and ensure timely completion of objectives
• Work with laboratory management to ensure compliance with global regulatory requirements

Requirements

• Bachelor of Science degree
• Minimum 7 years pharmaceutical or related industry experience
• GMP, quality, and risk management expertise
• Experience designing IQ/OQ/PQ protocols and qualification documentation
• Proficiency in Microsoft Office, CMMS (e.g., Maximo), and quality systems software
• Strong technical writing and critical review skills
• Ability to lead cross-functional teams and manage complex initiatives