Manager, QA Engineering

Bristol-Myers Squibb; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Bristol Myers Squibb is seeking a Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) to oversee site technology transfer activities in a fast-paced manufacturing facility producing CAR T and drugs.

The role covers review of validation/qualification docs, change controls, and investigations with CAPA. It may be individual contributor or people manager, guiding cross-functional teams and ensuring data integrity per global standards.

Qualifications

• Must have GMP, Quality, and in-depth risk management knowledge.
• Experience in design of user requirement specifications, IQ/OQ/PQ protocols, UAT and other qualification documentation.
• Fluent in standard Microsoft Office; experience with Maximo and quality systems software.

Responsibilities

• Provide QA Engineering support for Site Technology Transfer activities.
• Review validation/qualification documents for equipment, utilities and facilities.
• Review technology transfer documents and investigations with CAPA when needed.
• Ensure data governance and data integrity across site operations.
• Coach and develop direct reports if acting as people manager.

Skills

GMP knowledge

Risk management

IQ/OQ/PQ protocols

Maximo CMMS

Data integrity

Technical writing

Cross-functional collaboration

Quality systems

Tools

BMSDocs EDMS

Infinity/Valgenesis

Microsoft Office

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position Summary

The Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) role is responsible for providing quality oversight for Site Technology Transfer activities in accordance with BMS policies, standards, procedures, and Global cGMP in a fast-paced, highly collaborative clinical and commercial manufacturing facility producing cell therapy CAR T and drug products. Functional responsibilities include ensuring accurate and timely review of validation and qualification documents for all equipment, computerized systems, utility, and facility activities; ensuring accurate and timely review of technology transfer documents; ensuring accurate and timely review of investigations and evaluation of change controls.

Note: This Manager, QA Engineering (Equipment/Lab Methods/ Utilities/Facilities) role may apply to individual contributor or people manager. When fulfilling the people manager role, the Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) is responsible for leading the team, with distinct roles and responsibilities, in maintaining alignment between business process owners, end users, and other cross functional groups/areas.

Duties/Responsibilities

• Able to support activities for the QA Engineering group as assigned.
• Supports the Qualification and Validation activities in relation to QC and manufacturing equipment, utility, and facility design.
• Able to provide adequate review of system GMP documents (operational and maintenance procedures, forms etc.).
• Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports, and procedures.
• Supports ECQ, Facilities, QC, and manufacturing equipment-related investigations in ensuring appropriate and thorough impact assessment, root cause analysis and corrective/preventive actions are documented and implemented.
• Ensures compliance with the site validation master plan, assists with facility start-up operations and product transfers supporting the Qualification and Validation teams.
• Ensures site is compliant with global and regulatory data governance and data integrity requirements.
• Works with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements.
• Ensures procedures are adequate to review and confirm appropriateness of data.
• Reviews/approves of equipment/utility/facility related deviations/ discrepancies.
• People manager should have the ability to coach and develop direct reports.

Qualifications

Specific Knowledge, Skills, Abilities:

• 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 equipment/utility/facility qualification documentation.
• Must be fluent in standard Microsoft Office software; experience in Computer Maintenance Management System (e.g., Maximo) and quality systems software (e.g., BMSDocs Electronic Document Management System, Infinity/Valgenesis).
• Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
• Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
• Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
• Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
• Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job functi