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

Regulatory Toolkit; Madison (NJ); On-site; USD 122,000 - 148,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

Stock opportunities and discretionary

Job summary

Bristol Myers Squibb is seeking a Senior Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) in Madison, NJ. You will oversee site validation activities and QC lab method/equipment qualification, ensuring regulatory compliance and data integrity across projects.

Reporting to the Associate Director, QA Operations, you will lead the QA Engineering team, drive continuous improvement, and partner cross-functionally to align business processes with quality 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 qualification documentation.
• Fluent in standard Microsoft Office software; experience with Maximo and quality systems software.

Responsibilities

• Supports all activities for the QA Engineering group.
• Supports Qualification and Validation activities for QC/manufacturing equipment, utility, and facility design.
• Ensures calibration/maintenance programs, validation plans, qualification protocols, reports, and procedures are appropriate.
• Ensures site compliance with global regulatory data governance and data integrity requirements.
• Maintains procedures to ensure Data Integrity and compliance.
• Works with lab management to ensure activities comply with global regulatory requirements.
• Ensures site stability program meets global and regulatory requirements.
• Ensures method qualifications, method transfers, and analyst trainings meet requirements.
• Manages QA Engineering team to meet objectives.

Skills

GMP knowledge

Risk management

IQ/OQ/PQ protocols

Data integrity

Written reports

Decision making

Communications

Problem solving

Education

Bachelor of Science

7+ years pharmaceutical experience

Tools

Maximo

BMSDocs Electronic Document Management System

Infinity/Valgenesis

Job description

Position Summary

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The Senior Manager is responsible for providing quality oversight for Site Validation activities and Quality Control Laboratory method and equipment validation in accordance with BMS policies, standards, procedures, and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of validation and qualification documents for all equipment and facility activities, support data integrity initiatives for the site.

Note: This Senior Manager, QA Engineering (Equipment/Lab Methods/ Utilities/Facilities) role may apply to individual contributor or people manager. When fulfilling the people manager role, the Senior 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

• Supports all activities for the QA Engineering group.
• Supports the Qualification and Validation activities in relation to QC and manufacturing equipment, utility, and facility design.
• Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports, and procedures.
• 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.
• Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.
• Works with laboratory management to ensure laboratory activities comply with global regulatory requirements.
• Ensures the site stability program meets global and regulatory requirements.
• Ensures method qualifications, method transfers, and analyst trainings meet company and regulatory requirements.
• Manage QA Engineering team and assures job objectives are met on a timely basis.

Reporting Relationship

This position will report to Associate Director, QA Operations - Quality Engineering.

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 function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
• Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions.
• Recognizes risk and develops contingency plans.
• Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
• Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Must routinely recognize and resolve Quality issues; propose solutions; develop procedures.
• Must be able to interpret complex results and situations with independence and articulate recommendations for solutions. Recognizes risks and develop contingency plans. Negotiates solutions cross-functionally.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Drives continuous improvement and increases efficiency and productivity.
• Understands fundamental scientific problems.
• Understanding of CAPA’s and root cause analysis (RCA).
• Able to write and review reports with clarity and brevity.

Education/Experience/ Licenses/Certifications:

• Bachelor of Science degree required.
• Minimum of seven years of experience in the pharmaceutical or related industry.

Compensation Overview

Madison - Giralda - NJ - US: $122,150 - $148,011

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.