Manager, Quality Engineering, Change Control/Document Review

Bristol-Myers Squibb Co; Madison (NJ); On-site; USD 117,000 - 141,000; Full time

Benefits offered by this job

Wellbeing support

Retirement plan

Insurance (medical, dental, vision)

Job summary

Bristol Myers Squibb Co is seeking a Manager, Quality Engineering, Change Control/Document Review for the Summit Cell Therapy Manufacturing facility. You will oversee Change Control, review documents for regulatory compliance, and drive process improvements with cross-functional teams to ensure timely completion.

The role requires cGMP experience, extensive change control writing, and strong data analysis. You will support inspections and contribute to quality system improvements in a fast-paced

Qualifications

• Must have experience with cGMP manufacturing, Quality, and Compliance.
• Strong authorship and ability to evaluate change controls with quality risk principles.
• Must be able to routinely recognize quality issues and interpret problems, as well as proposed solutions for complex issues.
• Must understand continuous improvement and be able to improve the compliance and efficiency of the quality system.
• Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
• Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.
• Requires moderate direction to complete more complex tasks.
• Comfortable providing input/guidance to others within the department and across the organization in change control technical writing.
• Propose solutions for issues and work with management to resolve.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to support internal and health authority inspections of facility.
• Understanding of Change Controls and why they are required.
• Able to write and review reports with clarity and brevity.

Responsibilities

• Manages the change control quality process for all GMP activities and works with responsible cross functional areas ensure timely completion.
• Review and approve change controls and associated documents for appropriateness and to ensure records are in compliance with regulatory requirements and internal procedures.
• Drive or support process improvement initiatives.
• SME support during internal and health authority inspections of facility
• Communicates effectively with cross functional stakeholders on matters related to change control process.
• 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.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.
• Seeks management guidance on complex issues; develops procedures.
• Ability to fully interpret complex results and situations and articulate recommendations for resolution.

Skills

Quality mindset

Authorship

Data analysis

Communication

Problem solving

Decision making

Cross-functional collaboration

Change control writing

Self-directed

Education

Bachelor degree

College degree

Job description

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.

Position Summary

The Manager, Quality Engineering, Change Control/Document Review at the Summit Cell Therapy Manufacturing facility is responsible for supporting the business process owner for Change Control module and the associated governing local procedures and supporting processes. This is a highly visible role with site responsibility and cross-functional influence that has impact on departmental performance and broad quality change control management. The incumbent will serve as the subject matter expert for the Change Control process across the site.

Duties/Responsibilities

• Manages the change control quality process for all GMP activities and works with responsible cross functional areas ensure timely completion.
• Review and approve change controls and associated documents for appropriateness and to ensure records are in compliance with regulatory requirements and internal procedures.
• Drive or support process improvement initiatives.
• SME support during internal and health authority inspections of facility
• Communicates effectively with cross functional stakeholders on matters related to change control process.
• 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.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.
• Seeks management guidance on complex issues; develops procedures.
• Ability to fully interpret complex results and situations and articulate recommendations for resolution.

Qualifications

• Must have experience with cGMP manufacturing, Quality, and Compliance.
• Must have strong authorship and be able to critically evaluate change controls and generate technical conclusions consistent with Quality risk management principles
• Must be able to routinely recognize quality issues and interpret problems, as well as proposed solutions for complex issues.
• Must understand continuous improvement and be able improve the compliance and efficiency of the quality system.
• Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
• Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.
• Requires moderate direction to complete more complex tasks.
• Comfortable providing input/guidance to others within the department and across the organization in change control technical writing.
• Propose solutions for issues and work with management to resolve.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to support internal and health authority inspections of facility.
• Understanding of Change Controls and why they are required.
• Able to write and review reports with clarity and brevity.
• Bachelor of Science degree required.
• Minimum of eight years of experience in the pharmaceutical or related industry.
• College or university degree required.
• An equivalent combination of education and experience may be substituted.

Compensation Overview

Madison - Giralda - NJ - US: $116,660 - $141,368 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 workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in 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] 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.

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.