Manager, QA Engineering

Bristol Myers Squibb; Summit (NJ); On-site; USD 101,000 - 121,000; Full time

Benefits offered by this job

Health Coverage

401(k) Plan

Paid Time Off

Job summary

Bristol Myers Squibb seeks a Manager, QA Engineering to provide quality oversight for Site Technology Transfer activities in a fast-paced manufacturing facility in Summit, NJ. The role includes reviewing validation/qualification documents for equipment and facilities and ensuring data governance and regulatory compliance.

You may lead a team or act as an individual contributor, driving calibration programs, investigations, and CAPA execution while coordinating with cross-functional groups to

Qualifications

• Must have GMP, Quality, and risk management knowledge.
• Experience designing URS, IQ/OQ/PQ, UAT and qualification docs.
• Fluent with MS Office; experience with quality systems software.

Responsibilities

• Support QA Engineering activities for equipment, utilities, and facilities.
• Review GMP documents and calibration/maintenance programs.
• Lead investigations with root-cause analysis and CAPA tracking.

Skills

GMP Knowledge

Quality Systems

Risk Management

Document Review

Cross-functional Collaboration

Education

Bachelor of Science

Tools

Maximo

BMSDocs

Infinity/Valgenesis

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 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.


• Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.


• 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 resolve complex issues with minimal direction from management.


• Work is self-directed.


• Is a recognized Subject Matter Expert within the group.


• 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.


• 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 five years of experience in the pharmaceutical or related industry.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview

Summit West - NJ - US: $100,100 - $121,293

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefits

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental and vision care.


• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).


• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support and survivor support.

Work-life Benefits Include

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))


• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Responsibilities

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1605483 : Manager, QA Engineering