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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 Shop Floor Quality organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at the Devens Cell Therapy Facility in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs).

In the capacity of Shop Floor QA, the Senior Specialist shall serve as one of the Shop Floor Representatives interacting with Quality Control and Laboratories, additionally the individual will be tasked and responsible to handle Shop Floor Quality internal compliance, training and documentation tasks, routine communication to front line employees, and metrics/monitoring for key processes. The incumbent will have responsibility to implement both GMP and business systems/processes with the guidance of the Shop Floor Leadership team, with the goal of enabling the highest standards of patient safety, compliance, and operational efficiencies.

The Senior Specialist, Shop Floor QA, is accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own, review or approve Floor Quality GxP records including but not limited to procedures, CAPAs, change controls, impact assessments, documentation, or deviations; and represents SFQA at relevant governance forums. Additionally, the incumbent shall flex to support deviation approval or batch record review as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed.

This position reports to the Associate Director, Shop Floor Quality Assurance, and is a key member of the Shop Floor Quality leadership team. This is an individual contributor role working Monday to Friday.

Key Responsibilities

• Work in consult with FQA Senior Managers and Managers to proactively identify and implement Quality Management System (QMS), procedures or other communications to improve quality operations.

• Must have the ability to evaluate complex situations/data and make recommendations within the FQA leadership team and cross-functionally.

• Provide Quality on-the-floor oversight to [Manufacturing/QC/Warehouse/ Packout] operations. Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management.

• May perform and document operational verification per approved procedures.

• Develops, reviews and/ or approves temporary and non routine procedure for event response.

• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.

• Provide quality oversight to non routine maintenance work. Review and approve return to service plans.

• Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediation's and drive alignment of implementation plans.

• Own shift actions for departmental programs and propose improvements to programs.

• Participate in Gemba walks.

• Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies independently and escalate as required.

• Author, review, and approve procedural documents.

• Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel.

• May own training curriculum and content.

• May present individual topics during audits as needed.

• Independently assess discrepancies for entry into quality system and approve deviations as applicable.

• May serve as quality subject matter expert for risk assessments, change controls, etc.

• Lead meetings and represent function at cross functional meetings.

• Share data/knowledge within and across team. Build & maintain strong relationships with partner functions.

• May prioritize and assign tasks for the team.

• Periodically observe operations occurring on the floor and proactively identify risks and drive improvements.

• Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.

• Reviews/approves change controls and computer system validation/qualification and provides impact assessments as the FQA representative.

• Work closely with FQA leaders to develop departmental controls and policies to ensure compliance alignment.

• Functions as a project manager able to influence others based on time and task commitments, organize/run meetings, and prioritizing work for colleagues.

• Obtain access to, and develop as an SME for, various electronic systems utilized by Shop Floor Quality (BMSDocs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.).

• Must be familiar with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting.

• Build and maintain strong relationships with functions outside core function and seek collaborative solutions.

• Share data/knowledge within and across teams by acting as a champion for quality-culture and learning.

Qualifications & Experience

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines.

• Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications.

• Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.

• Excellent written and verbal skills and ability to present technical data effectively based on target audience.

• Ability to work in a fast-paced team environment and lead peers through changing priorities.

• Detail oriented and task focused with ability to meet deadlines and support work prioritization.

• Ability to negotiate and influence to craft mutually beneficial solutions.

• Ability to motivate and foster a positive team environment.

• Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.

• Pioneering mindset and ability to create innovative solutions.

• Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.

• Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.

• Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.

• 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

• Demonstrated experience with quality management systems

• Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP)

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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.

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 an inclusive culture, promoting diversity 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.

On-site Protocol

BMS has a diverse 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.

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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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/

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

Company: Bristol-Myers Squibb

Req Number: R1585600

Updated: 2024-09-19 06:20:39.030 UTC

Location: Devens-MA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.