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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 Sr. Specialist, Document Control is responsible for managing and maintaining cGMP documentation processes on a non-routine basis, including initiation, issuance processing, routing, distribution, reconciliation, and archiving. This role involves issuing of logbooks, document reviews, archival and creating and maintaining templates for local documents while providing input for global documents. The specialist serves as the primary point of contact for the EDMS across the site and network, offering support for resolving complex issues related to the EDMS and other electronic documentation systems such as electronic batch records and ValGenesis.

Duties/Responsibilities

+ Performs initiation, issuance processing, routing, distribution, reconciliation and archiving of cGMP documentation on a non-routine basis.

+ Issues logbooks as requested from the EDMS.

+ Manages the periodic review program for site documents.

+ Creates and maintains templates for local documents and provides input for global documents.

+ Serves as point of contact for the EDMS across site and network.

+ Provides support for the resolution of complex issues related to the EDMS and other electronic documentation systems (e.g., electronic batch records, ValGenesis).

+ Perfoms gaps analysis to align local procedures with global procedures and policies.

+ Identifies improvement opportunities and drives the execution of site/team continuous improvement goals and projects.

+ Support internal and external inspections as required.

+ May present individual topics during audits as needed.

+ Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.

+ Support integration of newer team members and provide guidance and coaching to users of the EDMS, as required.

+ Lead meetings and represent function at cross functional and network meetings.

+ Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.

+ Act as Document Control SME to assist with completion of Quality Records as required including CAPAs, Deviations, and Change Controls.

Reporting Relationship

This position reports to the Associate Director of Quality Systems and Compliance.

Qualifications

Specific Knowledge, Skills, Abilities:

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

+ Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets, etc.

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

+ Ability to review and process controlled documents in an electronic document management system.

+ Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy.

+ 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.

+ Able to independently work across and influence cross-functional groups and network teams to ensure requirements are met.

+ Ability to motivate and foster a positive team environment.

+ Confident in making decisions, able to anticipate Quality issues and proactively solve problems.

+ Curious and ability to think critically to create innovative solutions.

Education/Experience/ Licenses/Certifications:

+ 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 experience in document control organization/function. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

+ Demonstrated experience with quality management systems.

Experience with EDMS is required.

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 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.

On-site Protocol

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.

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 [email protected] . 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:** R1592020

**Updated:** 2025-06-12 03:59:12.933 UTC

**Location:** Warren-NJ

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.