Document Senior Specialist

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 Key Responsibilities This position is responsible for facilitating site procedural documents across areas of the QMS Framework and in association with electronic systems that support maintaining the QMS This includes but not limited to document authoring coordination of review and comments resolution approval issuance implementation periodic review and retirement Responsible for compliance assessment of procedural documents against Global Procedures and Policies Maintain a contemporary knowledge of current industry trends standards and methodologies as it relates to quality systems and document management Serves as the site Subject Matter Expert for procedures and their QMS and provides cross site support for a variety of different document management systems and process Support strategic initiatives and continuous improvement projects related to QMS Synthesize feedback from SMEs procedural document teams to identify and resolve issues in order to accurately document current and future processes May be required to effectively manage projects escalate issues as necessary and identify meet key milestones Work with guidance to manage the development of site procedural documents and seek input as needed May be required to be a representative for global document management initiatives and projects Support site inspections and audits Exercise sound judgment using a risk-based approach to ensure compliance with procedural document regulations practices and policies Collect metrics to identify trends and take appropriate action Responsible for communication of procedural document status to businesses Maybe required to support the implementation and or maintenance of additional QA Systems which may include but is not limited to Documentation Change Control Quality Risk Management Product Quality Complaints and Annual Product Quality Reviews Support the completion of investigation CAPA activities as required Qualification and Experience Education Minimum of a bachelor s degree 3 years experience in the BioPharm Pharmaceutical Cell Therapy industry Cross-functional experience in one or more areas i e research analytical quality engineering manufacturing regulatory CMC or IT is preferred Experience with demonstrated knowledge in quality and or compliance discipline with in-depth knowledge of cGMP requirements and global health authorities regulations Experience Knowledge In depth knowledge of cGMP requirements and global health authority regulations with ability to interpret apply and implement Experience in negotiating and influencing skills in a matrixed organization High level of competency in procedural document writing including the appropriate use of grammar syntax and organization of ideas Demonstrated ability to work independently with oversight from manager Ability to identify manage and or escalate issues and risks to timelines Fluent in English with proven professional working proficiency in English for reading writing and speaking 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 TM 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 Visit 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 Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations