Document Manager

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 . - 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, retirement and archival. - Responsible for compliance assessment of procedural documents against Global Procedures and Policies and evolving global health authority regulations and health authority inspection observations. Write and revise document control procedures including leading the development and roll-out of document control tools. - 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. - Identifies and supports 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 - Effectively manage projects, escalate issues as necessary and identify/meet key milestones - Work with limited guidance to manage the development of site procedural documents and, seek input as needed - 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 - May be required to support updates to existing Quality Systems and implementation of additional Quality Systems. - Act as Document Control SME and owns completion of Quality Records including CAPAs, Deviations, Change Controls, etc. - 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. Qualifications & Experience Education - Minimum of a bachelor's degree - 5+ years experience in the BioPharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT) - Experience with demonstrated knowledge in quality and/or compliance discipline with in-depth knowledge of cGMP requirements and global health authorities regulations - In depth knowledge of cGMP requirements and global health authority regulations with ability to interpret, apply and implement. - Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheet, etc. - Proficiency in reviewing and processing controlled documents in an electronic document management system. - Excellent verbal and technical writing skills with advanced ability to independently prepare written communications 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. - Confident in making decisions, able to anticipate Quality issues and proactively solve problems. - Curious and ability to think critically to create innovative solutions. - Lead Document Control Projects as needed for continuous improvement and site wide implementations. - Strong negotiating and influencing skills in a matrixed organization. - Demonstrated ability to work independently and mentor team members. - 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 , 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 [Confidential Information] . Visit careers.bms.com/ 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.