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: careers.bms.com/working-with-us .

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™ , 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 adastaffingsupport@bms.com . 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/

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