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The QMS Document Manager at the S-12 Cell Therapy Manufacturing is responsible for the documentation in the all-lifecycle management found in the electronic documentation system and reports directly to the S-12 Document Administration Manager. The individual will be responsible for overall support, document, and process management related to the document lifecycle. This is a hands-on role that will involve close collaboration and active support department in document simplification strategies with the provision for on-time workflow process quality for documents stored in the electronic documentation system.

The Document Administration organization is responsible for the establishment, maintenance, and continuous improvement of the Document Administration system process, procedures, and responsibilities for achieving quality policies and objectives. This organization supports the S-12 facility to ensure patient safety, and regulatory requirements and improve its effectiveness and efficiency continuously.

DUTIES AND RESPONSIBILITIES:

• Create timelines for document review/approval process activities and submits to the project lead.

• Contribute to and support the development, implementation, and optimization of various tracking tools, e.g., Veeva Vault, and SharePoint track

• Collect metrics to identify trends and take appropriate action.

• Assist in the preparation of departmental standard operating procedures.

• Collaborate with business users and the internal Quality compliance team to ensure best practices are used to support procedure document updates (i.e., Standard Operation Procedures, Work Practices, etc.) as required.

• Authors and/or reviews documents with minimum supervision.

• Performs and/or analyzes document content and advise ways to maximize clarity of documentation.

• Communicates results to cross-functional teams, provides recommendations simplification interpretation in documents such as SOPs, WP, TRN, etc.

• Compliant with BMS processes and SOPs, adherence to global/local standards and responsible for quality of deliverable.

• Communicates effectively with management, quality unit, peers and colleagues within and outside the department for all documentation related issues.

• Participates in selected initiatives leading to the improvements on cGMP documentation.

• Schedule, prepare for, and lead kick off meetings for document simplification in collaboration with subject matter experts/project leads including scope and rationale, timelines, and document contributors.

• Responsible for the quality of output documents and ensures content meets appropriate editorial standards (style, formatting, document requirements, etc.) to ensure high quality deliverables.

• Ensure the coordination and execution of timely and efficient internal review and approvals.

• Process of Document Change Notices for new/revised/obsolete documentation.

• Effectively manage large volumes of documents.

• Effectively prioritize tasks and projects, to meet timelines.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

• Ability to independently manage multiple projects with accountability and excellent work ethic

• High Level of compliance writing competency, specifically in the appropriate use of grammar

• Provide close attention to detail through proofing and quality assurance

• Proven skills in collaboration with cross-functional teams and in a team environment

• Excellent and effective verbal and written communication skills with the ability to interface with the Management Leadership team, and interdisciplinary project teams.

• Acute attention to detail

• Gradual ability to analyze the scope of documents and in turn recommend strategies to document owner functional area manager.

• Highly strategic and proactively recognizes problems and foresees opportunities with a tendency to act with a solutions-driven attitude.

Education and Experience:

• BS Degree

• Minimum of 5 years of document review experience

• Experience working in Pharma, GMP

• Experience using documentation systems

• Equivalent combination of education and experience acceptable

Preferred Experience

• Minimum of 7 years of document review experience with Pharm

• Experience using Veeva Vault

WORKING CONDITIONS (US Only):

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 30% of the time. Lighting and temperature are adequate, and no abnormal conditions are caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions essential to this job’s performance.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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