Document Senior Specialist – Quality Management Systems
Location: Hyderabad, Telangana, India
Company: Bristol Myers Squibb (BMS)
Job Type: Full-Time | Onsite / Site-by-Design
About Bristol Myers Squibb
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader committed to delivering scientific innovation that transforms patients’ lives. The organization offers a dynamic work environment driven by meaningful challenges, groundbreaking research, and opportunities for long-term professional growth. Employees at BMS contribute to impactful work across diverse domains, including manufacturing, quality, cell therapy, and regulatory sciences.
BMS also promotes flexibility through hybrid and site-based work models, along with comprehensive benefits designed to support employees both professionally and personally.
Role Overview
The Document Senior Specialist is responsible for managing and maintaining procedural documents within the Quality Management System (QMS) framework. This role supports documentation governance, ensures compliance with global standards, and provides cross-site expertise on document management processes. The position requires strong understanding of cGMP, quality systems, and regulatory expectations, along with hands-on experience in document lifecycle management.
Key Responsibilities
Quality Documentation and QMS Oversight
Facilitate the creation, review, approval, issuance, implementation, and retirement of site procedural documents.
Conduct compliance assessments of documents against Global Procedures and Policies.
Maintain up-to-date knowledge on industry standards and evolving regulations related to quality systems and document management.
Subject Matter Expertise
Serve as the site SME for procedural documents and QMS requirements.
Provide cross-functional support across multiple document management systems.
Support strategic initiatives and continuous improvement projects related to QMS.
Process Ownership and Collaboration
Work with functional teams to synthesize SME feedback and resolve documentation gaps.
Coordinate with global document management teams as required.
Support audits, inspections, and CAPA-related documentation tasks.
Project and Risk Management
Manage documentation-related project activities, ensuring milestone delivery.
Escalate risks and issues to leadership when necessary.
Collect and analyze documentation metrics to identify trends and implement corrective actions.
Cross-functional Quality Support
Assist in implementation and maintenance of broader QA systems including Change Control, Quality Risk Management, Product Quality Complaints, and Annual Product Quality Reviews.
Required Qualifications and Experience
Education
Bachelor’s degree (minimum requirement) in a scientific, engineering, or related discipline.
Experience
Minimum 3 years of experience in the biopharmaceutical, pharmaceutical, or cell therapy industry.
Cross-functional experience in Quality, Manufacturing, Research, Analytical, Engineering, Regulatory CMC, or IT is preferred.
Proven knowledge of cGMP requirements and global health authority regulations.
Strong competency in procedural document writing, including grammar, technical clarity, and structured organization of information.
Experience in a matrixed organization, demonstrating strong negotiation and influence skills.
Ability to work independently with oversight, while managing timelines and escalating risks appropriately.
Professional fluency in English for reading, writing, and speaking.
Work Environment and Onsite Protocol
BMS classifies roles based on required onsite presence:
Site-Essential: 100% onsite.
Site-by-Design: Hybrid model with at least 50% onsite.
Field-Based / Remote-by-Design: Travel required for customers, studies, or business meetings.
This position follows BMS site occupancy guidelines based on job duties and operational requirements.
Equal Opportunity and Accessibility
BMS is committed to creating an inclusive environment for individuals with disabilities. Reasonable accommodations are available throughout the recruitment process upon request. The company adheres to all Equal Employment Opportunity laws and supports applicants with diverse backgrounds, including those with prior arrest or conviction records where permitted by law.
Important Notes
BMS never requests payments or sensitive financial information during the hiring process.
Applicants should refer to official BMS resources for fraud protection and data privacy practices.
Apply Now
Advance your career by joining one of the world’s leading biopharmaceutical organizations.
Submit your application through thepharmadaily.com and take the next step toward contributing to impactful work in Quality Systems and Documentation.
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