Job Title: Document Senior Specialist
Location: Hyderabad, Telangana, India
Category: Quality Assurance / Quality Systems
Industry: Biopharmaceuticals / Pharmaceuticals / Cell Therapy
Bristol Myers Squibb (BMS) is seeking a highly skilled Document Senior Specialist to support and strengthen site-level Quality Management System (QMS) documentation. This role is critical to ensuring procedural excellence, regulatory compliance, and continuous improvement across quality systems. The ideal candidate will bring strong expertise in document management, cGMP compliance, and cross-functional collaboration within a regulated life sciences environment.
This position offers the opportunity to contribute to life-changing therapies while building a long-term career with a globally respected biopharmaceutical organization.
Manage the full lifecycle of site procedural documents within the QMS framework, including authoring, review coordination, approval, issuance, implementation, periodic review, and retirement
Ensure procedural documents comply with global BMS procedures, policies, and applicable regulatory requirements
Act as the site Subject Matter Expert (SME) for QMS documentation and provide cross-site support for document management systems and processes
Maintain up-to-date knowledge of industry standards, regulatory expectations, and best practices in quality systems and document management
Support strategic initiatives and continuous improvement projects related to QMS effectiveness and compliance
Collaborate with SMEs and document owners to accurately capture current and future state processes
Manage documentation-related projects, track milestones, identify risks, and escalate issues as required
Support global document management initiatives and represent the site in enterprise-level projects when needed
Assist with site inspections, internal audits, and health authority audits
Apply a risk-based approach to ensure compliance with procedural documentation requirements
Track and analyze documentation metrics to identify trends and drive corrective actions
Communicate document status, updates, and compliance metrics to business stakeholders
Support additional QA systems as required, including Change Control, Quality Risk Management, CAPA, Product Quality Complaints, and Annual Product Quality Reviews
Contribute to investigation and CAPA activities related to documentation and quality systems
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related discipline (mandatory)
Experience:
Minimum 3+ years of experience in the biopharmaceutical, pharmaceutical, biotechnology, or cell therapy industry
Demonstrated hands-on experience in quality systems, documentation management, or compliance functions
Cross-functional exposure in areas such as Quality, Manufacturing, Engineering, Regulatory CMC, Research, Analytical Sciences, or IT is preferred
In-depth knowledge of cGMP requirements and global health authority regulations, with the ability to interpret and apply them effectively
Strong expertise in procedural document writing, including grammar, structure, and technical clarity
Experience working within electronic document management systems (EDMS)
Proven ability to work independently with minimal supervision in a matrixed environment
Strong organizational, negotiation, and stakeholder-influencing skills
Ability to identify, manage, and escalate risks impacting timelines or compliance
Excellent analytical and problem-solving capabilities
Professional fluency in English, with strong written and verbal communication skills
This role follows BMS’s site-based or site-by-design occupancy model. Onsite presence is considered essential to collaboration, compliance, and operational effectiveness. Hybrid eligibility may apply based on business requirements and role responsibilities.
At BMS, employees are united by a shared purpose: transforming patients’ lives through science. The organization fosters a culture of inclusion, integrity, innovation, accountability, and continuous learning. Employees benefit from competitive compensation, career development opportunities, and comprehensive benefits designed to support both professional growth and personal well-being.
Bristol Myers Squibb is an Equal Opportunity Employer and is committed to inclusive hiring practices. All qualified applicants will be considered without regard to race, color, religion, gender, sexual orientation, gender identity, age, disability, veteran status, or any other protected characteristic.
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