Ocugen · 5 days ago
Senior Document Control Specialist
Malvern, PA
Full-time
Onsite
Senior LevelOcugen is a biotechnology company focused on developing transformative gene therapies. The Senior Document Control Specialist is responsible for managing GxP-controlled documentation to support Manufacturing and Quality Control operations, ensuring that documents are accurate, compliant, and inspection-ready.
BiopharmaBiotechnologyHealth Care
Responsibilities
Execute the end-to-end lifecycle of controlled GxP documents in Veeva Quality Docs, including SOPs, work instructions, forms, protocols, and records
Serve as a Veeva Quality Docs (VQD) subject matter expert, providing guidance on system usage, hands-on system support and supporting approved configuration changes in alignment with validation and GxP requirements
Ensure documents are initiated, reviewed, approved, issued, maintained, and archived in accordance with internal quality systems and regulatory requirements
Serve as a hands-on partner to Manufacturing and QC teams by maintaining accurate, current, and accessible documentation that supports daily operations
Provide backup support for Quality business capability owners, including Training, QMS administration, and system administration
Coordinate document updates driven by change controls, deviations, CAPAs, audits, and regulatory requirements
Maintain inspection and audit readiness, including document completeness, version control, traceability, and data integrity
Collaborate with QA, QC, Manufacturing, and Regulatory to support compliant execution and continuous improvement
Track and report basic document metrics to provide visibility into document status, throughput, and risks
Support migration, scanning, indexing, and maintenance of electronic records within Veeva as needed
Contribute to the evolution of document control practices and standards as Ocugen’s manufacturing and quality systems scale
Qualification
Required
Bachelor's degree in a scientific, technical, or related field
Strong hands-on experience with Veeva Quality Docs
Solid understanding of GxP documentation requirements and document control best practices
Experience supporting Manufacturing and/or QC documentation in a regulated environment
Ability to manage document lifecycle activities independently and with attention to detail
Preferred
Experience supporting regulatory inspections (e.g., FDA)
Familiarity with Veeva Training or Veeva eQMS
Experience in biotech or pharmaceutical manufacturing environment
Company
Ocugen
Ocugen is a biotechnology company that develops novel gene and cell therapies to improve health and patient outcomes.
Founded in 2013
51-200 employees
H1B Sponsorship
Ocugen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$291.5MKey Investors
Janus Henderson InvestorsAvenue Capital Group
2025-08-08Post Ipo Equity· $20M
2024-11-07Post Ipo Debt· $30M
2024-07-31Post Ipo Equity· $35M
Leadership Team
Shankar Musunuri
Chairman & Co-Founder
Arun Upadhyay
Chief Scientific Officer
Recent News
2026-01-11
Company data provided by crunchbase