Senior Document Control Specialist

Job Purpose

The Senior Document Control Specialist is responsible for managing GxP-controlled documentation supporting Manufacturing and Quality Control (QC) operations using the Veeva Quality Suite. This role ensures documents are accurate, current, compliant, and inspection-ready, supporting Ocugen’s evolving manufacturing and regulatory needs.

This is a hands-on role requiring strong document control expertise, experience in regulated environments, and the ability to partner effectively with cross-functional teams

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

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

Working Conditions

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Physical Requirements

This is a mostly sedentary role.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.