Document Control Lead

• The Document Control Lead will serve as a key quality function responsible for establishing, maintaining, and managing the document control systems critical to ensuring regulatory compliance, data integrity, and operational readiness for a greenfield sterile injectable IV bag manufacturing facility.
• This role will drive the creation, organization, distribution, and maintenance of all controlled documentation required to support GMP operations, regulatory submissions, and inspection readiness.
• The incumbent will play a vital role in building document management systems during site startup and ensure robust control throughout the facility lifecycle.
• This role will also be the site technical resource for coordination and qualification of corporate quality electronic document systems including Trackwise, Learning Management System, and the Document Control System.

• Develop and implement comprehensive document control systems aligned with FDA cGMP, ICH, ISO, and company quality standards.
• Manage the creation, review, approval, issuance, and archival of controlled documents including SOPs, batch records, forms, protocols, and reports.
• Establish electronic document management systems (EDMS) and ensure proper system validation and security controls are in place.
• Lead training initiatives for site personnel on document control processes, document authoring standards, and compliance requirements.
• Coordinate cross-functional document reviews, version control, change management, and timely issuance of current documents to ensure operational readiness.
• Monitor and ensure compliance with controlled document workflows, ensuring timely processing and adherence to procedural timelines.
• Support regulatory inspections, internal audits, and external audits by providing controlled document access, retrieval, and documentation support.
• Maintain accurate and organized archives (both physical and electronic) to ensure data integrity, traceability, and inspection readiness.
• Collaborate with Quality Assurance, Validation, Operations, Engineering, and Regulatory Affairs to ensure alignment of document control processes.
• Continuously improve document control processes, leveraging automation, best practices, and compliance trends to ensure long-term system robustness.

• Bachelor’s degree in Life Sciences, Quality Management, or related field.
• 5+ years of experience in GMP-regulated pharmaceutical document control, preferably in sterile manufacturing.
• Prior experience implementing or managing electronic document management systems (EDMS) strongly preferred.
• Strong understanding of FDA cGMP, ICH, ISO 9001, and data integrity principles.
• Experience supporting regulatory inspections and audits.

• Expertise in controlled document management principles and electronic systems.
• Strong attention to detail, accuracy, and compliance.
• Excellent organizational and time management skills.
• Ability to manage multiple priorities and document workflows simultaneously.
• Strong cross-functional collaboration and communication skills.
• Proficiency in EDMS platforms, document lifecycle management, and version control.
• Ability to work in a greenfield/startup environment and build systems from the ground up.

WhiteCrow Research