Document Control Lead

The Document Controls Lead will support a major EPCMV pharmaceutical capital project in Lebanon, Indiana, with responsibility for leading document control strategy, execution, governance, and turnover readiness across the project lifecycle. This role will oversee the transition of project documentation from contracted partners, vendors, construction teams, automation/IT teams, and commissioning groups to the client in a controlled, compliant, and audit-ready manner.

The ideal candidate will bring strong experience in pharmaceutical document turnover, paperless document control systems, and large-scale capital project environments exceeding $1B in value. This is a site-based role requiring presence in Lebanon, Indiana for the duration of the assignment, currently anticipated to be approximately 18 months.

Key Responsibilities

• Lead the document control function for a large-scale pharmaceutical manufacturing capital project.
• Oversee document management processes across engineering design, vendor packages, construction, IT and automation, commissioning, qualification, and final turnover.
• Manage the transition of documentation from contracted partners and suppliers to the client, ensuring completeness, accuracy, traceability, and compliance with project requirements.
• Establish and maintain document control procedures, workflows, naming conventions, metadata standards, review cycles, approval routing, and retention requirements.
• Coordinate with EPCM, design, construction, vendors, automation, C&Q, quality, and client-side teams to ensure documentation is properly generated, reviewed, approved, and archived.
• Monitor document deliverables against project milestones, turnover schedules, and readiness requirements.
• Support the development and maintenance of document registers, turnover matrices, vendor document schedules, and completion dashboards.
• Ensure project documentation aligns with pharmaceutical quality, regulatory, validation, and commissioning expectations.
• Identify gaps, risks, or delays in documentation readiness and work with project stakeholders to resolve issues.
• Lead document control meetings, status reviews, and readiness discussions with internal and external project partners.
• Support handover and turnover planning, including system-based documentation packages, vendor turnover files, construction records, automation documentation, commissioning records, and qualification deliverables.
• Provide guidance and oversight to document controllers, project team members, and contracted partners on required document control standards and systems.
• Maintain strong document governance to support audit readiness, operational handover, and long-term client ownership of records.

Required Experience

• Significant document control leadership experience on large-scale capital projects, preferably within pharmaceutical, biotechnology, life sciences, or other regulated manufacturing environments.
• Demonstrated experience with pharmaceutical document turnover from contractors, vendors, and project partners to an owner/client organization.
• Experience supporting document control across multiple project modalities, including: Engineering design documentation, Vendor documentation and equipment packages, Construction documentation, IT and automation documentation, Commissioning and qualification documentation, Turnover and handover packages
• Prior experience working on large capital projects valued greater than $1B (strongly preferred).
• Strong working knowledge of paperless document control, turnover, and project information management systems currently used on major capital projects.
• Familiarity with regulated documentation expectations, including traceability, version control, approval workflows, audit readiness, and lifecycle records management.
• Experience coordinating with EPCM firms, general contractors, trade partners, vendors, commissioning teams, automation teams, quality teams, and owner-side stakeholders.
• Ability to work in a fast-paced, complex project environment with multiple workstreams, stakeholders, and documentation sources.

Preferred Qualifications

• Experience supporting pharmaceutical manufacturing, advanced manufacturing, biologics, sterile fill-finish, API, device assembly, packaging, or similar regulated facility projects.
• Prior owner-side or client-representative experience.
• Experience with digital turnover, paperless validation, electronic document management systems, and project completions platforms.
• Strong understanding of commissioning, qualification, validation, and GMP documentation requirements.
• Experience leading or mentoring document control teams on large projects.

Key Skills and Competencies

• Strong leadership and stakeholder coordination skills.
• Highly organized with strong attention to detail.
• Ability to identify documentation gaps and drive corrective action.
• Strong understanding of document lifecycle management from creation through final turnover.
• Comfortable working with technical, construction, automation, quality, and commissioning stakeholders.
• Strong communication skills with the ability to clearly explain document requirements and status to project leadership.
• Ability to manage competing priorities, deadlines, and documentation dependencies.
• Practical understanding of how document control supports project delivery, compliance, handover, and operational readiness.