Document Control Manager

Heartland FPG • Indianapolis, IN

9d • Onsite

About The Position

The Manager of Document Control is accountable for the leadership, governance, and performance of the organization’s document control program within a regulated manufacturing environment. This role ensures that all controlled documents and records are accurate, compliant, and effectively managed throughout their lifecycle in alignment with regulatory requirements and internal quality systems. The Manager serves as the subject matter expert (SME) for document control, establishing standards, driving consistency, and ensuring that documentation practices support operational excellence, regulatory compliance, and audit readiness. This position works cross-functionally with Quality, Engineering, Operations, and Maintenance to ensure documentation is clear, accessible, and aligned with standardized ways of working. This role focuses on strategic oversight, governance, and decision-making. Document creation and operational execution are primarily delegated to SMEs and cross-functional contributors, while the Manager ensures quality, compliance, and alignment with organizational objectives. The Manager is accountable for document integrity, audit outcomes, system effectiveness, and long-term strategy and scalability to support organizational growth and regulatory expectations.

Requirements

• Bachelor’s degree in Engineering, Science, Business, or related field
• 5+ years of experience in document control, quality systems, or regulated manufacturing environments
• Strong knowledge of document lifecycle management, document control systems, and regulatory requirements (FDA, cGMP, SQF, ISO)
• Experience with Quality Management Systems (QMS) and document management platforms
• Demonstrated ability to lead cross-functional teams, manage enterprise initiatives, and strategically oversee delegated resources
• Proven ability to drive process standardization, long-term program scalability, and compliance across multiple sites
• Strong organizational, communication, and problem-solving skills
• Ability to influence stakeholders and drive compliance across multiple departments

Responsibilities

• Lead the enterprise document control program, including governance frameworks, policies, procedures, and long-term strategy
• Oversee the full document lifecycle: creation, review, approval, version control, issuance, revision, archival, and retention
• Establish and enforce document standards aligned with FDA, cGMP, SQF, and internal quality systems
• Ensure controlled documents are accurate, current, and available at point of use
• Lead document change control processes, ensuring proper evaluation, approval, and implementation of revisions
• Partner with cross-functional teams to ensure document updates reflect operational and regulatory changes
• Identify compliance risks and drive corrective and preventive actions (CAPA)
• Serve as the primary SME for document control during internal, customer, and regulatory audits
• Ensure continuous inspection readiness across all document systems
• Lead responses to audit findings related to documentation and records
• Provide guidance, oversight, and mentorship to SMEs, document authors, reviewers, and stakeholders, ensuring adherence to standards without personally executing all document creation
• Drive alignment on best practices, standardization, simplification, and scalability across sites
• Identify and implement improvements in document management systems and workflows
• Drive standardization, simplification, and scalability across sites
• Support digital initiatives related to QMS and document control systems
• Monitor and report KPIs related to document compliance, timeliness, and effectiveness
• Provide functional leadership for document control processes, including workload prioritization, delegation, and oversight of documents control resources
• Establish decision-making standards and approval frameworks for document control processes
• Drive measurable performance improvements through key metrics and reporting to executive leadership

Benefits

• excellent compensation and benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Manager