Key Responsibilities and Required Skills for Document Control Manager

🎯 Role Definition

The Document Control Manager is responsible for designing, implementing, and maintaining a robust document and records management program that ensures controlled distribution, revision control, retention, archival, and audit-ready compliance for all controlled documentation across the organization. This role manages both electronic document management systems (EDMS/DMS) and physical records, leads a cross-functional document control team, partners with quality, regulatory, engineering and operations to enforce standards (SOPs, work instructions, policies), and drives continuous improvement of document lifecycle controls to meet ISO, FDA, GxP, and other regulatory requirements.

Core keywords: Document Control Manager, document management, revision control, change control, DMS/EDMS, ISO 9001, GxP, SOPs, records retention, audit readiness, Master Document List, Veeva, MasterControl, SharePoint, Documentum.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Document Controller or Document Control Specialist with proven experience in electronic and manual document control processes.
Quality Assurance Specialist/Coordinator with strong exposure to SOPs, controlled documents, and compliance activities.
Records Manager or Records Supervisor responsible for retention schedules and archival programs.

Advancement To:

Director of Document Control / Records Management
Quality Assurance Manager / Head of Quality Systems
Compliance Manager / Head of Regulatory Affairs

Lateral Moves:

Quality Systems Manager
Regulatory Affairs Specialist
Project Manager (with emphasis on technical documentation or engineering projects)

Core Responsibilities

Primary Functions

Develop, maintain, and enforce the organization's document control policy, procedures and standards (SOPs, naming conventions, metadata taxonomy) to ensure consistent versioning, access control, and audit-readiness across all business units.
Manage the end-to-end document lifecycle for controlled documents including creation, review, approval, change control, release, distribution, obsolescence, archival, and destruction according to retention schedules and regulatory requirements.
Lead and administer the enterprise Document Management System (e.g., MasterControl, Veeva, Documentum, OpenText, SharePoint) configuration, including document workflow design, permissions, metadata schema, templates, and system upgrades/validation.
Maintain and publish the Master Document List (MDL) / Controlled Documents Register, ensuring accuracy of revision statuses, approval dates, owners, and distribution lists to support traceability and audit trails.
Coordinate cross-functional review and approval cycles with SMEs, authors, QA, legal and regulatory stakeholders; manage escalations and enforce SLAs for timely document approvals and releases.
Implement and manage document change control processes (ECNs/RFCs), including impact assessment, cross-reference updates, training notifications, and concurrent revision handling for multi-site operations.
Ensure compliance of controlled documents with applicable regulations and standards (ISO 9001, ISO 13485, FDA 21 CFR Part 11, GxP, GMP) by maintaining validation evidence, electronic signatures, audit logs, and system access controls.
Prepare for and support internal and external audits, supplier audits and regulatory inspections by assembling controlled document packages, demonstrating control mechanisms, and responding to nonconformities and observations.
Supervise, coach and develop the document control team (document controllers, administrators and coordinators); allocate workload, set KPIs, run performance reviews and provide ongoing training on DMS best practices.
Manage and execute records retention and disposition programs ensuring legal, regulatory and business requirements are met; coordinate legal hold processes and forensic retrieval for litigation or regulatory inquiries.
Drive continuous improvement initiatives to reduce document cycle time, increase first-pass approval rates, reduce audit findings and raise user adoption of DMS through process standardization and automation.
Partner with IT, Quality, Engineering and Business Process Owners to implement integrations between the DMS and other enterprise systems (PLM, ERP, CRM), ensuring metadata consistency, secure APIs, and single source of truth for controlled documentation.
Create and deliver training programs, user guides and e-learning modules for authors, reviewers and approvers on documentation standards, templates, system usage and regulatory requirements.
Establish and report document control KPIs and metrics (e.g., time-to-approve, overdue reviews, audit nonconformances, number of controlled documents) to senior management and use metrics to drive corrective actions.
Coordinate the ingestion, indexing and migration of legacy documents and records into the EDMS during system implementations, including quality checks, metadata mapping and remediation of orphaned records.
Ensure document and records security including role-based access controls, secure storage, backup/restore and disaster recovery plans, and periodic user access reviews to preserve confidentiality and integrity.
Manage vendor relationships for outsourced document control services, DMS vendors, scanning and archiving providers; negotiate SOWs, SLAs and ensure vendor compliance to company policies.
Oversee technical writing quality for policies, procedures and product documentation; provide editorial support and ensure documents meet corporate style, legal and regulatory standards prior to issuance.
Lead cross-site document harmonization projects to align documentation across multiple facilities or subsidiaries, manage regional differences, and drive a harmonized global document control approach.
Participate in the implementation, validation and maintenance of electronic signatures, audit trail configuration and compliance features to meet 21 CFR Part 11 or equivalent regulatory frameworks.
Respond to ad-hoc documentation requests from stakeholders, support cross-functional initiatives such as CAPA and change management by providing accurate documentation evidence and controlled document references.
Conduct regular document health checks, risk-based reviews, and gap analyses to proactively identify noncompliant documents, redundant content and opportunities for consolidation or retirement.

Secondary Functions

Support continuous improvement initiatives by identifying automation opportunities (workflow optimization, template automation, metadata enrichment) and partnering with RPA/IT teams.
Provide subject matter expertise for documentation-related CAPAs, root cause analyses, and corrective/preventive actions, ensuring documentation issues are fully resolved and closed.
Assist in the development and maintenance of training records and competency matrices related to document control procedures for internal audits or regulatory inspections.
Facilitate project-specific documentation plans for new product introductions, engineering change rollouts, and facility expansions ensuring documentation readiness for handover.
Coordinate with Legal and Compliance for records required for contracts, third-party agreements, and confidentiality requirements; support FOIA or discovery requests as needed.
Maintain document naming conventions, classification schemes and controlled vocabularies to improve searchability, content discoverability, and SEO for internal knowledge portals.
Support periodic readiness drills for audit and inspection scenarios, including mock audits and documentation mock-ups to test retrieval time and completeness.

Required Skills & Competencies

Hard Skills (Technical)

Expert knowledge of Document Management Systems (DMS / EDMS) such as MasterControl, Veeva Vault, Documentum, OpenText, or enterprise SharePoint administration and customization.
Strong experience with document control standards and regulations: ISO 9001, ISO 13485, FDA 21 CFR Part 11, GxP/GMP, and other industry-specific regulatory frameworks.
Proven ability to design and maintain Master Document Lists, controlled document registers, metadata schemas, and document templates.
Competence in change control processes, revision management, engineering change notices (ECN), and controlled release workflows.
Experience migrating legacy documents to EDMS including metadata mapping, OCR/scanning standards, and quality assurance for migrated records.
Proficiency with audit preparation and support: assembling documentation packages, producing audit trails, and responding to audit findings.
Familiar with records retention scheduling, legal hold processes, archival standards, and secure destruction procedures.
Practical skills integrating DMS with enterprise systems (PLM, ERP, CRM) and managing data exchange, connectors, and API-based workflows.
Hands-on experience with electronic signature configuration, validation protocols, IQ/OQ/PQ documentation and compliance testing.
Advanced proficiency in Microsoft Office (Word, Excel, Visio), Adobe Acrobat (PDF/A, redaction, OCR), and familiarity with document markup/version comparison tools.
Basic SQL or query skills for reporting and extracting data from DMS databases (preferred).
Knowledge of metadata taxonomies, information architecture and search optimization for document discoverability.

Soft Skills

Exceptional attention to detail and a rigorous approach to documentation accuracy, version control and traceability.
Strong leadership and people-management skills; proven ability to lead cross-functional teams and influence without direct authority.
Excellent written and verbal communication; can translate regulatory and technical requirements into clear, user-friendly procedures and training.
Strong stakeholder management and customer service orientation; able to negotiate timelines and priorities with multiple business units.
Analytical and process-improvement mindset with ability to use KPIs to drive decisions and continuous improvement.
Project management skills including planning, prioritization, task delegation, and meeting tight deadlines across concurrent projects.
Problem-solving and escalation management skills during audits, regulatory inquiries or emergency documentation needs.
Training and coaching capabilities to raise organizational document control literacy and DMS adoption.
Adaptability to changing regulatory landscapes and cross-cultural/team environments.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Business Administration, Records/Information Management, Quality Assurance, Life Sciences, Engineering, Library Science or related field; or equivalent professional experience.

Preferred Education:

Bachelor's or Master's degree in Information Management, Quality Systems, Life Sciences, or Engineering plus certifications such as Certified Records Manager (CRM), ISO Lead Auditor, Certified Document Controller or DMS vendor-specific admin certification (MasterControl, Veeva).
Training or certification in project management (PMP, PRINCE2) or process improvement (Six Sigma, Lean) is advantageous.

Relevant Fields of Study:

Records/Information Management
Quality Assurance / Regulatory Affairs
Engineering / Life Sciences / Manufacturing
Business Administration / Library and Information Science

Experience Requirements

Typical Experience Range: 5 - 10+ years in document control, records management or quality systems with at least 2–4 years in a leadership or supervisory role.

Preferred:

Demonstrated experience managing a DMS/EDMS in a regulated environment (medical device, pharmaceutical, biotechnology, aerospace, manufacturing).
Proven track record of supporting regulatory inspections and passing internal/external audits with minimal findings.
Experience implementing document control best practices across multi-site or global operations.