Change Control, Continuous Improvement Manager

Identify, develop, and implement process improvement initiatives within the Change Control and Document Revision functions. Serve as a subject matter expert and internal lead for optimizing document lifecycle management, change control workflows, and electronic quality management system (eQMS) performance.

Responsibilities

• Continuous Improvement — Change Control and Document Revision
  • Lead continuous improvement efforts for change management processes, including initiation, impact assessment, approval routing, implementation, and closure.
  • Analyze data to identify bottlenecks, recurring delays, incomplete submissions, and compliance risks.
  • Establish and monitor key performance indicators (KPIs) for change control and document revision cycle time, on-time closure rates, and rejection rates.
  • Collaborate with cross-functional stakeholders (Manufacturing, Engineering, Regulatory Affairs, Validation, and Quality) to ensure change control requirements are clearly understood and consistently applied.
  • Conduct root cause analysis on change control deficiencies and implement corrective process improvements.
• eQMS System Optimization & Data Analysis
  • Serve as a functional lead and SME for the eQMS (Dot Compliance) as it relates to document control and change control modules.
  • Generate and analyze quality system reports and dashboards to support management review, audit readiness, and performance trending.
  • Identify and drive system configuration improvements to enhance workflow automation, routing efficiency, and compliance controls.
  • Develop and maintain eQMS user training materials and deliver training to document control and change control end users.
• Training & Change Management
  • Develop and deliver training programs on document control and change control processes, tools, and regulatory expectations.
  • Champion a culture of quality and continuous improvement across the organization by communicating process changes clearly and effectively.
  • Serve as a resource and mentor to Document Control and Change Control staff on best practices and quality system requirements.
• Supplemental Functions
  • Assist in Quality Assurance approval of Change controls in Quality Management System for documents, materials, and equipment/process changes.
  • Review revision of controlled documents to ensure compliance with regulatory submissions and requirements.
  • Participate in management review meetings by presenting quality metrics and improvement initiative status updates.
  • Maintain a high level of confidentiality with respect to company and employee information.
  • Participate in cross-functional project teams as a quality systems subject matter expert.
  • Perform other job-related duties as assigned.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Business Administration, or a related field required.
• Minimum 4–6 years of experience in Quality Assurance, Document Control, or Change Control within a regulated pharmaceutical, biotechnology, or medical device environment.
• Minimum 2–3 years of demonstrated experience leading or supporting continuous improvement initiatives within a quality systems function.
• Hands-on experience with eQMS platforms (e.g., TrackWise, Veeva Vault, MasterControl, Dot Compliance).
• Demonstrated experience managing document control processes, including document lifecycle management, data integrity, and records retention.
• Experience with batch record management, including generation, issuance, reconciliation, and archival.
• 3–4 years of leadership and/or project management experience, including team oversight and cross-functional coordination.
• Working knowledge of cGMP, FDA regulations, and data integrity principles.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio) and Adobe Acrobat.

Skills

• In-depth knowledge of document control and change control principles within a regulated pharmaceutical, biotechnology, or medical device environment.
• Strong understanding of cGMP, FDA 21 CFR Parts 211 and 820, ICH Q10, ISO 9001, and ISO 13485 regulatory requirements.
• Demonstrated experience applying continuous improvement methodologies to quality system processes.
• Proficiency with eQMS platforms (TrackWise, TrackWise Digital, Dot Compliance) including workflow configuration and reporting.
• Strong data analysis skills with the ability to translate metrics into actionable improvement plans.
• Excellent technical writing skills with experience authoring SOPs, work instructions, and process maps.
• Strong project management skills with the ability to lead multiple improvement initiatives simultaneously.
• Effective communication and facilitation skills, with the ability to influence cross-functional stakeholders without direct authority.
• High attention to detail and commitment to accuracy, traceability, and compliance.
• Ability to work independently, prioritize effectively, and deliver results in a fast-paced, regulated environment.

Schedule

• Standard work schedule is Monday through Friday, 8-hour shifts; additional hours may be required based on business demands.

Working Conditions

• Frequent standing, sitting, walking, typing, and occasional bending and lifting of up to 40 lbs. throughout the facility.
• Ability to adapt to changing priorities and shift focus to meet evolving organizational and business needs.
• May be required to wear appropriate personal protective equipment (PPE) in designated areas.