Control, Continuous Improvement Manager

Description

Job Purpose:

The Change Control Continuous Improvement Manager is responsible for identifying, developing, and implementing process improvement initiatives within the Change Control and Document Revision functions. This role serves as a subject matter expert (SME) and internal lead for optimizing document lifecycle management, change control workflows, and electronic quality management system (eQMS) performance.

• 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.

• 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 the 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 Nephron and employee information.
• Participate in cross-functional project teams as a quality systems subject matter expert.
• Perform other job-related duties as assigned.

• Associate or Bachelor’s degree in Business Administration, Life Sciences, or a related field.
• 3–4 years of experience in document control and/or Quality Assurance within a regulated environment (pharmaceutical, biotechnology, or related industry).
• Working knowledge of cGMP, FDA regulations, and data integrity principles.
• Minimum 3 years of experience with Document Management Systems (e.g., Track Wise, Track Wise Digital, Dot Compliance, Electronic Batch Records).
• Experience with batch record lifecycle management, including generation, issuance, reconciliation, and archival.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat (PDF workflows).
• Strong attention to detail with excellent organizational and documentation skills.
• Effective written and verbal communication skills.
• Ability to manage multiple priorities, meet deadlines, and work independently in a fast-paced environment.

• 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…