Change Control, Continuous Improvement Manager

Change Control Continuous Improvement Manager

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 systemic 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 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.

Job Specifications and Qualifications:

• Associate or Bachelor's degree in Business Administration, Life Sciences, or a related field.
• 34 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., TrackWise, TrackWise 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.

Knowledge & 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.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio) and data visualization tools.
• Ability to work independently, prioritize effectively, and deliver results in a fast-paced, regulated environment.

Education/Experience:

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Business Administration, or a related field required.
• Minimum 46 years of experience in Quality Assurance, Document Control, or Change Control within a regulated pharmaceutical, biotechnology, or medical device environment.
• Minimum 23 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) required.
• 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.
• 34 years of leadership and/or project management experience, including team oversight and cross-functional coordination.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat.

Working Conditions / Physical Requirements:

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