Change 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.  

Essential Duties and Responsibilities:

1. 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. 

2. 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.

3. 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.
• 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., 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 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) 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. 
• 3–4 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.  

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.  

Essential Duties and Responsibilities:

1. 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. 

2. 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.

3. 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.
• 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., 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 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) 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. 
• 3–4 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.