Change Control, Continuous Improvement Manager
Nephron Pharmaceuticals
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.
- 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.
- 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.
- 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.
- 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.
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