Change Control Program Manager

ProQuality Network; Northern (KY); Hybrid; USD 96,000 - 152,000; Full time

Job summary

ProQuality Network is seeking a Change Control Program Manager to support a client’s Validation Team in a regulated pharmaceutical manufacturing setting. The role oversees the Change Control lifecycle, ensuring compliance with commissioning, qualification, and validation procedures and risk-based validation practices.

The position requires strong technical expertise in commissioning and qualification activities, stakeholder coordination, and project execution within cGMP operations, with onsite

Qualifications

• Bachelor’s or Master’s degree in Engineering, Microbiology, Biotechnology, or related science field.
• Five or more years of CQV experience in drug product manufacturing environments.
• Strong knowledge of Validation Lifecycle Management and risk-based qualification.
• Experience managing Change Control processes in pharma.
• Proven project management and cross-functional collaboration.

Responsibilities

• Lead and administer Validation Assessment Forum with agenda, meetings, action tracking, and follow-ups.
• Be primary contact for Validation Assessment requestors and Change Control Owners.
• Coordinate and schedule validation assessments based on priorities and risk.
• Maintain Validation Assessment Smartsheet with status, due dates, ownership, and escalations.
• Assist with Change Control overview presentations and initial assessment processes.
• Compile Change Control Validation Plans from Validation SMEs and FTEs.
• Oversee execution of validation-related actions within approved Change Controls.
• Monitor validation activities and identify risks impacting timelines, quality, or deliverables.
• Maintain communication with Validation Teams, owners, stakeholders, and leadership.
• Support continuous improvement of Change Control processes and performance metrics.

Skills

Project management

Stakeholder coordination

Regulatory knowledge

Communication

Education

Bachelor’s or Master in Engineering/Science

Tools

TrackWise

Kneat

CDOCS

Smartsheet

Job description

Employment Type: Contract through ProQuality Network

Position Overview

ProQuality Network is seeking a highly qualified Change Control Program Manager to support our client’s Validation Team activities related to the Change Control Program within a regulated pharmaceutical manufacturing environment. The selected professional will serve as a Project Manager responsible for overseeing the Change Control lifecycle for the Validation Team, ensuring compliance with validation procedures, commissioning and qualification requirements, and risk-based validation practices.

This role requires strong technical expertise in commissioning, qualification, validation lifecycle management, stakeholder coordination, and project execution within cGMP-regulated operations.

Key Responsibilities

• Lead and administer the Validation Assessment Forum, including agenda preparation, meeting facilitation, action tracking, and follow-up activities.
• Serve as the primary point of contact for Validation Assessment requestors and Change Control Owners.
• Coordinate and schedule validation assessments based on business priorities, due dates, resource availability, and operational risk.
• Maintain and administer the Validation Assessment Smartsheet, ensuring accurate tracking of assessment status, ownership, due dates, dependencies, action items, and escalations.
• Assist with Change Control overview presentations and support the initial assessment process to ensure proper stakeholder involvement and technical alignment.
• Compile and prepare Change Control Validation Plans using technical input provided by Validation SMEs and Full-Time Employees (FTEs).
• Oversee the execution and progress of validation-related actions associated with approved Change Controls.
• Monitor validation activities and identify potential risks that may impact timelines, compliance, quality, or project deliverables.
• Maintain effective communication with Validation Teams, Change Control Owners, technical stakeholders, and leadership regarding priorities, risks, dependencies, and project status.
• Support continuous improvement initiatives related to Change Control processes, validation activities, and performance metrics.
• Develop and maintain performance metrics related to Validation Team support activities, including re-assessment trends, root cause analysis, turnaround time, and delivery performance.
• Act as a liaison between Validation Teams and Change Control Owners to ensure timely communication, issue resolution, and alignment with validation strategies.

Qualifications & Preferred Experience

• Bachelor’s or Master’s degree in Engineering, Microbiology, Biotechnology, or a related Science field.
• Minimum of five (5) years of experience in Commissioning, Qualification, and Validation (CQV), preferably within Drug Product manufacturing environments.
• Strong understanding of Validation Lifecycle Management, regulatory requirements, and risk-based qualification approaches.
• Experience managing Change Control processes and validation-related projects within the pharmaceutical industry.
• Demonstrated project management and stakeholder coordination experience in regulated manufacturing environments.
• Strong verbal and written communication skills with the ability to collaborate across multiple functional areas.
• Ability to manage multiple priorities and work independently in fast-paced project environments.
• Experience with the following systems is highly preferred:
• CDOCS
• TrackWise
• Kneat
• Smartsheet

Scope of Work

The selected resource will support Change Control Program activities associated with cGMP automation systems, equipment, facilities, and clean utilities operations within a pharmaceutical manufacturing environment.

Responsibilities will include oversight of Change Control activities in alignment with risk-based Commissioning, Qualification, and Validation processes while ensuring compliance with applicable validation procedures and lifecycle requirements.

The Validation Team currently assesses approximately four (4) Change Controls per week.

Additional Information

• Validation SMEs and FTEs will remain responsible for technical assessment conclusions and technical content supporting Validation Plans.
• Change Control Owners will remain responsible for the accuracy, completeness, scope, timing, and execution of assigned Change Control actions.
• This is a fully onsite position located in the East region of Puerto Rico.