Change Control Program Manager

Job Description

Title: Change Control Program Manager

Location: East of Puerto Rico

Work Schedule: 100% Onsite

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.

Full-time