CQV Change Control Program Lead – Onsite Puerto Rico

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

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