GMP/GxP Change Control Leader – QMS & Process Excellence

Dawar Consulting, Inc.; Santa Monica (CA); Hybrid; USD 96,000 - 107,000; Full time

Benefits offered by this job

Medical

Paid Sick Leave

401 (k)

Job summary

Dawar Consulting, Inc. is assisting a client in Santa Monica with a Hybrid Change Control Owner contract role.

The Senior Specialist will own and manage GMP/GxP change controls across Global and Regional Supply Chain teams and partner with Quality, Process Development, and Manufacturing to meet QMS requirements and timelines. The position requires 5+ years in Change Control within GMP/GxP settings and hands-on experience with Veeva QMS, TrackWise, MasterControl, or Oracle Agile.

Qualifications

• 5+ years of Change Control experience in GMP/GxP environments.
• Hands-on experience with QMS/eQMS systems (Veeva QMS, TrackWise, MasterControl or Oracle Agile).

Responsibilities

• Own and manage GMP/GxP Change Control records from initiation through closure.
• Track approvals, implementation activities, milestones, risks, dependencies and deadlines.
• Coordinate cross-functional meetings and stakeholder communications.
• Ensure change controls meet QMS, compliance and quality requirements.
• Maintain change-control trackers and provide status reporting.
• Identify delays/risks and drive timely escalation and resolution.
• Support continuous improvement of Change Control processes.

Skills

Change Control

GMP/GxP

QMS/eQMS

Cross-Functional Collaboration

Tools

Veeva QMS

TrackWise

MasterControl

Oracle Agile

Job description

Dawar Consulting, Inc. is assisting a client in Santa Monica with a Hybrid Change Control Owner contract role.

The Senior Specialist will own and manage GMP/GxP change controls across Global and Regional Supply Chain teams and partner with Quality, Process Development, and Manufacturing to meet QMS requirements and timelines. The position requires 5+ years in Change Control within GMP/GxP settings and hands-on experience with Veeva QMS, TrackWise, MasterControl, or Oracle Agile.