Change Control Owner

Dawar Consulting, Inc.; Santa Monica (CA); On-site; 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

Our client, a world leader in biotechnology and life sciences, is looking for a “Change Control Owner”.

Location: Hybrid in Santa Monica; will transition to El Segundo in 2027

Job Duration: Long-Term Contract (Possibility Of Extension)

Rate: $70-$78/hr on W2

Company Benefits

• Medical
• Paid Sick Leave
• 401 (k)

About the Role

The Senior Specialist will work closely with the GSC organization to own and manage Supply Chain initiated change controls by our Global and Regional Supply Chain teams as well partner with other Technical Operations functions: Quality, Process Development, and Manufacturing. These partnerships ensure that GSC owned change controls meet and/or exceed Quality Management System requirements, meet compliance requirements, and are implemented flawlessly per established timelines.

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.

Qualifications

• 5+ years of Change Control experience, preferably in a GMP/GxP environment.
• Hands-on experience with QMS/eQMS systems such as Veeva QMS, TrackWise, MasterControl or Oracle Agile preferred.