GxP Change Control Lead – Biotech

Doist; Santa Monica (CA); Hybrid; USD 200,579,000 - 223,502,000; Full time

Benefits offered by this job

Medical

Paid Sick Leave

401 (k)

Job summary

Doist is seeking a Change Control Owner in Santa Monica, CA, with hybrid work arrangements. This long-term contract role pays $70–$78 per hour on a W-2 basis.

You will lead GMP/GxP change controls within the GSC/Quality ecosystem and collaborate with Regulatory, Process Development, and Manufacturing teams. The Senior Specialist will ensure compliance with QMS requirements, track milestones, and drive timely escalation of risks to maintain project timelines.

Qualifications

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

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 experience

GMP/GxP environment

Tools

Veeva QMS

TrackWise

MasterControl

Oracle Agile

Job description

Doist is seeking a Change Control Owner in Santa Monica, CA, with hybrid work arrangements. This long-term contract role pays $70–$78 per hour on a W-2 basis.

You will lead GMP/GxP change controls within the GSC/Quality ecosystem and collaborate with Regulatory, Process Development, and Manufacturing teams. The Senior Specialist will ensure compliance with QMS requirements, track milestones, and drive timely escalation of risks to maintain project timelines.