Biotech Change Control Project Lead

TalentBurst, an Inc 5000 company; Vacaville (CA); On-site; USD 34,440 - 52,348; Full time

Job summary

TalentBurst is seeking a Project Administrator in Vacaville, CA, a 6‑month engagement with possible extension, to support Technology Transfer and CAPEX projects. You will manage Change Controls from initiation through closure and coordinate cross‑functional teams to ensure compliant changes are approved on schedule and project deliverables meet timelines.

The role requires at least 2 years in GMP environments, experience with eQMS platforms, and strong organizational skills to drive timelines

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or related discipline preferred.
• 2 years of experience in biotechnology, pharmaceutical, medical device, or other GMP-regulated industries.
• Experience managing or coordinating Change Controls in a complex regulated environment.
• Experience with electronic Quality Management Systems (eQMS) and Change Control platforms (Veeva/TrackWise/MasterControl) preferred.

Responsibilities

• Own and manage Change Controls supporting Technology Transfer projects.
• Drive Change Controls through full lifecycle with timely actions, approvals, and implementation.
• Monitor timelines, identify risks, and escalate issues as needed.
• Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams.
• Schedule and facilitate project meetings, document minutes, and track actions to completion.
• Support Project Managers with planning, status tracking, and cross-functional coordination.
• Maintain project documentation and provide regular updates on Change Control status.
• Assist with reporting, milestone tracking, and stakeholder communications.
• Ensure Change Controls and project documentation comply with site procedures and cGMP requirements.
• Maintain audit-ready records and support inspection readiness and regulatory compliance activities.

Skills

Change Control

Project Coordination

GMP Compliance

Education

Bachelor's degree in Life Sciences

Tools

Veeva

TrackWise

MasterControl

Job description

TalentBurst is seeking a Project Administrator in Vacaville, CA, a 6‑month engagement with possible extension, to support Technology Transfer and CAPEX projects. You will manage Change Controls from initiation through closure and coordinate cross‑functional teams to ensure compliant changes are approved on schedule and project deliverables meet timelines.

The role requires at least 2 years in GMP environments, experience with eQMS platforms, and strong organizational skills to drive timelines