Project Administrator

SoTalent; Vacaville (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

SoTalent is seeking a Project Administrator to support Technology Transfer and CAPEX projects within a regulated biopharmaceutical manufacturing environment. You will focus on Change Control management, project coordination, documentation, compliance and cross-functional delivery.

Work with Project Managers, Quality, Manufacturing, Engineering, Validation, Regulatory and Supply Chain teams to ensure on-time, compliant project execution and audit-ready documentation.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, or related field.
• 2+ years of experience in biotechnology, pharmaceutical, medical device or other cGMP environments.
• Direct experience coordinating Change Controls and Quality Systems.
• Experience with eQMS platforms such as Veeva, TrackWise, MasterControl or similar.
• Understanding of cGMP requirements and regulated manufacturing environments.
• Strong project coordination, organisational and stakeholder management skills.
• Excellent written and verbal communication abilities.
• Ability to manage multiple projects and priorities with accuracy and compliance.
• Exceptional attention to detail and documentation discipline.

Responsibilities

• Manage Change Controls throughout the full project lifecycle from initiation to closure.
• Coordinate action items, approvals and implementation to keep projects on schedule.
• Monitor timelines, identify risks and escalate issues proactively.
• Coordinate with cross-functional teams for compliant change implementation.
• Schedule and facilitate project meetings, prepare minutes and track actions.
• Support project planning, status tracking, risk management and stakeholder coordination.
• Maintain audit-ready project documentation and records.
• Prepare project status reports and milestone updates for stakeholders.
• Ensure records and Change Controls comply with SOPs and cGMP requirements.
• Support inspection readiness and regulatory compliance activities.
• Drive accountability to achieve milestones and business objectives.

Skills

Change Controls

Project coordination

Stakeholder management

Documentation discipline

Written and verbal communication

Attention to detail

Education

Bachelor's degree in Life Sciences/Biotechnology/Engineering/Quality/Business Administration

Tools

eQMS

Veeva

TrackWise

MasterControl

Job description

Industry: Biotechnology / Pharmaceuticals / Life Sciences / Biomanufacturing

About the Role

A global life sciences organisation is seeking a Project Administrator to support Technology Transfer and CAPEX projects within a highly regulated biopharmaceutical manufacturing environment.

The role focuses on Change Control management, project coordination, documentation, compliance and cross-functional delivery, working closely with Project Managers, Quality, Manufacturing, Engineering, Validation, Regulatory and Supply Chain teams.

Key Responsibilities

• Manage Change Controls throughout the full project lifecycle, from initiation through final closure.
• Coordinate action items, approvals and implementation activities to ensure projects remain on schedule.
• Monitor project timelines, identify risks and bottlenecks, and elevate issues proactively.
• Coordinate with cross-functional teams to support effective and compliant change implementation.
• Schedule and facilitate project meetings, prepare minutes and track actions through completion.
• Support project planning, status tracking, risk management and stakeholder coordination.
• Maintain accurate, complete and audit-ready project documentation.
• Prepare project status reports, milestone updates and stakeholder communications.
• Ensure project records and Change Controls comply with applicable SOPs and cGMP requirements.
• Support inspection readiness and regulatory compliance activities.
• Drive accountability across stakeholders to ensure project milestones and business objectives are achieved.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business Administration or a related field, or equivalent practical experience.
• 2+ years of experience in biotechnology, pharmaceutical, medical device or another cGMP-regulated manufacturing environment.
• Direct experience coordinating or managing Change Controls and Quality Systems.
• Experience with electronic Quality Management Systems (eQMS) and platforms such as Veeva, TrackWise, MasterControl or similar.
• Understanding of cGMP requirements, Change Control processes and regulated manufacturing environments.
• Strong project coordination, organisational and stakeholder management skills.
• Excellent written and verbal communication abilities.
• Ability to manage multiple projects and priorities while maintaining accuracy and compliance.
• Exceptional attention to detail and strong documentation discipline.

Preferred Background

• Quality Assurance / Quality Systems / Compliance
• Pharmaceutical or Biotech Manufacturing
• Engineering or Validation
• Project Administration / Project Coordination

Biotechnology | Pharmaceuticals | Life Sciences | Biomanufacturing | Quality & Compliance | Technology Transfer | Project Management