Lifecycle Change Control Coordinator - Life Sciences

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

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.