KH
Project Specialist
Katalyst Healthcares & Life Sciences
🇺🇸 United States
Hybrid
Manager or above
2 months ago
- GMP
- Regulatory Compliance
- Veeva
2 months ago
The Project Administrator supports Technology Transfer and CAPEX projects by managing and coordinating Change Controls from initiation through closure. This role works closely with Project Managers and cross-functional teams to ensure changes are executed compliantly, approvals are obtained on schedule, and project deliverables are completed on time. The Project Administrator serves as a key driver of Change Control execution, timeline management, and team coordination within a GMP-regulated biopharmaceutical environment.
Responsibilities:
Change Control Management:
- Own and manage Change Controls supporting Technology Transfer projects.
- Drive Change Controls through the full lifecycle, ensuring timely completion of actions, approvals, and implementation activities.
- Monitor timelines, identify risks or delays, and escalate issues as needed.
- Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams to support successful change implementation.
Project Administration & Coordination:
- Schedule and facilitate project meetings, document meeting minutes, and track action items to completion.
- Support Project Managers with project planning, status tracking, and cross-functional coordination.
- Maintain project documentation and provide regular updates on project and Change Control status.
- Assist with project reporting, milestone tracking, and stakeholder communications .
Compliance & Execution:
- Ensure Change Controls and project documentation comply with site procedures and cGMP requirements.
- Maintain accurate, complete, and audit-ready records.
- Support inspection readiness and regulatory compliance activities.
- Drive accountability across stakeholder groups to meet project timelines and business objectives.
Core Competencies:
- Strong understanding of Change Control processes and quality systems.
- Familiarity with cGMP requirements and regulated manufacturing environments.
- Excellent organizational, communication, and stakeholder management skills.
- Ability to manage multiple priorities and drive actions to completion across cross-functional teams.
- Strong attention to detail and ability to maintain compliant documentation.
Preferred Background:
- Quality Assurance
- Compliance / Quality Systems
- Biotech or Pharmaceutical Manufacturing
- Engineering or Validation
- Technology Transfer Support
- Project Administration or Project Coordination
Requirements:
- Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or a 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 such as Veeva, TrackWise, MasterControl, or similar systems is strongly preferred.
Project Specialist · Katalyst Healthcares & Life Sciences