Intellectt Inc · 7 hours ago
Change Control Project Manager
Boston, MA
Contract
Onsite
Mid, Senior Level
6+ years expIntellectt Inc is seeking a Change Control Project Manager responsible for managing GMP Change Controls across cross-functional teams in a Cell & Gene Therapy program. The role requires close collaboration with Quality, Manufacturing, Engineering, and Technical Operations to ensure timely execution of change controls and compliance with regulatory requirements.
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Hiring Manager
Yaman Kalyani
Responsibilities
Own and manage end-to-end Change Control execution , including timelines, milestones, dependencies, and deliverables
Track and drive completion of change actions across cross-functional stakeholders
Identify interdependencies and critical path activities related to Change Controls
Monitor risks, issues, and mitigation plans associated with changes
Maintain integrated project plans related to Change Controls
Track and report scope, schedule, milestones, and status
Prepare and maintain:
Action logs
Risk registers
Project dashboards and trackers
Communicate status, risks, and mitigation plans clearly to stakeholders
Partner closely with Quality, Manufacturing, Engineering, Validation, and Technical Operations
Facilitate meetings, prepare agendas, document minutes, and manage task follow-ups
Ensure alignment with GMP requirements and internal SOPs
Perform all activities in accordance with GxP, SOPs, and regulatory requirements
Support inspections and audits as related to Change Control documentation
Apply strong risk management principles to change execution
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
Recent, hands-on Change Control management experience is REQUIRED
6+ years of experience managing projects or change initiatives in a biopharmaceutical or biotech environment
Strong GMP knowledge, including FDA regulations (21 CFR Part 211), EU GMP, and ICH Q10
Experience working in cross-functional, matrixed environments
Ability to manage multiple changes simultaneously and adapt to shifting priorities
Proficiency in Microsoft Office Suite (Project, Excel, PowerPoint, Word, SharePoint, Outlook)
Preferred
Experience in Cell Therapy or Gene Therapy environments
Background in Quality, Technical Operations, or Manufacturing Support
Familiarity with risk management tools and change impact assessments
Experience with PM or tracking tools such as Smartsheet, Power BI, or similar is a plus
Company
Intellectt Inc
Intellectt Inc.
1001-5000 employees
H1B Sponsorship
Intellectt Inc has a track record of offering H1B sponsorships. Please note that this does not
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2025 (271)
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Funding
Current Stage
Late StageCompany data provided by crunchbase