Job Title: Change Control Project Manager
Location: Boston, MA
Job Type: Contract
Industry: Biopharmaceutical / Cell & Gene Therapy
Job Description
We are seeking an experienced Change Control Project Manager to support cross-functional project teams executing change controls within a biopharmaceutical environment. The Project Manager will be responsible for tracking and reporting project scope, timelines, milestones, risks, and deliverables associated with the Cell & Gene Therapy Type 1 Diabetes (T1D) team.
The ideal candidate will have a strong technical background, extensive biopharmaceutical project management experience, solid knowledge of GMP requirements, and an understanding of the drug development lifecycle through commercialization. Experience with cell and/or gene therapy and risk management is highly desirable.
Key Responsibilities
Partner with functional area leads to maintain and actively monitor integrated project plans.
Identify and communicate project interdependencies and critical-path activities.
Track key milestones, decision points, deliverables, and timelines.
Work with cross-functional project team members to drive timely completion of change controls.
Communicate project status, objectives, risks, issues, and mitigation plans to internal teams and key stakeholders.
Organize and maintain project communications, including meeting agendas, meeting minutes, action items, and task lists.
Develop and maintain risk analyses, mitigation strategies, project action logs, and risk registers.
Develop and implement project management tools and templates to support change-control activities.
Manage multiple priorities while adapting to changing project requirements and business needs.
Ensure project activities are performed in accordance with established SOPs and applicable GxP requirements.
Facilitate cross-functional meetings and provide clear project updates to stakeholders at various organizational levels.
Required Qualifications
Bachelor's degree in Engineering, Life Sciences, or a related technical field.
8+ years of experience in the biopharmaceutical industry.
6+ years of project management experience within biopharmaceutical product development/manufacturing.
Strong working knowledge of biotechnology, GMPs, and the drug development lifecycle through commercialization.
Experience managing change control projects in a regulated biopharmaceutical environment.
Strong understanding of risk assessment and risk mitigation.
Strong knowledge of regulatory requirements, including FDA, 21 CFR Part 211, EU GMP, and ICH Q10.
Proven ability to work effectively within cross-functional and matrixed organizations.
Strong analytical, problem-solving, and critical-thinking skills.
Excellent written and verbal communication skills.
Strong presentation, facilitation, and stakeholder-management skills.
Ability to prioritize multiple projects and balance competing priorities.
Preferred Qualifications
Experience with Cell & Gene Therapy (CGT) methodologies.
Experience supporting T1D / diabetes-related cell therapy programs is a plus.
Experience with project management tools such as Microsoft Project, Smartsheet, Power BI, or SharePoint.
Strong proficiency with Microsoft Office Suite, including Project, PowerPoint, SharePoint, Word, Excel, and Outlook.
Change Control Project Manager • Boston, MA, United States
CGS is seeking an eDiscovery Project Manager to join our team supporting the legal organization within a large Federal agency.CGS brings motivated, highly skilled, and creative people together to s... Show more
Location: Remote or Boston, MA.Digital transformation in bank setting.Technical IT Program/Project Management.Experience w/ Technology Automation / Digital efforts.Banking / Financial Services Indu... Show more
The Middlesex Corporation is a nationally recognized and award-winning leader in the heavy civil construction industry.Since 1972, the family business founded by Robert W.Pereira has developed an e... Show more
At HDR, our employee-owners are fully engaged in creating a welcoming environment where each of us is valued and respected, a place where everyone is empowered to bring their authentic selves and n... Show more
ERP Program/Change Manager, Finance.Location: Onsite 5 days Andover, MA (locals only).Visa Restrictions: No Sponsorship.ERP Finance Leadership: Proven experience managing large-scale ERP initiative... Show more
Project Manager - LIMS/Validation.Location: Cambridge, MA (Hybris) Duration: Long Term Primary Skills: Project Manager, Validation, Project Management.Technical PM with the following background, A... Show more
Associate Director Of Change Management.The Associate Director of Change Management- R&D will be responsible for overseeing and managing the change management processes related to ongoing and futur... Show more
The ideal candidate should have experience managing software products and/or leading product development, a demonstrated ability to collaborate, and drive progress.Preferably, this individual will ... Show more
MassIT is hiring a Change Management and Operations Manager for a two-year fellowship aimed at advancing our technology modernization initiatives through change management and customer outreach.Mas... Show more
WSP is seeking a Document Control Manager to join our Project Controls team in Boston, MA.Influence the narrative by understanding what needs to be done to support the project vision and initiative... Show more
Client is seeking a full-time contract Project Manager based in the U.These projects may be a full company integration or an asset integration.Note: This is a primarily remote position with occasio... Show more
Odyssey Systems is seeking a dynamic.This new position plays a critical role in overseeing corporate project management, ensuring that initiatives are effectively executed and aligned with Odyssey'... Show more
Help run day to day initiatives, treating initiatives like mini projects with timelines, stakeholder interviews, documentation, and day to day responsibilities.As a Project Manager, you will partne... Show more
RE:FAB IS A FULL-SERVICE PAINTING AND RENOVATION COMPANY BASED OUT OF LAKEVILLE, MA WHICH SERVICES NEW ENGLAND PROJECTS.RE:FAB OFFERS A FAST PACED, PROFESSIONAL, AND RESPECTFUL WORKING ENVIRONMENT;... Show more
The Manager, Quality Control position ensures the products are compliant to internal and external standards, safety regulations, and customer expectations by developing processes, inspecting output... Show more
The Quality Manager will be responsible for providing Quality leadership, managing, and developing QA teams that support site, customer and manufacturing operations, which includes coordination of ... Show more
Technical PM with the following background:.LIMS with integration knowledge.Required skills: Manager, Validation, Project Management.Additional skills: Validation Engineer, Product Manager, Project... Show more
Intermediate It Project Manager.Perfict Global is a leading IT consulting services provider focused on providing innovative and successful business workforce solutions to Fortune 500 companies.Our ... Show more
Would you like to join a truly international, talent driven company that values Safety, Ethics, Quality, Innovation and Employee Opportunity?.Otis Elevator Company is searching for a highly motivat... Show more
LIMS with Integration knowledge.Primary Skills: Manager, Validation, Project Management. Show more
