Dexian · 14 hours ago
Change Control Manager (Pharmaceuticals)
Cambridge, MA
Contract
Onsite
Senior Level, Lead/Staff
$65/hr - $69/hr
8+ years expDexian is a leading provider of staffing, IT, and workforce solutions. They are seeking a Senior Change Management Project Manager to support cross-functional teams in executing and overseeing change control initiatives within the Cell and Gene Therapy T1D program.
ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency
Hiring Manager
Prathamesh Waghmode
Responsibilities
Collaborate closely with functional leads to develop, maintain, and actively manage integrated project plans
Identify interdependencies and critical path activities across change control projects
Own and author change controls, managing them through the full lifecycle to completion
Monitor milestones and decision points, proactively driving accountability and timely execution
Communicate project status, risks, mitigation strategies, and key updates to stakeholders at all levels
Facilitate team meetings and maintain documentation including agendas, minutes, action logs, and risk registers
Develop and implement project management tools, templates, and tracking systems to support change control activities
Ensure all responsibilities are performed in compliance with established SOPs and GxP requirements
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related discipline
Minimum 8 years of experience in the biopharmaceutical industry
At least 6 years of project management experience supporting biopharmaceutical products
Direct experience managing and authoring change controls within a GMP-regulated environment (required)
Strong understanding of biotechnology processes, GMP regulations, and the drug development lifecycle
Experience working in cross-functional, matrixed organizations with competing priorities
Proficiency in Microsoft Office Suite (Project, Excel, PowerPoint, SharePoint, Outlook); familiarity with Smartsheet, Power BI, or similar PM tools preferred
Excellent written and verbal communication skills, including presentation and stakeholder engagement capabilities
Strong analytical and problem-solving skills with the ability to balance detailed execution and strategic oversight
Solid understanding of regulatory frameworks including FDA regulations, 21 CFR Part 211, EU GMP, and ICH Q10
Preferred
Familiarity with Smartsheet, Power BI, or similar PM tools
Company
Dexian
Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.
1001-5000 employees
H1B Sponsorship
Dexian has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (65)
Funding
Current Stage
Late StageLeadership Team
Mahfuz Ahmed
Chairman of the Board
Vikram Motiani
Managing Director, APAC
Recent News
2025-11-19
Company data provided by crunchbase