The Change Control Owner manages the Change Control process within a biotech environment, oversees change requests, ensures documentation compliance, and drives continuous improvement initiatives.
Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
We are seeking a highly motivated and detail-oriented Change Control Owner to oversee the end-to-end management of the Change Control process within a regulated biotech manufacturing environment.
Key Responsibilities- Serve as the process owner for the Change Control System within the Quality Management System (QMS).
- Lead and coordinate the evaluation, approval, execution, and closure of change requests across cross-functional departments (QA, QC, Manufacturing, Validation, Engineering, etc.).
- Ensure that all change controls are properly documented, risk-assessed, and supported with appropriate justifications and impact analyses.
- Maintain and improve Change Control KPIs (cycle time, on-time closure, overdue items, etc.) to meet quality and compliance objectives.
- Collaborate with internal audit teams and regulatory agencies during inspections, serving as SME for Change Control process.
- Drive continuous improvement initiatives related to change management and system efficiency.
- Bachelor’s degree in Life Sciences, Engineering, or related discipline.
- 3+ years of experience in a similar role within the biotech, pharmaceutical, or medical device industries.
- Proven experience managing or owning the Change Control process in a GMP-regulated environment.
- Experience with electronic Quality Management Systems (eQMS) such as TrackWise, Veeva, MasterControl, etc.
- Excellent organizational, communication, and problem-solving skills.
- Lean Six Sigma or similar process improvement certification.
- Experience supporting global or multi-site biotech operations.
Top Skills
Change Control
Electronic Quality Management Systems
Mastercontrol
Quality Management System
Trackwise
Veeva
Similar Jobs
Artificial Intelligence • Edtech • Machine Learning • Software
The Director of Operations and Customer Intelligence will enhance revenue operations through team leadership, AI integration, and strategic customer insights, driving product evolution and operational excellence.
Top Skills:
Ai DeploymentSaaS
Aerospace • Digital Media • Information Technology • Internet of Things • Mobile • Software
The Lead Coordinator will manage logistics, vendor relations, and maintenance contracts while also ensuring site security and compliance. They will handle scheduling, reports, and procurement and must possess strong organizational and communication skills.
Top Skills:
Ms Office Suite
Cloud • Healthtech • Payments • Professional Services • Software • Analytics • Automation
The Sr. Deal Desk Analyst will manage complex deals, provide sales training, improve processes, and ensure alignment between Sales and cross-functional teams.
Top Skills:
Conga CpqExcelSalesforce
What you need to know about the Boston Tech Scene
Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.
Key Facts About Boston Tech
- Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
- Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
- Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
- Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories
