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
Fintech
Manage member satisfaction and retention by overseeing customer service operations and leading a team to improve service delivery and efficiency.
Top Skills:
ExcelMicrosoft OutlookMicrosoft WordSalesforce CRM
Artificial Intelligence • Cloud • HR Tech • Information Technology • Productivity • Software • Automation
The Head of Risk and Compliance will lead the market strategy for Financial Services, focusing on growth, customer engagement, and partnerships while driving revenue through industry expertise.
Top Skills:
ExcelMs Powerpoint
Artificial Intelligence • Cloud • HR Tech • Information Technology • Productivity • Software • Automation
Lead pricing strategies by developing monetization strategies, managing stakeholder alignment, and operationalizing pricing models across product management and marketing.
Top Skills:
AnalyticsData-Driven Insights
What you need to know about the Colorado Tech Scene
With a business-friendly climate and research universities like CU Boulder and Colorado State, Colorado has made a name for itself as a startup ecosystem. The state boasts a skilled workforce and high quality of life thanks to its affordable housing, vibrant cultural scene and unparalleled opportunities for outdoor recreation. Colorado is also home to the National Renewable Energy Laboratory, helping cement its status as a hub for renewable energy innovation.
Key Facts About Colorado Tech
- Number of Tech Workers: 260,000; 8.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lockheed Martin, Century Link, Comcast, BAE Systems, Level 3
- Key Industries: Software, artificial intelligence, aerospace, e-commerce, fintech, healthtech
- Funding Landscape: $4.9 billion in VC funding in 2024 (Pitchbook)
- Notable Investors: Access Venture Partners, Ridgeline Ventures, Techstars, Blackhorn Ventures
- Research Centers and Universities: Colorado School of Mines, University of Colorado Boulder, University of Denver, Colorado State University, Mesa Laboratory, Space Science Institute, National Center for Atmospheric Research, National Renewable Energy Laboratory, Gottlieb Institute
