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
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