Change Control Owner â Biotech
Change Control Owner â Biotech
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Salary Not Disclosed
1 Vacancy
Job Description
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.
Required Qualifications
- Bachelors 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.
Preferred Qualifications
- Lean Six Sigma or similar process improvement certification.
- Experience supporting global or multi-site biotech operations.
Employment Type
Full-Time
