Data Integrity - GMP Compliance - Operations Readiness
Are you a proactive coordinator with a knack for structure, compliance, and cross-functional teamwork? This role could be your next big move.
We’re seeking a Project Coordinator to support a high-impact business transformation program in pharmaceutical operations. Your mission: to lead the operational readiness process, support change control, and help ensure data integrity in a GMP-regulated environment.
What You’ll Do
* Support project managers in driving site readiness for manufacturing transformation.
* Draft, track, and manage Change Controls in partnership with Quality teams.
* Facilitate Data Integrity Risk Assessments (DIRA) with cross-functional stakeholders.
* Coordinate and lead project meetings, track deliverables, and flag issues early.
* Ensure regulatory compliance through quality documentation and ALCOA+ principles.
* Work across departments to turn complexity into clarity and action.
What You Bring
* Degree in Science or Engineering (or equivalent experience).
* 7+ years in pharma operations or manufacturing projects.
* At least 4 years of experience in project coordination, ideally in regulated environments.
* Strong grasp of GMP, change control systems, and risk management.
* Critical thinker, strong communicator, and skilled facilitator.
* Fluent in MS Project, Excel, and cross-functional collaboration.
Bonus: PMP certification or experience with new manufacturing site creation.
Location: On-site project coordination (flexibility depending on phase)
Ready to step into a role that blends structure with transformation? Let’s talk.
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