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.