AT
Global Coordinator -PIPELINE
Aequor Technologies LLC
🇺🇸 United States
Hybrid
Manager or above
2 days ago
- GMP
- GxP
- Smartsheet
2 days ago
Job Description: Global Coordinator
Department: Manufacturing & Supply Chain (MSC) OperationsLocation: Princeton, NJ or San Diego, CA
Hybrid schedule
Position Summary
The Global Coordinator will support growing international footprint by coordinating operational activities required to register, launch, and sustain products in global markets outside the United States. This role will work closely with Manufacturing, Supply Chain, Quality, Regulatory, and other internal stakeholders to support ROW submissions, partner requests, compliance activities, and ongoing market maintenance.
The successful candidate will be highly organized, process-oriented, and capable of managing multiple concurrent activities across markets, partners, and regulatory frameworks. This position focuses on coordination, documentation management, process execution, issue resolution, and ensuring operational requests are efficiently coordinated through completion, while supporting activities within a regulated environment requiring familiarity with GMP, GxP, and quality system requirements.
Key Responsibilities
Global Expansion Coordination- Coordinate cross-functional activities supporting global submissions, launches, and post-launch market maintenance
- Collaborate for operational activities across Manufacturing, Supply Chain, Quality, Regulatory, and other internal partners as needed
- Track critical milestones, deliverables, risks, decisions, and dependencies across multiple markets
- Facilitate communication and alignment between internal stakeholders and external commercial partners
- Coordinate collection, maintenance, and distribution of operational and compliance documentation
- Manage recurring requests for market-specific documentation including CPPs, Certificates of Origin, GMP certificates, manufacturing declarations, quality documentation, and other submission support materials
- Identify document owners, approvers, and signature requirements
- Maintain organized repositories and standardized documentation packages to support reuse across markets
- Support development and continuous improvement of submission support tools, templates, and document libraries
- Apply working knowledge of GMP, GxP, and quality system requirements when coordinating documentation, compliance activities, and market-specific operational requests
- Coordinate annual compliance activities and recurring market requirements
- Monitor, track and coordinate implementation of post-approval changes via Acadia's quality management system (QMS) and assess impacts across multiple markets and partners
- Support artwork, packaging, labeling, and product configuration coordination
- Assist with knowledge transfer activities and readiness planning associated with new market entries
- Ensure ongoing visibility of operational requirements as products progress from submission through commercial supply
- Develop and maintain scalable processes that support increasing numbers of international markets
- Manage trackers, dashboards, and reporting tools for ROW activities
- Support development of Acadia's future global operating model and ROW support framework
- Maintain global market requirement databases and trackers
- Identify opportunities to automate, simplify, and standardize ROW processes
- Develop and implement systems and tools that improve coordination and visibility
- Develop reporting and metrics to support leadership decision-making
Qualifications
Education- Bachelor's degree in Manufacturing, Supply Chain, Life Sciences, Business, Operations, Engineering, or related discipline.
Experience
- 2-4 years of experience in pharmaceutical, biotechnology, medical device, or regulated industries.
- Experience coordinating cross-functional projects and stakeholders.
- Experience working with GxP documentation, electronic quality system (QMS), compliance, regulatory submissions, or operational processes.
- Global or international business experience preferred.
- Exceptional organization and project coordination skills.
- Strong attention to detail and follow-through.
- Ability to manage multiple priorities simultaneously.
- Excellent communication and stakeholder management skills.
- Comfortable working across time zones, cultures, and external partner organizations.
- Strong Microsoft Office, SharePoint, Smartsheet, and reporting tool proficiency.
- Experience using an e-QMS if preferred.
- Demonstrated ability to develop and improve operational processes.
Global Coordinator -PIPELINE · Aequor Technologies LLC