Quality Operations Coordinator

Job Title: Global Operations Coordinator

Location: Princeton, NJ 08540 OR San Diego, CA 92130

Work Model: Hybrid, 60% onsite presence required

Duration: 12 months, with possible transition to FTE

Position Summary

The Global Operations Coordinator will support the growing international footprint by coordinating operational activities required to register, launch, and maintain products in global markets outside the United States (Rest of World/ROW). This role will support global submissions, product launches, operational readiness, compliance activities, and ongoing market maintenance.

The position requires strong cross-functional coordination, project management, documentation management, and process improvement skills within a regulated environment. The successful candidate will work closely with Manufacturing, Supply Chain, Quality, Regulatory, Packaging, and external commercial partners to manage multiple workstreams, track deliverables, resolve issues, and drive projects through completion.

Candidates should have experience in pharmaceutical, biotechnology, medical device, or other regulated industries, with working knowledge of GMP/GxP, quality systems, regulatory/compliance processes, and continuous improvement initiatives. Global or international business experience is preferred.

Education

• Bachelor's degree in Manufacturing, Supply Chain, Life Sciences, Business, Operations, Engineering, or a related discipline.

Qualifications

• 2-4 years of experience in pharmaceutical, biotechnology, medical device, or another regulated industry.
• Experience coordinating cross-functional projects, managing multiple workstreams, stakeholder communication, and driving operational activities through completion.
• Working knowledge of GMP/GxP, quality systems, regulatory/compliance processes, and regulated documentation.
• Practical exposure to QMS/eQMS, change control, document control, CAPA, deviations, audit readiness, or related quality processes.
• Experience managing project timelines, milestones, deliverables, risks, dependencies, and competing priorities.
• Demonstrated ability to develop or improve operational processes, workflows, trackers, dashboards, templates, and reporting tools.
• Proficiency in Microsoft Office, particularly Excel, and experience with project tracking and reporting tools.

Key Responsibilities

Global Operations and Project Coordination

• Coordinate cross-functional activities supporting global product submissions, launches, operational readiness, and post-launch market maintenance.
• Collaborate with Manufacturing, Supply Chain, Quality, Regulatory, Packaging, and external partners to align timelines, deliverables, and priorities.
• Manage multiple workstreams, track milestones, risks, dependencies, and issues, and drive projects through completion.
• Proactively resolve roadblocks, escalate risks, and ensure stakeholder accountability across markets and time zones.

Documentation and Compliance Support

• Coordinate operational, quality, and compliance documentation, including CPPs, Certificates of Origin, GMP certificates, manufacturing declarations, and submission support materials.
• Manage document owners, approvals, signatures, timelines, and standardized documentation repositories.
• Support GMP/GxP compliance, document control, audit readiness, and QMS activities in accordance with applicable quality requirements.

Operational Readiness and Market Maintenance

• Coordinate international market entries, product launches, annual compliance activities, and ongoing product lifecycle maintenance.
• Support post-approval changes, QMS change control, artwork, packaging, labeling, and product configuration activities.
• Assess operational impacts across markets and partners, coordinate knowledge transfer, and track readiness through approval and commercial supply.

Process Management and Continuous Improvement

• Develop and improve project trackers, dashboards, reporting tools, workflows, templates, and global market requirement databases.
• Track milestones, deliverables, risks, dependencies, and performance metrics to improve operational visibility.
• Identify process gaps and implement improvements to automate, simplify, standardize, and scale workflows.
• Drive continuous improvement and process ownership beyond routine task execution and tracker maintenance.

Preferred Qualifications

• Experience supporting global operations, international product launches, or Rest of World (ROW) market activities.
• Experience with global regulatory support, product commercialization, market-specific requirements, or post-approval changes.
• Experience using an electronic Quality Management System (eQMS).
• Proficiency in SharePoint, Smartsheet, Power BI, or similar project management, collaboration, and reporting tools.
• Experience developing dashboards, operational metrics, standardized templates, and scalable process improvements.
• Experience coordinating activities across Manufacturing, Supply Chain, Quality, Regulatory, Packaging, and external commercial partners.
• Familiarity with product lifecycle management, labeling, artwork, packaging changes, and ongoing market compliance.

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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.