Global LIMS Project Manager

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

The Global LIMS Project Manager leads the implementation, development, validation, deployment, training, and continuous improvement of the company’s global Laboratory Information Management System (LIMS) platform. 

 

This role manages a multi-year digital transformation project supporting non-clinical laboratory operations for the medical device, pharmaceutical, biotechnology, and combination product industries. It serves as the central project leadership role for coordinating global workstreams, managing dependencies, driving execution, and aligning laboratory operations, quality assurance, regulatory compliance, information technology, scientific leadership, commercial functions, and site leadership teams. 

 

The Global LIMS Project Manager partners with regional and functional project managers, business process owners, laboratory SMEs, quality and validation teams, developers, and external vendors to deliver successful adoption across global laboratory locations. 

 

Key Responsibilities 

Global Project Leadership 

• Lead the global LIMS transformation project across regions and laboratory sites.

• Build and maintain an integrated master plan covering workstreams, deployments, and strategic initiatives.

• Coordinate project leaders for development, deployment, validation, integrations, training, and operational readiness.

• Drive milestone execution and proactively manage risks to timeline, cost, quality, and compliance.

• Establish governance, executive reporting, and project performance metrics.

LIMS Development & Implementation 

• Coordinate system development, configuration, validation, enhancements, and releases.

• Partner with business analysts, developers, and laboratory stakeholders to align requirements with operations and client needs.

• Oversee implementation of laboratory workflows, sample lifecycle management, reporting, automation, and digital lab processes.

• Coordinate release planning and global site deployment schedules.

Systems Integration 

• Manage the plan to integration efforts between LIMS and enterprise platforms, including:

• CRM systems

• ERP systems

• Quality Management Systems (QMS)

• Document Management Systems

• Instrument interfaces

• Reporting and business intelligence platforms

• Align technical and business stakeholders to deliver integrations successfully.

Validation & Regulatory Compliance 

• Ensure project activities comply with applicable regulations, standards, and company procedures.

• Partner with Quality Assurance and Validation teams to support:

• Computerized System Validation (CSV)

• GAMP 5 methodologies

• Data Integrity requirements

• Electronic records and electronic signatures requirements

• Laboratory quality system requirements

• Ensure validation deliverables, documentation, testing, and approvals are completed on schedule and in accordance with procedures.

Laboratory Deployment & Operational Readiness 

• Lead deployment planning and implementation across laboratory locations.

• Coordinate readiness assessments, cutover planning, go-live support, and stabilization.

• Partner with Operations leaders to limit disruption to client testing services and laboratory throughput.

• Manage post-deployment support and transition to steady-state operations.

Training & Change Management 

• Coordinate the development and execution of training and adoption strategies.

• Integrate timelines for training materials, SOP updates, and work instructions.

• Partner with site leaders and SMEs to drive user adoption.

• Track organizational readiness and change management effectiveness.

Stakeholder & Client Impact Management 

• Partner with Operations, Scientific Affairs, Quality, Regulatory, Sales, and Client Services leaders.

• Facilitate clear communication across global and regional teams.

• Assess operational and customer impacts from system changes and deployments.

• Present project updates, risks, and recommendations to senior leadership.

Risk & Resource Management 

• Manage project budgets, resources, and forecasts.

• Maintain risk registers and dependency trackers.

• Escalate critical issues and resource constraints promptly.

• Resolve cross-functional challenges proactively.

 

Qualifications 

Education 

• Bachelor’s degree in engineering, Information Technology, Computer Science, Life Sciences, Business, or a related field.

• PMP certification is strongly preferred.

• Agile, Scrum, PRINCE2, or equivalent certification preferred.

Experience 

• 8+ years of project or project management experience.

• 5+ years leading enterprise software implementations.

• Experience in regulated medical device, pharmaceutical, biotechnology, CRO, CDMO, or contract testing environments.

• Experience coordinating large-scale software deployments across sites or regions.

• Experience leading cross-functional teams through influence rather than direct authority.

Preferred Experience 

• Laboratory Information Management System (LIMS) implementation or optimization.

• Contract testing laboratory operations.

• Medical device testing operations.

• Pharmaceutical quality or microbiology laboratory operations.

• Microbiological, Chemistry, and Physical testing environments.

• Computerized System Validation (CSV).

• GAMP 5 methodology.

• FDA, ISO 13485, ISO 17025, GMP, GLP, and 21 CFR Part 11 regulated environments.

 

Competencies 

• Project leadership

• Executive communication

• Regulatory compliance awareness

• Risk management

• Change management

• Stakeholder influence

• Strategic planning

• Cross-functional leadership

• Vendor management

• Process improvement

• Analytical problem solving

• Global collaboration

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.