Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a Project Manager - Operational Assessment to support a global clinical trial supply and fulfillment operation in West Chester, OH.

Position Overview

We are seeking a strategic and execution-focused leader to drive a phased operational transformation program supporting the evolution of a high-volume clinical trial fulfillment, operation. This role will establish a scalable operational and systems foundation, optimize workflows, and enable significant throughput growth while maintaining regulatory compliance.

The Project Manager will lead cross-functional alignment, systems optimization, Lean process redesign, and facility workflow improvements to support a targeted 15–20% increase in daily throughput and long-term scalable growth.

Key Responsibilities

Operational Assessment & Strategy

• Lead comprehensive assessments of current-state operations across fulfillment, inventory management, quality control, shipping, and supporting functions
• Facilitate cross-functional stakeholder workshops to identify inefficiencies, risks, and growth constraints
• Translate business objectives into actionable operational and systems strategies

Systems Evaluation & URS Development

• Lead evaluation of ERP and WMS platforms, including functionality, integration, data integrity, and scalability
• Develop and finalize the User Requirements Specification (URS) aligned to operational, technical, and regulatory requirements
• Identify system configuration opportunities and assess existing module capabilities
• Conduct gap analyses and define future-state system architecture
• Align system capabilities with redesigned operational workflows

Workflow Redesign & Lean Operational Optimization

• Lead detailed current-state process mapping across core operational workflows, including:
  • Restocking and replenishment strategies
  • Product location and storage methodologies
  • Kit ticketing and Bill of Materials workflows
  • Resource deployment models
  • Picking, labeling, and quality control processes
  • Order consolidation, staging, and shipping workflows
• Evaluate existing quality control processes, including full-kit verification practices, and design a risk-based QC strategy incorporating:
  • Barcode validation and system-driven verification
  • Error-proofing (poka-yoke) techniques
  • Statistical sampling methodologies where appropriate
• Perform value stream mapping to identify and eliminate non-value-added activities
• Redesign workflows to improve throughput, reduce double handling, and enhance labor efficiency
• Optimize order consolidation, staging, and shipping handoffs, including carrier integration
• Evaluate and improve warehouse layout and infrastructure to support:
  • Efficient product flow
  • Organized and scalable storage
  • Workforce productivity
  • Regulatory compliance
• Develop future-state operational workflows aligned with ERP/WMS capabilities and system roadmap
• Deploy Lean and Six Sigma methodologies to drive continuous improvement and sustainable performance gains
• Establish visual management systems and standardized work practices across fulfillment operations

Transformation Roadmap & Execution

• Develop and execute a prioritized operational and systems transformation roadmap
• Implement system enhancements, integrations, and workflow improvements aligned to throughput objectives
• Partner with IT, Quality, Engineering, and Operations to deliver integrated solutions

Performance Management & Analytics

• Define and implement key performance indicators (KPIs) tied to throughput, labor productivity, inventory accuracy, and quality
• Develop dashboard frameworks to provide real-time operational visibility
• Build throughput improvement models aligned to 15–20% performance targets
• Use data-driven insights to guide decision-making and continuous improvement

Process Governance, SOPs & Compliance

• Establish a scalable SOP framework aligned with optimized workflows and system controls
• Ensure all processes maintain compliance with regulatory requirements (e.g., FDA, GxP)
• Strengthen audit readiness, data integrity, and traceability across operations

Training & Change Management

• Develop and implement role-based training programs aligned with new systems and processes
• Lead change management initiatives to ensure adoption and sustainability
• Partner with HR and site leadership to build long-term organizational capability

Qualifications

• Bachelor’s degree required; advanced degree preferred (Engineering, Supply Chain, Life Sciences, or related field).
• 10+ years of experience in operations, supply chain, or manufacturing within life sciences or regulated environments.
• Proven experience leading large-scale operational transformation, warehouse optimization, or systems implementation initiatives.
• Deep expertise in ERP and WMS systems within regulated environments.
• Strong knowledge of Lean, Six Sigma, and process optimization methodologies.
• Demonstrated experience in URS development, gap analysis, and system/process integration.
• Strong understanding of GxP, FDA, and global regulatory expectations.

Key Competencies

• Strategic leadership with hands-on execution capability
• Deep operational and systems thinking
• Expertise in workflow redesign and facility optimization
• Data-driven decision-making and performance management
• Cross-functional influence and stakeholder alignment
• Continuous improvement and problem-solving mindset

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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