Amy Erickson Hagen

About Amy Erickson Hagen

Executive operations and compliance leader with 22+ years of experience in the fertility and reproductive health industry, spanning IVF, reproductive tissue banking, and multi-site laboratory operations. I specialize in solving complex operational, regulatory, and organizational challenges within highly regulated healthcare environments.In addition to leading multi-site laboratory operations, I have overseen national inventory management and lifecycle strategy for SmartSleeve products, ensuring alignment between supply chain operations, quality standards, and clinical partner needs. I also led the cross-functional team that developed Cryo-Logix, guiding the concept from operational need through design, implementation, and market readiness—bridging laboratory insight, regulatory requirements, and business execution.My strengths include strategic problem solving, quality systems leadership, operational execution, product development collaboration, and corporate partnership development. I am known for building strong, trust-based partnerships with clinic and healthcare stakeholders to align operational goals, improve efficiencies, and implement solutions that make day-to-day clinical work easier. I have worked directly with clinic partners to design and launch new service offerings that reduce burden, improve workflows, and support patient care.Throughout my career, I have led cross-functional teams of up to 21 staff across three offsite laboratories, with direct responsibility for operating budgets up to $1.2M, including forecasting, income statement analysis, year-to-date budget management, and cost control. I bring a disciplined approach to aligning people, processes, products, and partners to eliminate inefficiencies and sustain momentum.I am deeply experienced in quality management systems (QMS), regulatory compliance, audit readiness, risk management, SOP development, validation, training, continuous improvement, and change management. As a trusted advisor to executive leadership, I translate complex regulatory requirements into clear, actionable frameworks that drive accountability and execution across internal teams, product teams, and external partners.I thrive in fertility, reproductive medicine, life sciences, and healthcare operations environments where strategic problem solving, product innovation, corporate partnership development, regulatory leadership, and operational excellence can drive meaningful, scalable impact.

Experience

1. Vice President of Quality Assurance and Innovation

   REPROTECH®

   Jan 2019 — Present

   Lead cross-functional initiatives that drive compliance, quality, and operational excellence across the organization. My role spans oversight of the company’s Quality Management System, regulatory readiness, and strategic innovation projects that support long-term growth and risk reduction.I manage all quality assurance functions, including regulatory compliance, audit leadership, and the ongoing review and improvement of company processes. I ensure that systems and procedures align with applicable standards, regulations, and our internal quality objectives. I also lead investigations into systemic issues and oversee the evaluation of quality events.In my innovation capacity, I manage key program-based initiatives, including the implementation of new systems and equipment across sites, coordination with vendors, and the rollout of company-wide tools like Acumatica and tank monitoring systems. I work closely with the VP of Site Operations and site directors to ensure smooth execution of these initiatives.Key responsibilities include:Overseeing internal and external audits and communicating compliance risks to senior leadershipServing as the designated HIPAA Privacy OfficerLeading preparations for regulatory submissions and inspectionsEnsuring compliance with state licensing and professional accreditation requirementsSupporting business development efforts and client engagement, as neededAttending industry events and representing the organization externallyGuiding strategic project management and cost-effective implementation of company initiativesAssisting staff and management in system functionality, reporting, and vendor selectionFacilitating cross-department collaboration to improve staff and client safety, reduce risk, and maintain operational efficiencyThis dual role allows me to blend regulatory leadership with strategic innovation to support scalable, compliant, and forward-thinking growth across the organization.

Education

• North Dakota State University

  Bachelor of Science (B.S.), Animal & Range Science

  1995 — 1999

• Colorado State University

  Master of Science (M.S.), Physiology, General

  1999 — 2001

Skills

• Root Cause Analysis
• Risk Management
• Teaching
• Genetics
• Windows
• Marketing
• Life Sciences
• Public Speaking
• Laboratory Skills
• Outlook
• Microsoft Word
• Leadership
• Biotechnology
• Oncology
• Presentations
• Healthcare
• Research
• Client Development
• Quality Auditing
• Project Management
• Quality System
• Non-Profit Volunteering
• Fda
• Strategic Planning
• Corrective Actions
• Corporate Training
• Laboratory
• Microsoft Excel
• Powerpoint
• Procedure and Policy Development
• Special Projects
• Management
• Microsoft Office
• Customer Service
• Standards Compliance