• Build and operationalize foundational global trade compliance processes, controls, and procedures. • Ensure compliance with international trade regulations, customs requirements, import/export controls, sanctions programs, and country-specific permitting requirements. • Partner closely with Supply Chain, Manufacturing, Regulatory Affairs, Quality, Clinical Operations, Logistics, Procurement, Finance, Legal, and Commercial teams. • Lead internal trade compliance reviews, investigations, and corrective action plans. • Develop and maintain the company’s global Harmonized Tariff Schedule (HTS) classification framework. • Coordinate and manage day-to-day Importer of Record (IOR) and Exporter of Record requirements globally. • Identify and administer duty drawback and duty optimization processes.

• Audit high risk reimbursement issues for both professional and facility billing across all of UW Health (Madison, Northern Illinois, and joint ventures). • Utilize in depth knowledge of CPT/ICD10 coding to assess, research, educate, and problem solve complex issues/questions. • Work with key stakeholders across the organization on projects and actively participate in meetings/workgroups. • Ability to be proficient in data analytics programs, systems, and databases to identify risks and track audit findings. • Responsible for compliance audits of billing providers and facilities

Role Description The Senior Insurance Product Compliance Professional negotiates with state and federal regulatory agencies to secure approval for insurance policies and certificates. This role supports the implementation and ongoing maintenance of compliant insurance policy and certificate documentation. It also contributes to departmental strategy and exercises sound judgment in determining how to manage technical work for complex project components. - Develop and maintain group policy and certificate language to support product initiatives, administrative practices, and applicable regulatory requirements. - Create awareness of current regulatory issues and ensure policy and certificate forms for the company's life, ancillary, and supplemental health insurance products remain compliant with applicable requirements. - Monitor and analyze regulatory requirements to assess insurance contract language impacts and provide consultative guidance to team members. - Develop and maintain self-funded group contract templates (Plan Management Agreement and Summary Plan Description) for assigned product(s). - Facilitate discussions with operational and compliance partners to review and finalize drafted contract language or assist with negotiating regulatory approvals. - Prepare standard policy and certificate forms for use as templates for state and federal regulatory filings and subsequent implementation. - Research and develop written responses or provide consultative support for regulatory objections, exams, and inquiries. - Maintain accurate and thorough documentation, including rationale for new or revised contract language, work instructions, and project tracking information. - Conduct quality reviews to ensure accuracy and compliance of generic and state-specific policy/certificate forms, advertisements, and other assigned materials. - Recommend and support process improvements to maximize efficiency. - Research and provide timely impact responses to Request for Proposals (RFPs) and/or Pre-sale Quotes (PSQs), draft, file and implement contract language to support client needs. - Serve as Subject Matter Expert (SME) for assigned product lines, responding to policy and certificate language questions, collaborating with cross-functional teams on regulatory impacts, and providing training and support to associates as needed. - Conduct and/or assist with research regarding contract language or competitor filings and provide findings (as assigned). Qualifications - Bachelor's Degree or equivalent experience in a healthcare/insurance compliance function. - Minimum 5 years of healthcare / insurance industry experience. - Knowledge of laws and regulations governing the healthcare / insurance industry, such as state Departments of Insurance and CMS. - Ability to research and analyze state laws and regulations. - Understanding of insurance products, including policy/certificate language. - Proficient in Adobe Acrobat and Microsoft 365 (Office) applications, including Word, Excel, Teams, and SharePoint. - Excellent oral and written communication skills, including the ability to collaborate effectively with associates across all levels of the organization and reviewer-level state/federal regulators. - Demonstrated attention to detail and accuracy. - Proven analytical and problem-solving ability. - Self-motivated and task-oriented, with an ability to manage multiple priorities and work under pressure to meet deadlines. Requirements - To ensure Home or Hybrid Home/Office employees’ ability to work effectively, the self-provided internet service must meet the following criteria: - At minimum, a download speed of 25 Mbps and an upload speed of 10 Mbps is required; wireless, wired cable or DSL connection is suggested. - Work from a dedicated space lacking ongoing interruptions to protect member PHI / HIPAA information. - Occasional travel to Humana's offices for training or meetings may be required. Benefits - Medical, dental, and vision benefits. - 401(k) retirement savings plan. - Time off (including paid time off, company and personal holidays, paid parental and caregiver leave). - Short-term and long-term disability. - Life insurance and many other opportunities. Scheduled Weekly Hours 40 Pay Range The compensation range below reflects a good faith estimate of starting base pay for full time (40 hours per week) employment at the time of posting. The pay range may be higher or lower based on geographic location and individual pay will vary based on demonstrated job-related skills, knowledge, experience, education, certifications, etc. $78,400 - $107,800 per year. This job is eligible for a bonus incentive plan based on company and/or individual performance.

Role Description We are seeking an experienced QMS and Digital Compliance Senior Director to lead transformational change within our quality compliance organization. This leadership role is responsible for driving the organization from its current state to a desired future state while maintaining and enhancing quality excellence throughout the transformation process. The role requires setting strategic direction, leading cross-functional partnerships, maturing the quality management system and digital compliance footprint to support commercialization and managing a high performing team of quality professionals. This role offers the opportunity to continue to grow and influence Intellia’s quality culture while leading a world-class team in a dynamic, innovative environment. Responsibilities: - Strategic Leadership & Transformation - Set overall strategic direction for the quality management system and digital compliance initiatives - Lead capacity planning for capabilities required to support growth strategies and pipeline expansion - Prepare the organization for future innovations and commercial product expansion - Play a leading role in Quality governance processes to support enterprise objectives - Quality Management System (QMS) Governance - Establish and maintain a comprehensive global QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company policies - Develop and implement GxP standards, procedures, and best practices across all modalities (cell and gene) and geographies - Provide strategic oversight for global quality systems including Management Review, Management Notification, Trending, Quality Planning & Continuous Improvement, Material Review Boards, Complaints and recall processes - Own Global Standards, Processes, Practices, Training programs, and implementation tools designed to meet regulatory, industry, and company expectations - Risk Management & Compliance - Develop and oversee risk-based approaches for quality system governance - Ensure proactive identification and mitigation of compliance risks - Monitor regulatory trends and implement proactive compliance measures - Serve as subject matter expert for inspection readiness and directly interact with Health Authorities during inspections - Draft responses to regulatory observations as needed - Performance Management & Analytics - Define common global effectiveness and efficiency metrics to drive end-to-end performance - Implement key performance indicators (KPIs) to monitor QMS effectiveness and enable data-driven decision-making - Generate and evaluate quality system health across all modalities, GxP areas, and geographies - Monitor performance metrics and provide insights to inform strategic decision-making - Drive continuous improvement initiatives leveraging data analytics and metrics - Technology & Systems Leadership - Act as leader and SME for supporting IT applications and analytical tools - Partner with IT and systems owners to ensure 21 CFR 11/Annex 11/GAMP 5 compliance for GxP computer systems lifecycle - Ensure systems are configured and maintained to support business needs and facilitate accurate reporting and analytics - Team Leadership & Collaboration - Develop, lead, mentor, and maintain a community of cross-functional subject matter experts - Foster collaboration on improvement initiatives and deepen organizational knowledge of processes and tools - Lead cross-functional teams to drive harmonization of governance processes - Foster a robust compliance mindset and culture of quality excellence throughout the organization - Manage product complaint handling activities team - External Engagement & Industry Leadership - Actively engage with external organizations and industry groups to monitor policy changes in regulatory environments - Represent the organization in industry forums related to quality management systems Qualifications - Deep knowledge of GxP regulations, QMS frameworks, and regulatory requirements across multiple modalities - Proven track record of leading organizational transformations - Strong analytical and strategic thinking capabilities - Experience with regulatory inspections and Health Authority interactions - Excellent leadership and cross-functional collaboration skills - Experience across multiple therapeutic modalities (small molecule, cell and gene therapy) - Global experience with various regulatory agencies (FDA, EMA, etc.) - Advanced knowledge of data analytics and performance management systems - BS, MS, or PhD in a field of science, engineering, pharmacy, or medicine - 15+ years of experience in the pharmaceutical industry with quality compliance leadership experience across research and development, commercial manufacturing, pharmacovigilance, information quality Requirements - Prolonged periods of sitting at a desk and working on a computer Benefits - Performance-based annual cash bonus - New hire equity grant - Eligibility for annual equity awards EEOC Statement Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.