59 regulatory compliance internal audit jobs found in Bismarck

At Prime Therapeutics (Prime), we are a different kind of PBM, with a purpose beyond profits and a unique ability to connect care for those we serve. Looking for a purpose-driven career? Come build the future of pharmacy with us. Job Posting Title Client Audit Specialist - Remote Job Description As a member of the Client Audit Management (CAM) team, the Client Audit Specialist is accountable for independently, or in collaboration with senior staff or compliance leader, managing regulatory and/or client-initiated audits. The Specialist is responsible for evaluating and understanding the purpose of various audit types and the related deliverables, developing a holistic understanding of the audit management process, and managing the end-to-end audit activities. This position seeks and obtains additional expertise as indicated from respective Compliance and Operational subject matter experts to meet applicable regulatory, client, and/or functional audit expectations....

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Key Responsibilities Strategic & Solution Leadership Serve as the Solution Owner and functional expert for integrated systems, including SAP S/4HANA, SAP CGTO, Salesforce ATM, and Enterprise MDM. Define the architecture, solution design, and technical roadmap for critical GxP systems supporting Clinical Supply Chain, Commercial Operations, Quality Management, and Manufacturing. Lead the...

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Position Summary The Senior Manager (Source-to-Applications) will lead the solution, design, and delivery of the company's Source-to-Pay (S2P) technology ecosystem, encompassing Coupa, SAP as ERP, and related integration layers . This role is responsible for ensuring seamless process alignment between Procurement, Finance, and Supply Chain , optimizing technology investments, and enabling digital...

About Us SolomonEdwardsGroup, LLC ("SolomonEdwards") is a full-service professional services firm offering financial, operational, and technology consulting and operations support. We work with some of the world's most prominent companies to help them envision and achieve a better future. We know that our consulting services are only as meaningful as the people and talent behind them, and we are committed to recruiting incredibly talented, committed, and collaborative individuals who can help us deliver exceptional client service. For more information, visit SolomonEdwards Position Summary: We are seeking a Senior Technical Implementation Lead with deep expertise in Anti-Money Laundering (AML) and Fraud Transaction Monitoring Systems to design, implement, and optimize enterprise-scale monitoring solutions across our U.S. banking operations. This individual will play a key role in delivering technology solutions that strengthen our Client's financial crime detection...

Job Description Oracle's Global Physical Security (GPS) Systems Team is responsible for securing the corporation's global datacenter and facility footprint through advanced Physical Access and Identity Management (PIAM) technologies. We are seeking a seasoned Technical Program Manager (TPM) for Wireless Intrusion Detection Systems (WIDS) who will own the end-to-end lifecycle of enterprise wireless detection, monitoring, and counter-surveillance solutions for a complex and global security environment. Reporting to the Director, Physical Security Products & Services, you will lead the technical roadmap, policies, education, and integrations necessary for WIDS excellence-partnering closely with security operations, engineering, data center operations, and end-user groups. Responsibilities Product & Program Ownership Own the lifecycle management, standards, and feature evolution for all Wireless Intrusion Detection Systems (WIDS), including integration with...

The Associate Director will serve as a key member of the Learning Center of Excellence within Global Quality, responsible for designing, implementing, and sustaining high-impact training programs for Commercial and General & Administrative (G&A) functions. This role ensures that learning strategies align with regulatory requirements, corporate standards, and business objectives, fostering a culture of compliance, quality, and continuous improvement across global operations Key Responsibilities: Learning Strategy & Design Develop and execute a comprehensive training strategy for Commercial and G&A teams in alignment with Global Quality standards and business priorities. Partner with functional leaders to identify learning needs, compliance gaps, and performance improvement opportunities. Program Development & Delivery Design engaging, scalable, and compliant learning solutions (e.g., instructor-led, virtual, e-learning)...

Job Description Oracle Health Data Intelligence (HDI) is entering a critical phase of regulatory and security modernization across our global health analytics and AI-enabled population health platform. As HDI accelerates readiness for MDR (Medical Device Regulation), AI regulatory requirements, and emerging global security standards, we are expanding our Security Architecture team with specialists who bring deep technical expertise, cloud security experience, and strong regulatory awareness. We are hiring Security Architecture Specialists who can design, review, and validate secure architectures across cloud-native healthcare systems, AI/ML pipelines, and distributed data platforms. This role is ideal for someone with experience performing CSSAP-style reviews , cloud security assessments, threat modeling, and providing technical guidance that aligns engineering execution with security and regulatory expectations. You will play a key role in ensuring that HDI's...

The Associate Director, GxP Training, is a critical member of the Learning Center of Excellence within Global Quality. This role is responsible for developing and maintaining robust training programs that ensure compliance with Good Practice (GxP) regulations across the organization. The position will lead the design, implementation, and governance of global learning strategies that support regulatory readiness, operational excellence, and a strong quality culture. Key Responsibilities: Learning Strategy & Governance Define and execute the global GxP training strategy in alignment with regulatory requirements and corporate quality objectives. Establish governance frameworks for training compliance, including policies, procedures, and audit readiness. Program Development & Delivery Design and oversee GxP training programs for diverse functions (e.g., R&D, Manufacturing, Quality, Clinical, and Commercial). Develop innovative...

Job Description Job Summary: We are seeking a detail-oriented Compensation Analyst to join our team and support a wide range of global compensation compliance and data analysis activities. This role requires advanced Excel skills and the ability to analyze large data sets, identifying trends and potential risks based on the data. While experience with US compliance reporting is a plus, it is not required. The Compensation Analyst will collaborate closely with stakeholders across the organization to ensure compensation programs are administered effectively and meet regulatory requirements. Strong project management abilities and the ability to clearly communicate across all organizational levels are essential for success in this role. Responsibilities Key Responsibilities: Conduct and support data analyses related to compensation compliance and reporting requirements. Prepare regular and ad hoc reports to support global compensation programs....

Job Description Oracle's Global Physical Security (GPS) Systems Team is responsible for securing the corporation's global datacenter and facility footprint through advanced Physical Access and Identity Management (PIAM) technologies. We are seeking a seasoned Technical Program Manager - Video Management Systems. The Global Physical Security (GPS) Systems Team is responsible for deploying, maintaining, and continuously enhancing Oracle's physical security technology landscape. Oracle seeks a highly skilled Technical Program Manager (TPM) for Video Management Systems (VMS) who will own the end-to-end lifecycle of enterprise video systems, standards, and best practices for a complex and global security environment. Reporting to the Director, Physical Security Products & Services, you will lead the technical roadmap, policies, education, and integrations necessary for VMS excellence, partnering closely with security operations, integration partners, internal maintenance...

About Us SolomonEdwardsGroup, LLC ("SolomonEdwards") is a full-service professional services firm offering financial, operational, and technology consulting and operations support. We work with some of the world's most prominent companies to help them envision and achieve a better future. We know that our consulting services are only as meaningful as the people and talent behind them, and we are committed to recruiting incredibly talented, committed, and collaborative individuals who can help us deliver exceptional client service. For more information, visit SolomonEdwards Position Summary: We are seeking a Senior Manager / Director of Financial Reporting to join a leading, growth-oriented company in the financial services sector with operations across the U.S. This role will play a pivotal part in supporting key external reporting processes, SEC compliance, and financial oversight during a high-impact period. Essential Duties: · Lead preparation and review of...

Job Summary The Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight of clinical and commercial controlled substances manufactured at CMOs under contract by Otsuka. This role is responsible to ensure that clinical and commercial products that may be classified as controlled substances are manufactured, packed, labelled, stored, and transported accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. Job Description Responsible for directing quality oversight of GMP contract...

At Prime Therapeutics (Prime), we are a different kind of PBM, with a purpose beyond profits and a unique ability to connect care for those we serve. Looking for a purpose-driven career? Come build the future of pharmacy with us. Job Posting Title Sr. IT Risk & Controls Analyst - Contract Negotiations - Remote Job Description We are presenting a unique opportunity for an experienced IT Risk and Controls Analyst with a background in Contract Negotiations. As a Sr. IT Risk & Controls Analyst you would be responsible for leading the development and execution of processes and people to ensure IT compliance with regulatory, industry and client security requirements. This role is responsible for working with cross-functional teams and management to set direction and secure resources for the operational processes needed to support the Security Governance Risk and Compliance program. Responsibilities Lead the development, implementation and enforcement...

Job Description Oracle Health is transforming its development and regulatory processes to meet heightened FDA, MDR, and ISO 14155 standards and address ongoing patient safety, compliance, and product certification needs. As a clinical leader with patient safety and compliance expertise, you will provide organization-wide clinical leadership and strategic oversight, ensuring our product development teams integrate clinical context, manage patient safety risks, and maintain robust compliance across the entire portfolio-legacy and new. This role is essential in modernizing our clinical risk management and regulatory practices in partnership with AI-driven process improvements. Qualifications · Medical degree (MD, DO, or equivalent) required; board certification or clinical specialty training preferred. · Minimum 7 years' experience in clinical leadership roles within medical device, digital health, or regulated healthcare software sectors. · Extensive experience in...

Company : Highmark Inc. Job Description : JOB SUMMARY This job supervises and coordinates the day-to-day activities of the UM Intake Coordination team. The incumbent selects, develops and continuously coaches staff to the highest levels of performance. Motivates and team builds through the creation of a work environment and conditions that contribute to highest levels of performance. ESSENTIAL RESPONSIBILITIES Perform management responsibilities including, but limited to: involved in hiring and termination decisions, coaching and development, rewards and recognition, performance management and staff productivity.Plan, organize, staff, direct, and control the day-to-day operations of the department; develop and implement policies and programs as necessary; may have budgetary responsibility and authority. Determine workflow for the day and assign work to the team.Monitor and manage daily inventories to ensure adequate staffing and resources are...

Job Summary The Associate Director, Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and optimize global quality system processes across a global quality organization. This role is instrumental in ensuring that quality operations are efficient, compliant, and aligned with strategic business goals. Job Description Operational Excellence Lead continuous improvement initiatives across global quality to enhance efficiency, effectiveness, and compliance. Identify and implement best practices, metrics, and tools to drive performance and accountability. Facilitate cross-functional collaboration to streamline and optimize end-to-end workflows, as well as enhance overall operational alignment. Ensure effective change management strategies are applied to drive successful implementation and adoption of operational initiatives. Risk Management Develop and maintain a proactive...

Job Summary The Director, Nephrology & Immunology Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the Nephrology and Immunology therapeutic area. This role ensures the timely, accurate, and compliant communication of scientific and clinical data through congress abstracts, posters, manuscripts, and other peer-reviewed outputs. Serving as the functional lead for publication operations within the Nephrology & Immunology Medical Communications team, the Director partners closely with cross-functional stakeholders, including Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Medical Strategy, Core Content, and external vendors, ensuring excellence and consistency in scientific communication across the portfolio. The position reports to the Senior Director, Nephrology & Immunology Medical Communications Lead and plays a key...

The Senior Manager, Centers of Excellence (CoEs) is responsible for establishing, leading, and optimizing one or more prioritized CoEs within the Global Quality Operations organization-such as Inspection Readiness, Audit Effectiveness, or other strategic focus areas. This role drives execution of CoE initiatives, develops tools and frameworks, and delivers performance metrics and dashboards to support continuous improvement and operational excellence. The ideal candidate will have strong global collaboration skills and experience working across cross-functional teams in a matrixed environment. Key Responsibilities Centers of Excellence Leadership Lead the development and execution of one or more CoEs (e.g., Inspection Readiness, Audit Effectiveness) aligned with global quality priorities. Establish CoE charters, operating models, and governance structures to ensure clarity and accountability. Develop and maintain tools, templates, and guidance documents...

Job Summary The Associate Director, R&D HCP Engagement CoE is a critical change agent and system implementer responsible for designing the operating model and overseeing the execution of a unified, compliant, and exceptional service model for all Healthcare Professional (HCP) engagement and contracting within R&D. This role will seek to transform an inconsistent process into an audit-ready, "white glove" service, providing necessary direction to a direct report responsible for day-to-day execution. While initially focusing on Medical Affairs, the vision is to cover all R&D HCP engagement over time. This position reports into the Medical Excellence & Operations Vendor and Contracts Management Lead and directly manages the Manager, HCP Engagement Lead. This position will lead the transformation of how Otsuka plans, governs, and executes interactions with healthcare professionals; ensuring all engagements are conducted with the highest standards of integrity,...

The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. Key Responsibilities Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers. Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. Quality & Compliance:Serve as the quality and compliance lead for controlled...

The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's global network of contract manufacturing organizations (CMOs). This role supports the qualification, monitoring, and compliance of external manufacturing partners to ensure the quality and reliability of pharmaceutical products, including small molecules and biologics. Job Description Supplier Quality Execution Support the qualification and ongoing monitoring of CMOs and critical suppliers. Execute supplier audits and ensure timely follow-up and resolution of findings. Maintain and update quality agreements in collaboration with internal stakeholders. Conduct risk assessments and support mitigation plans for supplier-related quality issues. Compliance & Documentation Ensure supplier compliance with global regulatory requirements (e.g., FDA, EMA, ICH). Prepare...

Job Summary The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, supports audit and inspection readiness, and collaborates with internal teams and external partners to maintain high-quality standards throughout the clinical development lifecycle. Key Responsibilities Clinical Study Support Serve as a GCP quality resource to clinical teams during study planning, conduct, and close-out. Support the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance. Assist in identifying and resolving quality issues, protocol deviations, and potential noncompliance. Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices...

The Manager, Contracts (Non-HCP SOWs) is an important role within the Medical Excellence & Operations team within Global Medical Affairs. This role is responsible for end-to-end management of contracts that support Global Medical Affairs operations, excluding those with healthcare professionals or organizations. This includes agreements with vendors, consultants, technology platforms, contract research organizations (CROs), publication and medical education vendors, and other third-party service providers. This role will support the Global Medical Affairs team to ensure efficient operations, compliant contracting that align with global and regional regulations, Otsuka policies and GMA goals. This role reports directly into the Vendor Contracts and Management Lead who reports into the Executive Director, Medical Excellence and Operations. Job Description Key Responsibilities Include: Contract Development and Management Expertise Lead drafting, reviewing,...

The Global Quality Audit Manager is responsible for planning, executing, and reporting on global audits to ensure Good Clinical Practice (GCP) compliance across Contract Research Organizations (CROs), clinical laboratories, and clinical investigator sites. This role plays a critical part in maintaining the integrity of clinical trial data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards. As a key member of the Global Quality Management team, the Audit Manager will collaborate with cross-functional stakeholders to identify risks, drive continuous improvement, and support inspection readiness across the clinical research landscape. Key Responsibilities Audit Execution : Plan, conduct, and report GCP audits of CROs, clinical laboratories, and investigator sites globally, ensuring compliance with ICH-GCP, local regulations, and company policies. Provide oversight to contract and consultant resources in audit...