Jobs
>
Fargo

    Audit Manager, Fargo ND - Danaher Corporation

    Danaher Corporation
    Danaher Corporation Fargo, United States

    2 weeks ago

    Default job background
    Description

    Audit Manager, Regulatory Affairs & Compliance

    At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

    Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

    This position is part of the Regulatory Affairs & Compliance department located in Fargo, ND and will be onsite with some travel (up to 10%). At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Regulatory Affairs & Compliance team and report to Regulatory Affairs & Compliance management responsible for planning, developing, and executing domestic and international regulatory compliance strategies related to statutory expectations and guidance documentation.

    In this role, you will have the opportunity to:

    • Manage and host client audits to ensure that client audit needs and expectations are met and that Aldevron is approved as a Supplier for both new and ongoing business.
    • Plan, lead, perform/host, and closeout client audits.
    • Present each audit observation to site leadership in recurring Review Boards.
    • Writes, assembles, reviews, and seek approval of audit responses by management before submitting to any client.
    • Track and trend audit observations and present to management on a continual basis.
    The essential requirements of the job include:
    • Bachelor's degree with 4 years of experience or Advanced degree (eg, MS, PhD, JD, MD) with 2 years of experience directly with Quality, Regulatory, Compliance, leading audits.
    • Demonstrated experience in customer interactions, project management, and presentation level communication skills.
    • Previous work experience within a CGMP or regulated environment.
    • Proven experience handling confrontations, negotiations in audit process.
    It would be a plus if you also possess previous experience in:
    • CGMP-compliant Contract Manufacturing Organizations in advanced therapies are preferred.
    • Experience with hosting and/or supporting regulatory inspections (FDA, MHRA, EMA, etc).
    • Qualified as an Quality/GXP Auditor by a third party.#LI-MR1
    At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

    Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

    The EEO posters are available here ) .

    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
  • Aldevron

    Audit Manager

    1 week ago

    Aldevron Fargo, United States Full time

    Audit Manager, Regulatory Affairs & Compliance · At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating env ...

  • Danaher Corporation

    Audit Manager

    1 week ago

    Danaher Corporation Fargo, United States

    Audit Manager, Regulatory Affairs & Compliance · At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating envi ...

  • Danaher

    Audit Manager, Fargo ND

    2 weeks ago

    Danaher Fargo, United States Full time

    Audit Manager, Regulatory Affairs & Compliance · At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating envi ...

  • Phoenix Industries

    Quality Management Officer

    2 weeks ago

    Phoenix Industries Dakota, MN, United States Freelance

    **With INNOVATION into the future**: · Soehnle Industrial Solutions is one of the leading European companies for professional measurement and weighing technology in the industrial and medical sectors. We develop, produce and distribute worldwide. In addition to our standard produ ...

  • Aurora Ventures

    Controller/Head of the Controlling Department

    1 week ago

    Aurora Ventures Cass City, United States

    About Group GmbH: · Our group is one of the fastest growing health-tech companies. · Our success is based on our team: We are not only the third largest online pharmacy in Germany, but also visionaries who look beyond the core business. · We are ambitious, push boundaries, and re ...

  • ZephyrTech

    Product Certifier

    1 week ago

    ZephyrTech Clay City, United States

    Your tasks: · Managing national and international approval and certification processes within development projects · Conducting conformity assessments · Developing normative requirements for products within project teams · Accompanying factory inspections/audits by testing facili ...

  • BlueSky Innovations

    Senior Model Validator

    1 week ago

    BlueSky Innovations Clay, United States

    My client is a state-owned commercial bank based in Frankfurt. They are currently looking for a Senior Model Validator. This is a hybrid role that allows you to work from home two days a week. The salary can go up to Euro per year, depending on experience. · Main responsibilities ...

  • Horizon Ventures

    Dual study program in Business Informatics with a focus on E-Government

    1 week ago

    Horizon Ventures Prairie Rose, United States

    Prairie Rose 'Oberfinanzdirektion Frankfurt am Main' is a part of the Hessian financial administration, where approximately employees work to collect and manage taxes. The money we collect is reinvested into education, security, economy, and social services. Working with us is an ...

  • Noridian Administrative Services

    Senior Provider Auditor

    1 week ago

    Noridian Administrative Services Fargo, United States

    * Position is eligible for Remote / Work from Home opportunity * · Department: Provider Audit · Job Grade: E12 · Notice of Collection & Privacy Policy for Applicants Residing in California: California Applicant Privacy Policy | Noridian ) · Job Title · Senior Provider Auditor · J ...

  • Noridian Administrative Services

    Senior Provider Auditor

    1 week ago

    Noridian Administrative Services Fargo, United States

    * Position is eligible for Remote / Work from Home opportunity * · Department: Provider Audit S-10 · Telecommuting Eligible: YES · Job Grade: E12 · Notice of Collection & Privacy Policy for Applicants Residing in California: California Applicant Privacy Policy | Noridian ) · Job ...

  • Ace Hardware

    Assistant Store Manager

    1 week ago

    Ace Hardware Fargo, United States

    Job Description · General Summary The Assistant Store Manager manages overall store operations and the achievement of company goals and directives. Essential Duties & Responsibilities Include the following. Other duties may be assigned. Customer Service · • Provide positive repr ...

  • MasTec Inc.

    Site Safety Coordinator or Specialist

    6 days ago

    MasTec Inc. Fargo, United States

    Overview · Responsible for assisting the Safety Managers in all job-site office related safety matters. Responsible for safety functions necessary to support Mastec Renewables at an assigned jobsite. Conduct site safety orientation, basic safety trainings, job safety analysis, wo ...

  • Blue Cross and Blue Shield Association

    Compliance Analyst

    1 week ago

    Blue Cross and Blue Shield Association Fargo, United States

    All about us · You likely know us as an insurance company, but that's just a portion of what we do. Hundreds of thousands of North Dakotans trust us to provide them with personalized service and unmatched access to care. It's a mission we take seriously. · We also work with entit ...

  • Tecta America Corporation

    Safety Coordinator

    1 week ago

    Tecta America Corporation Fargo, United States

    · Safety Coordinator · Position Identification: · Non-Exempt · Reports to: Director of HR and Safety · Position Summary: · The Safety Coordinator ensures compliance with all applicable Federal, State and local safety regulations governing the construction industry at the facilit ...

  • Jimmy John

    Shift Supervisor

    5 days ago

    Jimmy John Fargo, United States Full time

    Summary: Manages all function of the restaurant to ensure customer service and high quality products are delivered when the General Manager is not on duty. Responsible for the successful execution of fast, accurate sandwiches and world-class customer service while maintaining a c ...

  • CITY OF MOORHEAD

    Payroll Coordinator

    1 week ago

    CITY OF MOORHEAD Fargo, United States

    The City of Moorhead is accepting applications for a Payroll Coordinator in the Finance Division of the Administration Department. This skilled technical position performs intermediate work processing payroll, ensuring compliance with applicable laws, policies and contracts, veri ...

  • Spherion

    Manager of Accounting

    1 week ago

    Spherion Fargo, United States

    Spherion Staffing is interviewing experienced candidates for a Manager of Accounting role in Fargo. This position is responsible for overseeing and managing the financial accounting and reporting functions of an organization. This position ensures accurate and timely preparation ...

  • American Crystal Sugar

    Sr. Safety Specialist

    1 week ago

    American Crystal Sugar Moorhead, United States

    Starting salary at $99K (on-site) · We are looking for a motivated Sr. Safety Specialist to join our team at our Moorhead, MN factory. This individual will provide senior safety leadership to ensure the facility (including agriculture, operations and packaging/warehousing areas) ...

  • Danaher Corporation

    Shipping Coordinator

    1 week ago

    Danaher Corporation Fargo, United States Paid Work

    At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discov ...

  • Eide Bailly

    Audit Senior Associate

    1 week ago

    Eide Bailly Fargo, United States

    · Audit Senior Associate · Job Locations · US-ND-Fargo · ID · Category · Audit & Assurance · Position Type · Full-Time · Work Option(s) · Hybrid · Who We Are · Eide Bailly is one of the top 25 CPA and business advisory firms in the nation. We have over 40 offices in 15 states a ...