Director of Global Quality Compliance

Company: Merz North America, Inc.
Location: Racine
Posted on: May 23, 2023

Job Description:

• Ensure Compliance of the Global Aesthetics Quality Management System(s) (QMS) to the most current version of applicable International Medical Product (Device, Rx, OTC, Biologic) Regulations and Standards through effective implementation, training, and monitoring.
• Establish and manage Global Internal and External Audit Programs including Interface with external agencies as required including the FDA and the Notified Body. -
• Partner with Global Regulatory Affairs to assure integration of Regulatory Intelligence activities and changing expectations into the QMS
• Develop company-wide Quality compliance roadmap and define priorities in line with global requirements and existing compliance gaps including the development, installation and monitoring of Global Quality Policies and Procedures
• Define global processes & collaborate with the site Quality Heads to ensure execution on site level, supporting the site leaders as needed
• Harmonize the quality compliance standards and ensure they are aligned across functions
• Collaborate with Global Site Quality Leaders to establish and execute digital strategies for Global Quality and Compliance DataMetrics & Data
  • Facilitate Global Quality Management Review for the Global Leadership Team (CEO, COO, CFO, CTO etc.)
  • Establish a global system for routine review of quality system data, including internal/external audit results to determine compliance gaps and associated mitigation plans on a global level
  • Define, implement and improve tracking mechanism for compliance progress
  • Allocates human resources and selects, acquires, and deploys appropriate methodologies to fulfill near term goals and commitments while ensuring sustainable quality performance.
  • Motivates and leads their organization to achieve business objectives.Budget
    • Manage Departmental Budgets in accordance with approved targets, work cross functionally to effectively support GTO budget objectives.Work from home eligibility: Management DiscretionThis job description is an overview intended to describe the general nature and level of work being performed by individuals assigned to this job. The descriptions above are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time. -This job description may be altered at any time during the course of employment with functions added, deleted and/or altered as necessary.Education
      • Higher Education (e.g. Bachelor's Degree) required
      • Master's degree in physical science or Business PreferredExperience -
        • 10 years minimum in the medical products industry required
        • 7 years minimum in a Quality function requiredKnowledge, skills and abilities (incl. languages)
          • Excellent written and oral communication skills with attention to detail required
          • Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines required
          • Ability to host, facilitate and execute audits with internal and external audiences required
          • Highly computer literate (Word, Excel PowerPoint), including formatting and getting documents submission-ready required
          • Fluent in English (required), Additional Language Proficiencies are an assetKnowledge of methods
            • Thorough understanding and knowledge of applicable regulations (ISO 13485, ISO 14971 and 21CFR Part 820 FDA regulations, MDSAP, MDD/MDR, and Canadian Medical Device Regulations (CMDR), etc.) - required
            • ASQ CQA, CQE, CQMOE - preferredPersonal skills
              • Ability to work effectively in a global, matrix environment required
              • Ability to work independently as well as direct and control the efforts of Direct Reports required
              • Strong interpersonal skills and ability to collaborate effectively with various technical area experts required
              • Comprehensive Medical, Dental, and Vision plans
              • 20 days of Paid Time Off
              • 15 paid holidays
              • 401(k)
              • And more!Your benefits and PTO start the date you're hired with no waiting period!
                Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Merz North America, Inc., Racine , Director of Global Quality Compliance, Executive , Racine, Wisconsin