Director of Global Quality Systems

About UsFounded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.A Brief OverviewAccountable for the development, execution and delivery of global quality systems strategies for Merz Aesthetics. Partner with Quality Site Heads, Global Quality Functions, R&D, Supply Chain, Operations & Marketing to assure Global Quality Objectives are identified and fulfilled. Drive continuous improvement in the overall quality systems infrastructure for Merz Aesthetics sites. 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.What You Will DoGlobal Quality System Infrastructure Owner of eQMS Software System(s) and their design, installation, qualification and deployment to Merz Aesthetics Global Manufacturing Sites and Affiliates. Develop company-wide Quality Systems roadmap and define priorities in line with global stakeholder needs and requirements. Owner of Quality Master Data Strategy and Execution into applicable systems (SAP, MES, eQMS, etc.)Evaluate and implement new technologies Evaluate and implement new technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed. Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.Global Alignment & Strategy Define global quality system processes & collaborate with the site Quality Heads to ensure execution on site level, supporting the site leaders as needed. Collaborate with Global Site Quality Leaders to establish and execute digital strategies for Global Quality and Compliance DataInspections and Audits QMS Subject Matter Expert for regulatory inspections and audits.Personnel Management 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 targets.Minimum RequirementsBachelor's Degree10+ years Minimum in the medical products industryPreferred QualificationsMaster's Degree7+ years in a Quality functionTechnical & Functional SkillsAbility to host, facilitate and execute audits with internal and external audiences.Highly computer literate (Word, Excel PowerPoint), including formatting and getting documents submission-ready.Fluent in English, Additional Language Proficiencies are an asset.Proficient in eQMS design and implementation, ability to collaborate closely with internal and external IT/OT partners.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.).Lean / Six Sigma Green Belt.ASQ CQA, CQE, CQMOE.Ability to work effectively in a global, matrix environment.Ability to work independently as well as direct and control the efforts of Direct Reports.Strong interpersonal skills and ability to collaborate effectively with various technical area experts.Benefits:Comprehensive Medical, Dental, and Vision plans20 days of Paid Time Off15 paid holidaysPaid Sick LeavePaid Parental Leave401(k)Employee bonusesAnd moreYour benefits and PTO start the date you're hired with no waiting periodEqual Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr