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Sr. Manager, Quality Systems & Compliance

Werfen · Norcross, GA · Yesterday
Quality AssuranceFull-time

Overview

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

Responsible for leading and maintaining the Quality Systems & Compliance function for the Norcross Transfusion site. Provides strategic and operational leadership for the Quality Management System (QMS), ensuring sustainable compliance with applicable FDA Quality System Regulation (QMSR), ISO 13485, IVDR, MDSAP, and other global regulatory requirements.

Responsibilities

  • Own and maintain the site Quality Management System (QMS).
  • Lead Document Control, Internal Audit, Inspection Readiness, and Management Review programs.
  • Provide governance of Deviations, Nonconformances, CAPA, Change Control, and Risk Management.
  • Lead Supplier Quality governance and supplier audit activities.
  • Develop and report quality metrics and compliance indicators.
  • Drive continuous improvement initiatives utilizing Lean and Six Sigma methodologies.
  • Lead and develop a high-performing Quality Systems & Compliance team by fostering engagement, accountability, collaboration, and continuous professional development to achieve quality, compliance, and business objectives.
  • Partner cross-functionally to ensure lifecycle quality integration.

Qualifications

  • Minimum Knowledge & Experience required for the position:
  • Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Business, or related discipline.
  • 8+ years (Manager) or 10+ years (Sr. Manager) in Quality Systems, Compliance, QA, or Regulatory Affairs within a regulated environment.
  • Leadership experience required.

Skills & Capabilities

  • Expert knowledge of FDA QMSR, ISO 13485, IVDR, MDSAP, auditing, CAPA, and quality systems.
  • Strong leadership, coaching, communication, and project management skills.
  • Experience leading inspections and external audits.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

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