Sr. Manager, Quality Systems & Compliance

Werfen•Norcross, GA

10d

About The Position

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. This role is responsible for leading and maintaining the Quality Systems & Compliance function for the Norcross Transfusion site. It 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. The position is accountable for Quality Systems governance, document control, training compliance, internal audits, supplier quality oversight, CAPA governance, management review, inspection readiness, quality metrics, and continuous improvement programs.

Requirements

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
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.

Nice To Haves

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

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.