Sr. Manager, Quality Systems & Compliance

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 7000 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. Were 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.
• Accountable for Quality Systems governance document control training compliance internal audits supplier quality oversight CAPA governance management review inspection readiness quality met-rics and continuous improvement programs.

Key Accountabilities

• 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 compli-ance and business objectives.
• Partner cross-functionally to ensure lifecycle quality integration.

Networking/Key relationships

The purpose of the interactions with the listed departments is to promote quality Quality System Compliance and Inspection Readiness. This role interacts with the following departments:

• Manufacturing Operations
• Manufacturing Technical Support
• Laboratory Services
• Design & Sustaining Quality
• Regulatory Affairs
• Post-Market Surveillance
• Supply Chain
• Engineering

Minimum Knowledge & Experience required for the position:

• Bachelors degree in Engineering Life Sciences Quality Regulatory Affairs Business or related disci-pline.
• 8 years (Manager) or 10 years (Sr. Manager) in Quality Systems Compliance QA or Regulatory Affairs within a regulated environment.
• Leadership experience required

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

Travel requirements:
Travel is required less than 10% of the time.

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 individuals 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 for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.