Manager, Quality Control

Introduction

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.

Overview

Job Summary

The Manager, Quality Control is a key contributor to the Quality Assurance and Regulatory Affairs (QARA) team for the Transplant Technology Center. Reporting to the Sr. Director Quality Assurance and Regulatory Affairs, this role will be responsible for leading the Quality Control team and all is responsible for all other aspects of the Quality Control Department.

Responsibilities

Key Accountabilities

• Leads the Quality Control (QC) team, providing strategic direction and day-to-day leadership, including setting clear, challenging, and achieveable SMART goals for the team, aligning individual and department goals with broader business unit strategy, prioritization of work, resource allocation, workforce planning and talent management, including hiring, onboarding, training, performance management to build a high performing team.
• Partners cross-functionally with Quality Assurance, Regulatory Affairs, Research & Development, Manufacturing Technical Support and Operations to resolve issues, support product development and ensure alignment.
• Ensures QC team team and site adherence to SOPs, FDA, Regulatory and Compliance (ISO 13485, 21 CFR 820, and MDSAP Requirements) and good manufacturing practices to ensure inspection readiness and audit compliance, while fostering a culture of accountability and quality excellence.
• Role models and reinforces company values, driving a high performance, collaborative, and inclusive team environment.
• Drives continuous process improvments and operational efficiency within the department, proactively identifying opportunities to enhance quality, scalability, and effectiveness across QC operations
• Participates in setting and adherence to the department budget. Coordinates the purchase, training and implementation of new equipment, products, and systems.
• Sets and tracks department key performance metrics and presents at QRB and MRB.
• Leads investigation governance within QC, with accountability for OOS, CAPA, and NCR investigations.
• Authors, updates and reviews SOPs, FORs and TMPs.
• Represents QC for Validaton Plans, Protocols and PDP projects.
• Oversees departmental planning and execution, including scheduling, planning, and prioritization of daily work and the QC Stability Program.
• Participates with technical support issues and coordinates QC resources for investigations.
• Reviews test results and coordinates QC resources with needed for investigations.
• Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

 

Networking/Key relationships

• Daily interaction with QC Team to support daily activities.
• Daily interaction with co-workers from Operations to ensure product release priorities.
• Interaction with Manufacturing Technical Support team in support of product investigations.
• Interaction with Research and Development to support new products and product improvements.
• Interaction with Quality Assurance for quality and regulatory compliance.
• Interaction with Customer Technical Support team in support of customer compaint investigation.

Qualifications

Minimum Knowledge & Experience required for the position:

• Bachelor’s Degree in Medical Technology or a Bachelor’s of Science Degree in a related field
• Minimum 10 years of clinical laboratory experience working with In-Vitro Diagnostics; preferred HLA screening Assay and Elisa products
• Minimum 5 years of people management experience; preferred people leadership in a clinical setting or GMP environment Strong analytical, communication, and leadership skills
• Demonstrated leadership skills
• Excellent