Manager, Quality Control

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

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.

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 (ISOCFR 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.

Minimum Knowledge & Experience required for the position:

• Bachelors Degree in Medical Technology or a Bachelors 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 verbal and written communication skills
• Exhibits a disciplined approach to work ensuring thoroughness consistency validation and accuracy in all tasks and work product
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Effective communication
• Strong leadership
• Proactive problem-solving
• Stategic thinking
• Organizational skills and time management
• Coaching skills for improvement and problem solving
• Continous learning and development mindset
• Conflict resolution
• Foster a positive and inclusive work environment

Travel requirements:
Up to 5% annually.

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.