BioLegend develops world-class, cutting-edge antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. Our mission is to accelerate research and discovery by providing the highest quality products at an outstanding value, along with superior customer service and technical support. Our product expertise covers a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. 

Job Summary

As BioLegend strives for continuous improvement and future growth, we seek an experienced, passionate, and dynamic Director to oversee all of Biolegend’s Quality Assurance functions. We are looking for someone who is organized, committed, and passionate about the job, and someone who possesses clear communication skills in all aspects.

In this role, you will have a hands-on role in defining, deploying, and leading organizational, process, and product quality requirements throughout the total product life cycle to fulfill the applicable global requirements. Your main functions will be to improve patient outcomes, meaningfully impact the company’s short-term and long-term success work closely with executives across the organization, play an active role in how this position contributes to the overall company strategy, learn about new innovative technologies, and utlilize BioLegend’s collaborative company culture to create an inspiring and productive workplace.

Essential Functions

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

• Responsible for Continuous Improvements of the BioLegend Quality Management System including: Management Review, Change and Document Control, Records Management, Audit and Inspection Management, Corrective and Preventive Action Management, Post-Market Surveillance Management (Complaints, Failure Analysis, MDR, Field Actions, etc.), Risk Management per total product life cycle, Nonconformance Management, Distribution Quality, Supplier Quality, and Manufacturing Quality
• Work collaboratively with Regulatory Affairs and Research and Development regarding Product Development (Design) Controls, Design Assurance, and Labeling Control
• Ensure effective implementation of Quality Management Systems and Compliance requirements across BioLegend
• Ensure that a highly effective and motivated Quality Assurance team is in place to meet the needs of the business, including staffing, training, performance management, and personnel development
• Interface with government authorities regarding Quality System and Compliance issues
• Monitor the activities of government regulatory authorities on a worldwide basis to ensure that the business is able to align with, comply with, and anticipate changes
• Guide manufacturing and design groups with Quality Systems and Compliance interpretation, establishment, and maintenance
• Develop a strong working relationship with internal partners to ensure compliance with regulatory requirements, and provide appropriate quality support across all business units
• Prepare, present, defend, and manage the Quality and Compliance departmental budget and staff
• Lead team for the due diligence and integration activities as needed
• Other duties as assigned

Competencies

• Accountability -Accepting responsibility that results in anticipation/prevention of problem areas from actions, and problem solving inside and outside the department/organization.
• Adaptability - Maintaining effectiveness in reaching set goals by adapting to changed circumstances, tasks, responsibilities, and people.
• Communication- Shaping and expressing ideas and information in an effective manner. Expressing ideas and opinions clearly in properly structured, well-organized, and grammatically correct reports or documents; utilizing language and terminology that is understandable for the reader.
• Leadership - Achieving results through people by successful objective setting, performance review, motivation, delegation, teambuilding, commitment gains, and empowerment.
• Planning and Organizing - Setting priorities and defining actions, time, and resources needed to achieve predefined goals.
• Teamwork - Working as a productive member of a cohesive group toward a common goal, and contributing to team development and effective team dynamics.