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.
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.
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
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.
Minimum Qualifications - Education and Experience
Bachelor of Science degree in engineering or a scientific discipline
A minimum of 12 years of related experience in the medical device and/or diagnostics industry
6 years of people management experience
High energy, results-oriented leader with excellent collaboration and eQMS experience
Ability to utilize sound judgment and decision-making capabilities in technical, business, and regulatory compliance arenas
Strong expertise in domestic and international regulatory compliance requirements (e.g. FDA QSR, ISO/EN standards, and MDSAP)
Possess a deep Quality Engineering toolbox including Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Design for Six Sigma, Industrial Statistical Methods, Six Sigma and/or Lean Manufacturing
Experience leading internal audit programs and managing external inspections/audits (e.g. FDA, Competent Authorities, Notified Bodies)
Experience dealing with government regulatory bodies, Competent Authorities, and Notified Bodies
Ability to effectively interface with stakeholders internally and externally
Preferred Qualifications – Education and Experience
Master of Science degree in Business, Engineering, or a related scientific or technical discipline
Lean, Six Sigma, or Kaizen experience
Certified Quality Auditor or equivalent
Experience moving from a paper-based eQMS system to an electronic-based system
Familiarity with global quality management systems and regulatory requirements
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. BioLegend's reagents are supported by superior customer service and a quality management system that is certified for ISO 13485:2003. Our aggressive product development program, through technology licensing, collaborations, and internal hybridoma development, produces strategic reagents for use in a variety of applications including:
Flow cytometry and mass cytometry
ELISA and ELISPOT
Immunoprecipitation and ChIP
In vitro or in vivo functional assays.
BioLegend offers the broadest selection of fluorochrome conjugates for multi-color flow cytometry. With an experienced biochemistry team, BioLegend is well position...ed to offer a wide range of custom conjugation services to meet our customers' specific needs.
Our commitment to the research community is reflected in generous sponsorships of societies and meetings world-wide, our monthly travel award for junior investigators, and excellent bulk pricing. With iPhone/iPad apps, web tools, beautifully detailed posters, and new reagents, we look forward to bringing more creative innovation to make your research legendary.