Location: South Plainfield, New Jersey, United States of America
Provide leadership and direction to the QA team to ensure that the quality goals of the business units are being met. Own the Quality Management System and provide oversight to ensure compliance of said business units to company and quality requirements.
Plans, directs, and coordinates the efforts of Quality Assurance (QA) team members and QA activities towards maintaining an effective quality management system (QMS)
Works with senior management and leadership to set measurable business and team quality objectives, tracks performance against them and organizes management review of the QMS
Manages, maintains, and improves the QMS to achieve company quality objectives and meet the quality and regulatory standards needed by the business units,
Complies with and enforces established College of American Pathologists (CAP), Good Laboratory Practices, Good Manufacturing Practices, Good Clinical Practices, CLIA and Quality procedures and standards of operation.
Assists with implementation of quality system in global branches of BLSS and GENEWIZ.
Facilitate alignment of QMS and quality activities across departments to ensure adherence to BLSS/GENEWIZ quality standards and goal of meeting and exceeding customer requirements
Conducts regular internal facility and study audits to ensure compliance to our quality system and governing regulatory body requirements and coordinates external audits from clients or a third-party
Drive continuous improvement activities and CAPA program based on data from quality measuring and monitoring activities such as audit findings, customer feedback, deviations, non-conformance, etc.
Bachelor’s Degree in Life Science required
5 years of related work experience required
Minimum of 2 years managerial experience required
Ability to travel domestically up to 25%
Working knowledge of pertinent GLP/GCP/CLIA/CAP regulations, standards and guidance documents that dictate compliance qualifications.
Working knowledge of validation requirements
Ability to set priorities and adapt to changing business needs and manage multiple projects within established time frames.
Strong verbal and written communication skills are essential
Detail oriented with strong organizational skills
GENEWIZ is a leading global genomics service company and trusted provider for DNA sequencing, gene synthesis, molecular biology, next generation sequencing, bioinformatics, and GLP regulatory services. From the company’s founding, GENEWIZ has maintained its unwavering commitment to providing customers with the best value. Excelling in both science and customer support, GENEWIZ is dedicated to accelerating scientific discovery, as well as to developing and delivering innovative solutions for translational medicine and healthcare. Easily accessible around the world, GENEWIZ is the preferred partner at leading academic, pharmaceutical, biotechnology, agricultural, government, and clinical institutions. GENEWIZ employees have a winning attitude and champion innovation, teamwork and accountability through a results-oriented, customer-centric, and fun culture. We offer various health and financial benefits, learning opportunities, competitive compensation, rewarding bonus programs, and a wide range of work/life benefits designed to make your life easier.