Manager Quality Assurance- Genomic Services
Location: South Plainfield, New Jersey, United States of America
The Manager, Quality Assurance provides leadership and direction to the Quality Assurance team to ensure that the regulatory needs and quality goals of the business are being met. Our ideal candidate must have demonstrated exceptional leadership skills as well as solid regulatory experience. This role provides an ambitious individual opportunity to shape a true culture of quality through peer involvement and employee ownership as well as contribute to the growth of the company by increasing customer trust and satisfaction.
- 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.
- Responsible and accountable for all activities and outcomes related to regulatory portions of CAP, GxP and Compliance audits.
- Assists with implementation of quality system in global branches of Brooks Life Science (BLS) Services.
- Facilitate alignment of QMS and quality activities across company locations and departments to ensure adherence to Genomic Services quality standards and goal of meeting and exceeding customer requirements
- Oversees the review, approval, update, and maintenance of all SOP’s and other QA documents
- 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
- Performs QA review and approval for all regulatory documents and maintains archives of all regulatory projects
- 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.
Qualified candidates will have successfully completed a Bachelor’s degree in a Life Science field with at least 8 years in progressive Quality roles which includes at least 5 years managerial experience. Work related experience will include working knowledge of pertinent GMP/ GLP/ GCP/ CLIA/ CAP regulations, standards and guidance documents that dictate compliance qualifications. Candidates will be requested to provide demonstrated ability to manage multiple projects; setting appropriate priorities and meeting established timelines. The position requires advanced knowledge of Quality Management System(s) and proficiency in Microsoft Office Suite. Travel is rated occasional (up to 25%).