Head of Laboratory Operations, Regulatory & Quality

SUMMARYThe Head of Laboratory Operations, Regulatory & Quality is responsible for establishing and maintaining all systems, processes and records required by CLIA regulations for a Commercial Test Laboratory. He or she is also responsible for maintaining FDA site registrations and processes required by a U.S. Initial Importer for approved IVD products and for supporting our client. The core responsibilities include the management of setup and qualification of all processes and systems supporting accurate and reliable patient testing. The Head of Lab Operations, Regulatory & Quality also participates in capacity planning, establishing quality systems, and generates periodic reports/metrics to ensure needs are being met in support of all laboratory operations.ESSENTIAL DUTIES AND RESPONSIBILITIESEstablish core systems including Facilities, Utilities, Services, Staffing and Operations required for Commercial Test Laboratories.Support planning and execution of U.S. product commercializationSupport Clinical Study agreements established for client.Submit applications and maintain compliance with all applicable regulations and regulatory agencies.Manage the resources to establish and maintain adequate status of compliance with CLIA laboratory registration, accreditations, and state regulations.Administer and manage the expenses related to the laboratory, including purchasing, invoices processing for payment to vendors, relationship with vendors and suppliers.Identify, select, implement, qualify, and maintain systems required by the laboratory, or which provide a higher degree of quality and/or compliance to laboratory operations (e.g., informatic technology, laboratory equipment, etc.)Coordinate efforts with laboratory personnel and Laboratory Director for preparation and hosting of audits by accreditation entities as well as customers.Participate and support of laboratory activities allowed by the knowledge, studies and/or licensed required, e.g., sample accessioning, documents and reports drafting and/or review, etc.Other duties as assigned.QUALIFICATIONSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Senior Management level experience operations and regulatory for IVD manufacturing, medical device manufacturing, or pharmaceutical operations – CLIA Lab experience preferred.Very strong analytical and problem-solving skills; organized and efficient.Proven interpersonal, communication, and presentation skills; excellent time management skills.Able to excel in collaborative, fast-paced, and evolving start up environment; able to manage competing priorities.Superb attention to detail; produces work of exceptional quality and accuracy.Ability to proactively identify issues and address with solutions-oriented approach.EDUCATION and/or EXPERIENCEPosition requires a Bachelor of Science degree, with senior level relevant industry experience. Experience with CLIA, ISO and U.S. FDA regulations is required. Strong leadership and project management skills are required. Demonstrated collaboration, negotiation and conflict resolution skills are required. Computer skills competency including Excel, Word and PowerPoint programs is necessary.LANGUAGE SKILLSAbility to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write complex reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from staff. Ability to develop and maintain effective working relationships at all levels. Ability to effectively present information to management and regulatory agencies as a qualified company representative. Ability to defend the lab structure and performance against corresponding regulatory expectations to management.MATHEMATICAL SKILLSAbility to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.REASONING ABILITYAbility to solve practical problems and deal with a variety of concrete variables in situations where general standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to understand and comply with all applicable regulations and guidelines. Ability to interpret a variety of technical instructions in mathematical or diagram form with concrete variables. Ability to identify strategies to address complex material quality issues.PHYSICAL DEMANDSThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to oversee or feel; and reach with hands and arms. The employee must frequently lift and/or move up to 40 pounds. May be required to wear Personal Protective Equipment for laboratory, temperature, humidity, and particulate controlled environments. Specific vision abilities required by this job include close vision, color vision, distance vision, and ability to adjust focus. Occasional air and ground travel may be expected.WORK ENVIRONMENTThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals, and extreme cold.The noise level in the work environment is usually moderate with background sounds from instruments and equipment in the laboratory. Noise level at other sites during audits may fluctuate.The statements herein are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.