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Quality Assurance Manager

Company: Evolution Research Group
Location: Hialeah
Posted on: January 13, 2021

Job Description:

At Evolution Research Group our strength is in our people and our deep bench of specialized expertise in more than 50 specific indications for clinical trials. We're proud to set a high standard of success in our industry. To help us continue our mission to provide the highest quality clinical trial execution to help sponsors speed life-saving and life-enhancing therapeutics to market as quickly and safely as possible, we're seeking an experienced business manager to join our team. As an ideal candidate, you have proven experience in a highly dynamic setting. Your organizational, communication, and follow through skills are top notch and you enjoy continuous process improvement. You'll work closely with the VP of Quality Assurance and Site Director to evaluate ensure that all study-related procedures are completed properly from a clinical and a regulatory perspectiveThe role of the Director of Quality Assurance at CPMI is to ensure that all clinical trials are conducted in accordance with study protocols, FDA regulations, and ICH/GCP guidelines by way of internal audits, oversight of training, and the maintenance of all Quality driven activities at the clinic. This position is also part of the Quality Mobile Unit (QMU) which requires assistance and support of the overall Quality Management System for ERG to promote quality assurance, quality control, compliance, and auditing activities as they relate to conduct of studies or vendor management. As needed or in the absence of the Vice President of QA, lead the Quality Mobile Unit (QMU) team in plan, execution, and analysis of Quality Assurance initiatives as well as external audits for the organization, with direct report to the Vice President, QA. In executing these position responsibilities, the Director, Quality Assurance is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.Primary role to oversee and train Quality Control personnel at applicable portfolio Clinical Pharmacology Units under ERG. Ensure that all clinical trials are conducted in accordance with study protocols, FDA regulations, and ICH/GCP guidelines. Assists and supports the overall Quality Management System to promote quality assurance, quality control, compliance, and auditing activities as they relate to conduct of studies or vendor management. As needed or in the absence of the Vice President, Quality Assurance, lead the Quality Mobile Unit (QMU) team in plan, execution, and analysis of Quality Control initiatives as well as external audits for the organization, with direct report to the Vice President, Quality Assurance. In executing these position responsibilities, the Manager of Quality is guided FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.Objectives of this RoleManagement of Quality Control Personnel* Coordinates and oversees implementation of the company Quality Assurance and Quality Control Programs and serves as the functional lead for applicable QC personnel.* Assists in the development and maintenance of the QC program to achieve Operational Excellence under the guidance of the Vice President, Quality Assurance* Work with Site Directors and Quality Control personnel to identify challenging protocols, provide guidance and propose alternative solutions as applicable* Ensures that all applicable Quality Control personnel are adequately trained and adhere to Standard Operating Procedures and working guidelines while performing quality control tasks on assigned studies.* Effectively communicate with Operations regarding QC needs and program implementationQuality Management* Member of a professional team focused on clinical quality assurance/quality control and compliance-related activities in support of clinical programs and activities.* Assist in maintaining ERGs Quality Management System (QMS) to ensure compliance to Good Clinical Practice (GCP) and that the QMS is aligned with the internal policies and standard operating procedures for ERG.* Assist, if needed, in audit activities in the areas of Vendor Audit Management, facilitation of internal & external clinical quality audits, and agency inspections* Responsible for overseeing Corrective and Preventive Actions (CAPA) implementation and assist in conducting Quality reviews.* Perform any other tasks/duties as assigned* Drives QUALITY culture in support of enhanced organizational performance.* Travel to applicable region/ sites to assist with QC initiatives, evaluation of Corrective Actions, training of staff, study preparations, or sponsor meetings* Solid communication and collaboration with VP Quality Assurance and Site leadership team members to communicate risk, trends, or lessons learned to ensure corporate wide information sharing and knowledge exchange* Attends educational workshops where applicable* Stays informed and knowledgeable on all applicable regulations and guidelinesKnowledge, Education, and Experience* Understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR) as they apply to clinical research with at least 5 years of experience* Bachelor's Degree in a related field, or enough previous experience in clinical research required* Able to communicate with clients, sponsors, vendors, co-workers, and others in a collaborative and courteous manner.* Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change.Skills and Qualifications* Ability to work independently and as a team player* Ability to organize and prioritize within a changing environment* Uses safety/universal precautions to protect self, subjects, and staff* Able to appropriately advise and assist with guidance and regulatory requirements throughout study conduct* Strong organizational skills* Excellent documentation practices* Attentive to detail, good initiative and able to work with changing priorities* Ability to travel with potential of up to - 20%Equipment and materials Used* Standard office equipment including computer, copier, fax, telephone, etc.Physical Tasks* Sitting and viewing computer screens for long periods of time* Extensive repetitive hand/wrist movements (telephone console and computer keyboard)* Lifting (up to 30 lbs.)Environmental Demands and Potential hazards* Exposure to hazards from fluorescent lighting, video screens, computers, copiers, faxes, etc.* Environment will range from business office setting to clinical areas such as inpatient unit and clinical screening areas. The position requires contact with biological samples, individuals with potentially infectious diseases and with toxic, harmful, or potentially hazardous compounds, solutions, and medications. Noise levels can range from quiet to moderate volume.

Keywords: Evolution Research Group, Hialeah , Quality Assurance Manager, Executive , Hialeah, Florida

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