WVU Research Corporation Senior Quality Assurance & Auditing Manager in Morgantown, West Virginia
Purpose The purpose of this position is to provide internal and external quality and auditing support to ensure compliance with established health authority regulations and guidance. This position is responsible for planning, coordination, and directions of the quality assurance and auditing policies and procedures across various aspects of the WVU-HSC and WVURC clinical research projects.
This position is responsible to oversee, plan, direct, and coordinate organizational activities including policy formulation, management of daily operations, and resource stewardship consistent with business objectives. It may oversee procurement, human resources, communications, finance, general operations, and/or office support. Provides operational leadership; requires creativity, and interpretive abilities to effectively resolve complex problems. Work effort has significant impact on personnel, budget and operations, producing major organizational, legal and financial results and/or liability.
Duties & Responsibilities Responsibilities are functional in nature, and performed under the nominal supervision of management. Specific tasks include, but are not limited to: 1) Serves as lead auditor during sponsor, regulatory or vendor audits. 2) Conducts and documents assigned audits of the projects and operational processes in accordance with approved procedures, schedules, and formats. Specific audit areas will include but not be limited to a. Trial master/investigator site and project management files b. Project databases (and their development) c. Data management activities and documentation d. Safety reporting e. Employee credentials and training files 3) Responsible for the quality assurance sign off for all final/clinical study reports, verifying that the final submission documents and reports, including the case report forms (CRFs), accurately reflect the raw data. 4) Assesses the compliance of the study data with the protocol and verifies all deviations from the protocol. 5) Subject safety and protection auditing and monitoring as they pertain to: a. Informed consent b. Meeting clinical eligibility requirements as dictated by the appropriate protocol c. Subject satisfaction with various elements of study conduct (Voice of Volunteers- VOV) d. Subject complaints handling and management 6) Drug Accountability and disposition 7) Conduct complex scheduled and unscheduled (when indicated) internal audits and inspections to ensure compliance established with quality assurance processes, standards, global regulatory guidelines and/or sponsor contractual obligations. 8) Write audit reports, manage audit database for clinical audits, assist in the closure of open audit observations. 9) Identify issues impacting the quality and/or integrity of clinical research programs by following the policies and procedures of the University’s Office of Research Integrity. 10) Determine root cause of non-conformance and develops strategies to address issues and minimize risks in a regulated pharmaceutical environment. 11) Perform technical document review and other Good Clinical Practices (GCP) activities in support of clinical development programs. 12) Provide audit reports to management and service as subject matter expert for in-service training on quality guidelines, (i.e. CFRs, GCP, NIH, etc.) 13) Plan and deliver quality services for QA audits, internal site audits, laboratory and file audits for projects. 14) Supports all quality systems associated with GCP operations to be inspection-ready at all times. 15) Maintains independence from clinical trial execution, CAPA, quality board, etc. to allow for non-bias auditing of cross-functional teams (i.e. recruiting, screening, study unit, training, data, quality, IT, Finance, etc.). 16) Perform vendor audits as needed which may involve occasional travel. 17) Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
Supervisory/Lead Role This position reports to the AVP of Clinical Research Operations, and takes input and direction from the AVP of CTSI. This position will direct and coordinate operational function(s) under general guidance. Personnel supervision and work coordination of staff are required. In addition, general sharing of knowledge and team participation is expected in the role. Program, project or activity lead responsibilities will occur in this position. Normally receives minimal instructions on routine work, general instructions on new assignments. Sharing of knowledge with others and team participation is expected in the role as well as training in areas where serving as a subject matter expert. Program, project or activity lead responsibilities will occur or be assigned in this position.
Physical Demands Activities require manual skill to provide and/or alter services and/or products. Manual dexterity used in operating office equipment. Prolonged periods of sitting, and the ability to walk short distances is required. Use of elevators and/or stairs is routine. Activities are predominantly non-manual though some manual work not directly involved with altering or transporting of products may be included.
Work Environment Work is performed in a normal clinic/hospital setting. Exposure to diseases, chemical and biologic hazards is possible. The incumbent must comply with all safety procedures and clothing/equipment requirements. Incumbent is responsible to know and comply with all safety procedures. Limited travel for vendor audits is expected.
The following items have been determined as possible job exposures of this position requiring WVU EHS medical monitoring: 1) Contact with Human Blood or Other Potentially Infectious Materials (OPIM)- includes human body fluids other tan feces, urine, tears, and sweat. 2) Human Pathogen and Biological Research (BSL2+/3)- for those working with or in proximity to certain biological agents. 3) Patient Contact- having contact with a patient, or with potentially contaminated items including (but not limited to) blood and/or body fluids
Requisite Qualifications Education and/or Experience 1) Bachelor’s degree in an allied health discipline, nursing or a related field; and 2) 5 - 7 years of experience in regulatory and/or quality-auditing aspects of pharmaceutical and/or medical devices industries or government sponsored clinical research studies; 1 - 2 of which must include supervisory or program management experience, including gap analysis and solution proposals; or 3) An equivalent combination of education and experience.
Certifications, Licenses, Registrations 1) If not certified previously, incumbent must be willing to enroll into a Clinical Research Auditing Certification (i.e., CQA) Program within 6 months of hire with completion of the requirements within 12 months of hire.
Skills, Knowledge, Abilities 1) Working knowledge of regulatory aspects of pharmaceutical and medical devices industries and government sponsored clinical research studies including institutional review board (IRB) regulations, US FDA Code of Federal Regulations (US FDA CRF) & Guidances, National Institute of Health (NIH), International Conference on Harmonization (ICH) GCP, Medicines and Healthcare Products Regulatory Agency (MHRA), Therapeutic Products Directorate (TPD) or Health Canada, etc. 2) Working knowledge of developing investigational new drug (IND) or abbreviated new drug applications (ANDA), or premarket approval (PMA), and in vitro diagnostics (IVD) safety reports. 3) Skilled at problem solving. 4) Excellent oral and written communication skills. 5) Skilled at creating and implementing effective QA and auditing programs. 6) In depth knowledge of GCP regulations, quality systems, quality assurance, quality control and GCP quality audits. 7) Strong problem-solving, risk assessment and impact analysis abilities. 8) Strong work processing skills and understanding and the ability to handle stress and work under pressure. 9) Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. 10) Strong time management skills and ability to prioritize and manage multiple projects simultaneously. 11) Computer proficiency and familiarity with use, including Microsoft Office. 12) Demonstrated ability to work effectively in both cross-functional teams and independently is required. 13) Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. 14) Ability to write reports, business correspondence, and procedure manuals. 15) Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 16) Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. 17) Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. 18) Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. 19) Must be able to read and understand large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes.
Behavioral Competencies 1) Technical skills – Strives to continuously build knowledge and skills; pursues training and development opportunities; assess strengths, weaknesses, and shares expertise with others. 2) Problem solving – Gathers and analyzes information, identifies problems, develops alternatives, uses reason even when dealing with emotional topics and works well in groups and resolves matters timely. 3) Internal & External Customer Service – Manages difficult or emotional matters with objectivity and openness; responds promptly to needs and requests for service and assistance; meets commitments and dates, notifies others if change occurs; provides, solicits and applies feedback; and builds goodwill through balanced contributions, positive approach, respect and support of others. 4) Communications – Demonstrates group presentation skills, participates in meetings, listens and gets clarification, is responsive and speaks clearly and persuasively in positive and negative situations. Writes and edits clearly and informatively, varies style to meet needs, presents numerical data effectively, and able to read and interpret written information. 5) Organizational Support – Aligns work and develops strategies to meet organizational goals; seeks to improve and promote quality; demonstrates accuracy and thoroughness; and upholds organizational expectations and values. 6) Self-Management – Responds to management direction; resourcefully adapts to changes in work environment and circumstances; responds well under pressure and manages competing demands; takes calculated risks, asks for and offers help when needed; exercise discretion and sound judgment; is tactful and responsible for own actions. Adheres to work schedule and complies with leave management responsibilities.
Requisition Number: 16-0080
Title: Senior Quality Assurance & Auditing Manager
Post Date: 6/20/2016