PRINCIPAL QTA

Principal Qta - Liaisons with the client for training issues, schedules training for new employees, identifies training gaps, and assists with the development and delivery of training programs and curriculums. Performs call and documentation review and ensures program consistency with PPD and client policies and procedures including SOPs, protocols, and FDA regulations. Provides documentation and feedback to the Operations management. Essential Functions- Coordinates program training including developing curriculum and documenting and maintaining training records for all staff. Works with staff for training that includes clinical content. - Integrates training with the client while negotiating organizational differences in culture, management structure, and staffing. - Liaisons with the client, PPD management, and staff for all training related topics. Maintains program training documentation in audit-ready status. - Conducts call and documentation review of staff and monitors accuracy and completeness of information provided and ensures program consistency relative to compliance with PPD and client policies/procedures. - Evaluates non-clinical calls and documentation of staff. Evaluates quality trends across the program and provides feedback to the management team. - Documents all quality reviews and provides feedback to management. - Monitors effectiveness of training and observes training sessions, trends and assesses changes in employee performance. Modifies training to increase beneficial outcomes. Maintains program knowledge including client SOPs, product information, and documentation practices. - May perform other duties as assigned. Qualifications:Education and Experience:High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. BS degree in a science or health science field preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years) or equivalent combination of education, training, and experience. Minimum of 1 year experience with PPD Medical Communications and 1 year of experience in a healthcare setting, or 2 years of experience with PPD Medical Communications, or minimum 2 years experience in a regulatory or quality assurance position for the pharmaceutical/biomedical industry. Knowledge, Skills and Abilities:Understanding of FDA or local regulationsAbility to perform call/document review efficiently and provide clear and concise feedbackOrganizational and time management skillsAttention to detail and ability to multi-taskEffective verbal and written communication skillsGood problem solving skillsProficiency in Microsoft OfficeAbility to train and mentor othersAbility to work in a team environment and/or independently as neededManagement Role:No management responsibilityWorking Conditions and Environment:Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements:Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.