CQV Manager

Directly responsible for the successful delivery of compliance projects to IPS’ clients Works with IPS CQV/Project management team to develop and apply quality practices for all projectdeliverables and business practices. In conjunction with the Project management team, performs projectaudits to ensure all project goals are being met and compliance services are offered as a value-addedproduct to IPS’ clients. Promote efficiency in staff utilization. Manages and assigns regional resources to meet projectrequirements. Works with other Regional Managers and other IPS disciplines to maintain targeted /budgeted utilization. Tracks staff assignments, makes resource projections, and makes necessaryadjustments as required. Prepares workload forecasts to support staffing management. Leads, mentors, trains, and manage team of compliance staff assigned to the respective regional office.Assists and mentors’ staff to set performance and career goals. Provides routine feedback and conductsformal time-based performance reviews. Implement corrective action plans as required. Generates and performs C/Q/V deliverable activities, audits, and other compliance services as required, tomeet project requirements and personal billability goals. Works with potential new and existing clients toinitiate projects following current industry practices. Performs strategic and master planning activities toassure projects are initiated/started “on the right foot”. Preparation of project monthly report, Management of various GEP and GMP documents, QMSDocument review and Gap analysis Ensures the quality, accuracy, and completeness of overall work as to CQV Department, compliance withestablished IPS and client standards, procedures, codes, and ordinances. Guidance for implementation of Biotech/Pharmaceutical industry standards in generating and updatingsupporting documentation such as P&IDs, material and equipment specifications / datasheets, and userrequirement specifications Track Quality deliverables by strong interaction with inhouse team, clients & vendors

Qualifications & Requirements

Must be able to demonstrate competency in performing the responsibilities of a CQV Manager Bachelor’s degree in engineering or a related field preferred A minimum of 10 years (Manager) to 15 years (Director) of experience in Pharmaceutical, Biotech, MedicalDevice Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC,FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software. Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes. Detailed experience in the discipline of GMP/Validation with a knowledge and understanding ofpharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirementsand cGMP regulations Progressive ability, capacity, and aptitude in administration to plan, organize, supervise, and coordinatetechnical work and to obtain cooperation from others. Analytical thinking, structured problem-solving skills,superior communications skills, team building and strong work ethics. Must be able to build rapport withdepartment staff