Quality Assurance/Compliance Program Manager

Company: Vitalief
Location: New Brunswick
Posted on: May 3, 2022

Job Description:

Job Description Overview Vitalief is a fast growing, "best of breed" Clinical Trial Solutions Company. We are seeking a talented and ambitious GMP Quality Assurance/Compliance Program Manager to join our exceptional team, that has a passion for establishing credibility with our clients by supporting our clients in planning and execution of successful clinical trials. Every trial is different and requires a solution that will optimize outcomes. Our approach explores innovative ways of delivering services in a distributed model that can support both decentralized and centralized trials. If you are interested in being part of a culture that includes the ability to have a voice challenging the status quo with novel thinking, flexible work environment, transparent and open communications, career pathing, and a variable incentive / reward system, then we want to speak with you Note: Work is 100% on-site in New Brunswick, NJ, with the potential for hybrid (part-time on-site / part-time remote) work. Responsibilities: Develops Quality Management Program for Cell Therapy Program Develops and maintains GMP required documentation (including SOPs (standard operating procedures), controlled forms for manufacturing, personnel training, GMP facility use and maintenance, equipment maintenance, reagents validation, deviations, CAPAs etc.) Develops and maintains phase-appropriate quality systems for both clinical and commercial manufacturing environments. Approves the design and oversees the implementation of GMP Facility quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools. Assists with development and validation of the Quality Control Tests for in-process and final product testing as well as for demonstration of the proper functioning of the equipment. Ascertains timely training, retraining and assessment of the competency of all personnel involved in GMP manufacturing on all equipment, procedures and/or issues identified during the analysis and assessment of the Quality System attributes and investigations of the incidents and deviations occurred. Provides QA oversight and leadership to ensure timely disposition and delivery of GMP compliant manufacturing drug products that are fit for purpose. Acts as subject matter expert for quality during audits and regulatory inspections. Leads all activities required for preparation and hosting of the audits and regulatory inspections. Directs and independently performs quality assurance activities in support of GMP Cell Processing program areas. Directs and independently monitors and assesses quality performance and compliance of operational systems. Leads improvement projects dealing with broad or complex issues, or with strategic impact. Advises staff on the development of corrective action and preventive action plans. Acts as subject matter expert for quality during audits and regulatory inspections. Oversees direct subordinates of the Quality Assurance Unit. Required Skills: Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. Equivalent experience, education and/or training may be substituted for the education requirements. Minimum 7 years of specialized experience performing activities of a quality professional in a healthcare or drugs/biologics/medical devices GMP manufacturing setting or as an auditor of the regulatory agencies such as FDA, FACT etc. Minimum 10 years total relevant experience with a combination of specialized experience and clinical or technical work. Minimum 5 years of experience which includes supervision of Quality Assurance activities or oversight, management or consulting services for the new development and implementation of the GMP units. Broad knowledge of quality assurance methods, principles, and practices, including basic statistical analysis and sampling techniques, auditing, process control, validation, and process improvement methodologies. Expert knowledge of regulations and accreditation standards applicable to cGMP facility and cell therapy program. Strong work knowledges of quality system and regulatory requirements (21 CRF Part 11/210/211, 21 CFR 1271, ICH 8, ICH 9, ICH 10) in both U.S. and E.U. id required. Familiarity with FACT (Foundation for the Accreditation of Cellular Therapy) Accreditation Standards is a plus. Effective oral and communication skills. Expert ability to analyze and interpret observational, operational, and quality data to monitor process performance and to determine if products and services are performing within defined specifications. Expert ability to conduct studies and investigations for problem analysis, and risk assessments to assist with development of logical and well-documented recommendations for process improvement and corrective actions. Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint. If interested in finding out more about opportunities with Vitalief, please contact: Glenn Murani Director of Talent Acquisition Vitalief Inc. glennvitalief.com (610) 209-1083 https://www.linkedin.com/in/glennmurani/ https://vitalief.com/ LI-DNI Powered by JazzHR YPlvMYuzj9

Keywords: Vitalief, New Brunswick , Quality Assurance/Compliance Program Manager, Executive , New Brunswick, New Jersey