^{Seeking a seasoned, multi-disciplined Quality Assurance professional with experience in managing, developing, and delivering quality programs and oversight with various therapeutic products within the life sciences industry. This consultant will support and partner with our pharmaceutical, biopharmaceutical, diagnostics, and medical device/combination clients through quality systems design and development, establishing processes and procedures, and quality operational activities.} 

^{Responsibilities}

• ^{Perform Quality systems assessments/audits to identify deficiencies according to client quality and regulatory standards and guidance}
• ^{Develop and establish quality systems programs and elements in processes and procedures, instructions, and other documentation} 
• ^{Establish core quality programs, oversight and controls for Document Management, Change Management, Deviation/Investigation Management, and Training Management}
• ^{Provide Quality expertise and development/oversight for our clients both internally and externally for Supplier/Vendor audits and CDMOs} 
• ^{Provide technical and operational support for resolving quality deficiencies and remediation activities} 
• ^{Prepare clients for audit readiness, risk management, and documentation review}
• ^{Perform risk assessment for cGMP compliance and risk programs} 
• ^{Provide Quality review, certification and management of batch records and work orders to ensure compliance with SOPs and cGMPs for lot release and disposition} 
• ^{Plan, execute and provide report for audits at suppliers, contract services, and within the internal quality team} 
• ^{Participate in the development, implementation, and maintenance of the company’s quality management systems} 
• ^{Lead investigations for a variety of non-conformances which may include deviations, CAPA, OOT, AA, or OOS activities} 
• ^{Gather information/data, prepare investigation reports, and shape corrective/preventive actions to resolve recurring problems with permanent solutions} 
• ^{Support in pre-approval inspection (PAI) readiness of internal and external systems} 
• ^{Work cross-functionally with various departments to ensure Quality culture and processes align with project objectives and timelines}
• ^{Review manufacturing and facility operations records and documentation associated manufacturing of products} 
• ^{Assist during regulatory inspections, due diligence audits, serving as QA escort when needed} 
• ^{Create, review and maintain quality records/metrics and make process improvement recommendations to management}

^{Qualifications}

• ^{Bachelor's degree within a life science or related field required; Master's degree preferred} 
•  ^{5 years of experience within Pharma/Biopharma, Medical Device, or Diagnostics industry} 
•  ^{Extensive experience working with Quality for various products in support of clinical/commercial manufacturing} 
• ^{Experience in the application of Quality Assurance principles, concepts, industry practices, and standards}
• ^{Knowledge of cGMP standards, FDA regulations, US standards 21CFR210, 21CFR211, 21CFR11, 21CFR820, ICH Quality Guidelines, Quality System Regulations and ISO standards including 13485, ISO 9001, ISO 14971}
•  ^{Significant experience with a variety of software including MS Office; Project, Visio, LIMS, and EDMS}
• ^{Excellent communication and leadership skills as well as a strong work ethic}