Barry Francis, DMin

The Vice President of GCP and GLP, you'll partner closely with our leadership team to refine our overall GxP strategy and QA plan in alignment with both business objectives and regulatory requirements. Quality Assurance and Compliance develops and implements all GxP related to manufacturing, non-clinical, clinical, and pharmacovigilance activities, including, but not limited to research activities, clinical trial management, and pharmacovigilance system oversight. Ensure that Quralis operates under applicable regulatory requirements, guidelines, laws, and established standards and practices. Prepare the organization for commercialization and pre-approval inspection plans.

Independent GLP & GCP Consultant. Focus on Quality Assurance for start-up to mid-sized biotech companies. Supporting QMS infrastructure setup, SOP writing, training, auditing of GLP and GCP supporting facilities and CROs, including Pharmacovigilance and Safety. Inspection readiness support and setup. Utilizing strategic and tactical approaches to ensure that the Quality Assurance Unit works in partnership with Operations Teams and becomes a full collaborator in the development of the Quality Assurance systems. Experience both domestically and internationally. Doing it right the first time!!

• Accountable for creating and implementing global inspection readiness strategy for Agios. Identify Inspection Readiness goals, collaborate with cross-functional leaders to champion inspection readiness. • Collaborate with cross-functional leaders to identify and implement operational oversight and quality activities within clinical development in support of global inspection readiness. • Lead GCP global inspections, response strategy and development and execution of resulting CAPA plans. • Co-lead global Good Pharmacovigilance Practice (GVP) inspections and inspection readiness activities. • Perform cross-functionally to understand organizational needs and complete gap analyses that identify process development/process improvement that is consistent with global GCP principles. • Provide ICH/GCP expertise and consultative guidance related to business initiatives and lead GCP Quality initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities. • Establish Quality Vendor Oversight Program and establish relationships with CRO Quality Team members for the ongoing review of quality and compliance metrics and issues. • Maintain a high level of expertise in global GCP regulations and internal policies and procedures that may impact clinical development. • Lead, develop and motivate a team of GCP Quality professionals.

Under limited supervision, functions as a key member of the Quality Assurance leadership team‬‬‬. Partners with the Vice President of Quality Assurance to ensure synergistic alignment of Operations/Quality Assurance functions‬‬‬‬. Provides leadership for all Quality Assurance quality related activities at the partner and clinical trial sites. • Ensuring deployment of Quality and Regulatory Strategy as approved by senior management‬‬‬‬ • Developing, directing, and maintaining local Quality Systems to support clinical trials on a global basis • Contributing to the development and maintenance of the global quality systems in line with current regulatory requirements, meeting US FDA and European requirements, and others as needed • Support deployment and implementation of HIPAA, good laboratory practices, good clinical practices as well as good manufacturing practices • Collaborating with and supporting Operations leadership and well as Corporate leadership including but not limited to the Director of Clinical Operations and the Chief Medical Officer • Acting as point of contact with regulatory authorities regarding issues at the partner and clinical trail sites as well as (CRO’s) Clinical Research Organizations • Influencing a strong quality and compliance culture at the partner and contractor sites‬‬‬‬ • Act as a SME on any quality/GxP issues at the partner and clinical trial sites • Contributing as subject matter expert for matters relating to formal quality management and regulatory compliance at Mapp’s partner sites‬‬‬ in collaboration with the Vice President of Quality Assurance • Acting as primary contact for discussions on Quality matters with regulatory authorities, key customers and contract research organizations (CROs).

Responsible for leading QA function(s) including managing, coaching and leading 9 direct reports as well as ensuring compliance to quality standards. In addition, accountable for building and maintaining constructive and effective working relationships with functional leaders, external clients, domestic and international regulators and Inspectors. This role also required being a part of the global QA leadership team driving and influencing improvements as required within a CLIA, CAP and ISO 15189 Central Laboratory. Essential Job Duties Include: • Provide leadership for a QA team of 9 QA GCP Auditors, by ensuring individuals have the appropriate education, training and experience to fulfill their role • Ensure resources were available to appropriately execute QA processes, mitigate compliance risks and provide quality oversight of the sites operations • Designed and delivered appropriate training material as required • Hosted Sponsor audits and regulatory inspections – CLIA, CAP, ISO, NY State & FDA. • Acted as QA Management representative during strategic client interactions • Accountable for budgetary planning and cost control for assigned areas of responsibility • Led process improvement and harmonization efforts that promoted best practices

• Network with Clinical Operations Managers to anticipate, track, schedule assessments of CROs and other potential sourcing partners. • Conduct GCP & GLP assessments and audits of clinical third party vendors, resolve assessment observations and make recommendations as to their suitability for use in Clinical Trials. • Representative during FDA/EMA/MHRA (and other regualtory authority) inspections of sites and/or studies and vendors and manage timelines to assure completion of any Agency inspection comments or observations. • Participate in the management/development of GCP & GLP components within the Quality Organization. e.g., authoring and/or the review of Standard Operating Procedures and associated personnel training. • Conduct GCP & GLP co-monitoring visits of CRUs and Investigator Sites when required and resolve issues. • Conduct GLP & GCP audits of clinical third party vendors when required. Resolve audit observations. • Build virtual capacity by identifying, qualifying, and recruiting a team of external auditors to supplement GLP & GCP assessment, monitoring and audit needs. Conducting assessments and audits personally to establish face-to-face relationships to build stronger long-term partnerships. • Monitor changes to GLP & GCP regulations and other developments in the industry and advise management as to their potential impacts on the quality strategy. • Develop new processes and checklists to increase efficiencies. • Conduct GLP assessments and audits of large and small molecule bioanalytical and central labs. • Provide back-up support for the review of small molecule bioanalytical validation and sample analysis reports. • Approximately 10-20% travel, nationally and internationally.

Pre-Clinical and Clinical - formulations and bioanalytical

• Manage and Monitor study activities that included - Oversight of CRO, Central Lab, and other vendors, reporting on study status, and ensuring timely completion within budget. - Train vendors and clinical sites to ensure adherence to the protocol and compliance with ICH/GCP & GLP Guidelines. - Support collection and review of essential document handling. - Significant interface with multiple teams. • Select and monitor clinical sites and supporting Bioanalytical laboratories. • Assist in preparation of clinical study reports for regulatory submissions and scientific publications. • Conduct CRA cross-functions for Phase I First In Human (FIH) protocol monitoring at Wyeth Clinical Pharmacology Unit in Philadelphia, PA and Phase II protocol monitoring at clinical sites. • Initiate and coordinate study start-up/wrap-up activities that include - Protocol and investigator brochure writing and review, - Investigator selection, - Investigator meetings, - Budget planning and review, - Contract preparation, - Vendor selection, - Site selection, - CRF/EDC instruction and review, - CRF and drug supply reconciliation.