• My name is John Batty, I am a Senior Consultant for Pace Life Sciences. I am a Bio-pharmaceutical professional with extensive experience (25 years) in Quality Operations including Quality Assurance/Quality Control (QA/QC), GXP (GLP/GMP/GCP) Compliance, FDA/EU audits and inspections, FDA QSR and ISO, manufacturing support, and creating partnerships of internal and external alliances critical to achieving organizational objectives. Developed and implemented GQD/CTQ (general quality document/critical to quality) documents/policies [i.e., standard operating procedures (SOPs)] in support of the QC department. Established and managed an environmental monitoring program and water testing program in support of the facilities operations. Developed and implemented quality management system (QMS) for tracking QA compliance to meet internal and external regulatory GXP (GLP/GMP/GCP) compliance regulations and policies. Implemented a course of action to harmonize and accelerate the collaborations between the QA department with other internal departments (Clinical, Vaccine Discovery, and Manufacturing) to ensure successful implementation of bio-pharmaceutical manufacturing processes. Have the knowledge of sterile pharmaceutical manufacturing technologies and FDA/EMA and other applicable GMP regulations for Investigational Products. Review and approve QMS documents related to assigned client projects, such as SOPs, Material and Product Specifications, Master Production Records, Validation Protocols and Reports.

• Provide leadership and vision for developing and improving the IDT QMS.• Define key quality assurance programs based on industry best practices and regulatory multi-jurisdictional requirements and projected enhancements.• Anticipate emerging quality issues likely to impact the IDT QMS and develop strategies for influencing the outcome of key issues and recommend appropriate actions based on compliance risk and operational priorities to the IDT leadership team.• Assist with hosting external Client audits and provide support to QA Director during regulatory audits. Issue and track ECARs, generate response letter, track CAPA closures and measure CAPA effectiveness.• Manage QA compliance aspects of an assigned cGMP manufacturing projects by acting as QA Representative and communicate quality matters to clients.• Develop and negotiate the quality agreement for incorporation in the CMO contract for service for cGMP manufacturing projects.• Oversee the QA Document Control Group and responsible for developing and maintaining the QMS program infrastructure to comply with FDA, EMA and other applicable international GMP regulations.• Oversee the QA GMP Compliance Group and evaluate trend reports, data and essential quality information to be used for the management review process and identify key quality objectives and metrics to measure the effectiveness of the quality management system.• Establish the chair the Materials Review Board (MRB) for all significant deviations ensuring that sound decisions are applied to adequately investigate root cause and ensuring appropriate CAPAs are applied.• Provide oversight and guidance to site staff on cGMP requirements. Serve as the QA technical expert, providing input and guidance on quality aspects of product development issues.• Provide effective Quality leadership during Regulatory Authority inspections and Customer-Client assessments and lead FDA and other regulatory agency interaction as it relates to the IDT QMS.

• Apply knowledge of sterile pharmaceutical manufacturing technologies and FDA/EMA and other applicable GMP regulations for Investigational Products.• Develop SOPs pertinent to QA GMP Compliance and Lot Release activities.• Lead the Quality Assurance Lot Release Group by example while ensuring that client projects are tracked and completed in a timely manner.• Function as the QA Lot Release Group Lead when the QA Manager is off-site.• Assist with hosting external Client audits and provide support to QA Director during regulatory audits. Issue and track ECARs, generate response letter, track CAPA closures and measure CAPA effectiveness.• Conduct GMP and other Quality Management System (QMS) trainings.• Manage QA compliance aspects of an assigned cGMP manufacturing projects by acting as QA Representative and communicate quality matters to clients.• Review and approve QMS documents related to assigned client projects, such as SOPs, Material and Product Specifications, Master Production Records, Validation Protocols and Reports, etc.• Manage Batch-Related Deviation investigations in the NextDocs, eQMS, evaluate Root Cause Analysis results and CAPA responses and provide investigation management support to investigators and CAPA owners.• Review in-process and lot release test results and manage the release of the assigned client product based on the approved Product Specification (BOT).• Prepare the Lot Release Dossier and related documentation and provide it to the QA Director for final disposition.• Perform general QA functions by reviewing validation protocols and reports, QC EM and Utility data and temperature charts for compliance with IDT Biologika Corporation requirements.• Conduct internal GMP and ISO QMS audits as applicable, issue ICARs, generate reports, track CAPA closures and measure CAPA effectiveness.• Support other QMS programs such as Deviations, Complaints and OOS investigations, risk assessments, and change controls.

• Review of analytical records generated during the testing of vaccines for compliance to current Good Manufacturing Practices (cGMP) and Novavax Standard Operating Procedures (SOPs). Records include, but are not limited to lot release, stability and raw material test records.• Review of records related to the general operation and upkeep of a GMP Quality Control laboratory, including but not limited to, records associated with preparation, qualification, and control of standards and controls, test sample chain of custody and preparation, qualification, and control of laboratory reagents.• Provision of QA support for the stability program, including review and compilation of stability time point packages and reports, review of stability information submitted in Regulatory filings, participation in resolution of deviations and non-conformances related to stability testing, and review and input for stability protocols, amendments, and reports.• Review of analytical method qualification and validation protocols and report packages.• Provide QA support and oversight for resolution of deviations and non-conformances related to Quality Control activities, including investigation of Out of Specification results.• Provide QA review and input for QC/analytical SOPs, test methods, and protocols.• Provide review and input for generation of new or revised QA SOPs and other controlled documentation. Author quality documents as assigned.

•Supports internal audits of manufacturing, quality control, analytical testing to ensure compliance with SOP and regulatory per the requirements of the self-inspection program. •Ensure compliance to internal and external guidelines for Quality Assurance through providing training, accurate & timely reporting, effective investigations, root cause analysis, and compliance with international (e.g. FDA, ISO) regulations. •Ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers. •Recommend the necessary corrective actions for all observations generated by the audits. Monitor the corrective actions to ensure completion and successful implementation. •Ability to communicate and work effectively with internal customers. •Demonstrated technical ability and skills in assigned work area include product, process and /or testing knowledge.•Support operations ensuring that applicable Quality Systems requirements are met (e.g. Change control, document control, MPR, SPR, validation, etc.).•Ability review and understand analytical data.•Ability to audit Quality Control and Manufacturing Suites for Compliance.•Electronic system usage with tools such as Trackwise, LIMS, PCS and SAP.

• Ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers. • Recommend the necessary corrective actions for all observations generated by the audits. Monitor the corrective actions to ensure completion and successful implementation. • Ability to communicate and work effectively with internal customers. • Demonstrated technical ability and skills in assigned work area include product, process and /or testing knowledge.• Support operations ensuring that applicable Quality Systems requirements are met (e.g. Change control, document control, MPR, SPR, validation, etc.).• Ability review and understand analytical data.• Electronic system usage with tools such as Trackwise, LIMS, PCS and SAP.

•Supervise and direct overall activities in quality control quality control in the manufacturing of implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, pacemakers, electrophysiology catheters, mapping and visualization systems, vascular closure devices, heart valve replacement and repair products, and neurostimulation devices. •Supervise a day and night staff of Quality Control Technicians, insuring that each team member is appropriately trained and performing in compliance with FDA Quality Systems Regulation (QSR) and International Organization for Standardization (ISO) and SJM Quality System and Policy.•Assure that inspections are completed on time and per approved inspection procedures. •Prepares reports and documentation to support production needs.•Work with manufacturing, engineering, and other functional groups to maintain continuous work flow in all operations.•Lead quality system audits of facilities and medical device manufacturing suites.•Work with planning and manufacturing in order to provide QC support to coordinate work flow and personnel to achieve targeted goals and meet schedules.•Provide reports and metrics utilizing the material requirements planning (MRP) software as requested to ensure compliance to organizational objectives.

•Proficiently plan production suite(s) monitoring and cleaning activities such as preparing weekly and monthly monitoring schedules, mapping out the sites’ for viable and non-viable monitoring, and ensuring proper equipment (i.e. particle counters and Surface Air System (SAS) air samplers) is being utilized for the appropriate suites. •Collaborate with various departments (i.e. manufacturing, clinical, statistics, and vaccine discovery) to ensure that the most appropriate measures are being taken to continue to improve production methods, equipment performance, and quality of product and/or process development.•Diligently review raw data batch records under cGMP specifications, write and review Corrective/Preventive Actions (CAPA)/Deviations, execute Installation Qualification/ Operational/Performance Qualification [IQ, OQ & PQ (IOPQ)], and generate out of specification (OOS). •Implement TrackWise for tracking of quality documentation, including revision of applicable SOPs and company training.•Plan and coordinate quarantine and release of current Good Manufacturing Practices (cGMP) materials to different departments.•In charge of obtaining data and samples from different sites within Biosafety Laboratories (BSL2 and BSL3-Grade A), manufacturing suites, and biosafety cabinets (BSC), (i.e. collecting RODAC/contact plates and swabbing) to assess for mold/bacteria.•Meticulously perform water testing using Total Organic Carbon (TOC) analyses, Limulus Amebocyte Lysate (LAL) assays, and Bioburden to ensure product quality and compliance with regulatory requirements for manufacturing.•Audit 3rd party suppliers.•Actively participate in weekly employee meetings focused on critical aspects of the facilities, manufacturing departmental goals and quality control departmental task and schedule. •Assuring compliance with current Good Manufacturing Practices (cGMP) and International Organization for Standardization (ISO) regulations within the Quality Control department.