Jack B. Brown

* ******** **** *******, ** ***** C. 914-***-**** H. 845-***-**** E-mail: ad2j7g@r.postjobfree.com

EDUCATION

**/**** ******** ** *******, Computer Science

Almeda University, Boise, ID USA

09/2004 Master of Science, Engineering Technology

Almeda University, Boise, ID USA

EXPERIENCE

08/2022- 10/2023 Johnson & Johnson (Janssen) (Biotechnology) Raritan, NJ USA

Quality Leader

Responsible for initiating, reviewing, and approving post-market investigations for deviations, non-conformances, and complaints for CMC small molecule manufacturing for gene and cell therapy products of Janssen. Ensured the quality assurance of all internal and CMOs sites working with Janssen to conform to the pharmaceutical quality standards and the regulatory authorities (FDA & EMA). Approved Batch release for lot disposition.

Provided Sterile Manufacturing Quality oversite. Monitored solution/formulation prep, terminal sterilization, aseptic fill, clean room, isolator fill, automated inspection, lab scale equipment, and finishing/packaging processes. Reviewed manufacturing, analytical, and supply chain deviations, investigations, and change controls. Reviewed OOS/OOT investigations.

Utilized MS Teams, MS Office, and TrackWise. Reviewed incidents for appropriate and timely investigation handling, corrective, and preventive action.

Participated in reducing lag time in conducting proper deviation investigations and lowering the deviation occurrence rate through embedded QA expertise on the manufacturing floor.

06/2022- 09/2022 Vaccitech, (Biotechnology) Baltimore, MD

Interim Sr. Director of Quality Assurance

Worked closely with Vaccitech Staff to advise and oversee GCP and GMP compliance in the Clinical, Laboratory, and Manufacturing groups in accordance with local and international quality requirements. Review and approve key quality documents, including SOPs, Policies, Forms, batch documentation, validation/qualification documentation, and Quality Agreements.

Coordination of labeling review and approval throughout the E2E labeling process, which includes preparing labeling components for submission to regulatory agencies and participating in labeling negotiations with agencies, resulting in product approvals or labeling.

Provided quality management support for developing and implementing the Pre and Post Market/R&D Quality Management System (QMS), including SOPs, Deviations, CAPA, Change Control, Audits, risk management, and vendor management.

Ensuring good practices (GxP) are communicated, adopted, and implemented throughout the organization by maintaining current knowledge of local and international regulations;

Providing Quality expertise and oversight internally to project teams and other departments

Performing internal, CSP, clinical site, CDMO, and study-specific audits. Supporting the risk-based annual External/Contract Service Provider (CSP) audit program and maintaining the Approved Supplier List and internal audit program by creating an annual internal audit schedule.

Supported selection and implementation of a global electronic Quality Management System (eQMS).

Tracked quality metrics/trending data of compliance issues for all clinical phases.

Developed clinical trials product complaints process and forms, ensuring compliance with clinical SOPs, clinical quality processes, and GCP regulatory standards for Phase I, II, and III clinical trial studies.

07/2021-07/2022 AstraZeneca, (Biotechnology) Gaithersburg, MD

Senior Labeling Specialist

Provided oversight for GxP quality in the supply chain for CMC manufacturing of Bulk Drug Solution/API to finishing sterile fill/aseptic small molecule manufacturing for injectable vaccine products at the CMO site.

Responsible for assuring the quality of materials received by AstraZeneca from the designated supplier portfolio and will proactively ensure GMP and regulatory compliance during supplier-related projects. Drive quality improvements at the supplier as part of a cross-functional team.

Responsible for the Quality System oversight of supplier-related product quality complaints, change controls, deviation investigations, issue management and escalation, and Quality Agreements between AstraZeneca and External Suppliers; and the preparation and submission of Supplier Quality Risk Assessments and support to Regulatory Agency inspections of supplier sites and site transfers.

Provided oversight and guidance to the Site Quality/Manufacturing Operations, functions including but not limited to documentation, deviation, CAPA, and Change Control. Utilized MS Teams, MS Office, TrackWise, and Veeva eQMS.

10/2021-03/2022 Curis, Inc (Biotechnology) Lexington, MA USA

Senior GMP Quality Consultant/Project Manager

Oversaw the generation and review of documents used in GMP activities such as quality agreements, COAs, analytical validations/transfers, process validations, master and executed batch records, label proofs, specifications, and change controls. Provide CMC experience as a QA liaison, tablet manufacturing, CDMOs, and a GMP lead auditor.

Executed batch record review and batch disposition of Drug substances, Drug products, and Finished Products. Quality review of stability analytical data and reports.

Review of executed clinical labeling batch records and labeled lot disposition to US and EU

Review/approve clinical labels for use in the US and EU. Tracked quality metrics/trending data of compliance issues for Phase I, II, and III clinical trial studies.

Contribute to vendor management program by evaluating questionnaires, audit reports, and risk assessment documents for manufacturers, analytical laboratories, and other vendors.

Review and approve manufacturing, analytical, and supply chain deviations and investigations prior to lot disposition. Review OOS/OOT investigations. Performed external audits and participated in the evaluation/selection of CMO/CROs and other clinical and non-clinical service providers.

05/2021-10/2021 Johnson & Johnson (Janssen) (Biotechnology) Bloomington, ID USA

Strategic Business Management

Provided cGMP oversight in a Technical Operations capacity for the entire CMC manufacturing process of Bulk Drug Solution/API to finishing a sterile fill/aseptic small molecule manufacturer for Injectable Vaccine Products at the CMO site.

Provided Sterile Manufacturing Quality oversite. Monitored solution/formulation prep, terminal sterilization, aseptic fill, isolator fill, automated inspection, and finishing/packaging processes.

Overseen sterile fill for bottle/vial finished product manufacturing, batch record review, environmental monitoring, facilities maintenance, materials handling, and validation per regulatory and site requirements.

Responsible for Batch Records review and product release. Reviewed data and significant deviations identified in batch records and submitted a summary of findings with management recommendations.

Reviewed incidents for appropriate and timely investigation handling, corrective, and preventive action. Participated in reducing lag time in conducting proper deviation investigations and lowering the deviation occurrence rate through embedded QA expertise on the manufacturing floor. Responsible for training/mentoring full-time staff on cGMP and Aseptic techniques.

09/2020-05/2021 Gilead Sciences, (Biotechnology) Morris Plains, NJ USA

Principal Investigator

Responsible for leading GxP investigations related to small molecule Biologics Manufacturing (i.e., Upstream and Downstream) to support clinical/commercial Biotechnology Products. Work with manufacturing and QA teams to agree on appropriate CAPAs as needed. In addition, I reviewed, revised, or created Standard Operating Procedures, Validation Protocols, and Risk Assessments. I utilized MS Teams, MS Office, and Veeva eQMS.

Lead significant and critical deviations related to biologics Manufacturing or Laboratory Testing to support clinical and commercial biotechnology products.

Subject Matter Expert in Quality and Compliance in the biopharmaceutical industry.

Coordinated and follow-up with personnel/department managers where the event occurred to gather additional information, facts, documents, and applicable data for deviations, change controls, and CAPAs.

Utilized root cause analysis techniques during the deviation investigation process and performed a prompt and thorough investigation to comply with associated regulatory requirements.

Created, reviewed, and approved appropriate policies, directives, and procedures aligned with relevant governmental regulations and guidelines. Supported Quality Compliance management to maintain inspection readiness and compliance during regulatory agency inspections.

01/2021-04/2021 Moderna, Inc. (Biotechnology) Norwood, MA USA

Sr Product Quality Assurance Complaint Investigator

Responsible for conducting complaint investigations, including intake, reportability assessment, investigation, and closure. They proactively involved cross-functional team members during investigations, including, but not limited to, members from R&D, Manufacturing, Technical support, Logistics, Field Service Engineers, and CMOs to determine root cause and corrective actions as needed.

Participating in Product Care and/or CAPA meetings and providing support as needed

Detailed complete and accurate findings regarding each complaint investigation, including the conclusion and any corrective actions taken

Maintain the complaint and SCAR records as required by regulations

Communicating findings to technical services and management in concise summary formats

Participating and supporting the analysis, tracking, and trending of complaints data on a weekly and monthly basis for Technical and QA meetings

Participate and provide vital records and support for internal or external audits

Collaborating with co-workers to meet business objectives and improve team capability

Working on other quality department assignments with broadly defined goals as assigned

Solve non-routine issues, challenges, and problems within the field of specialization

Perform supplier corrective action reports with CMOs. Utilized MS Teams, MS Office, and Veeva eQMS.

08/2019– 09/2020 Regeneron Pharmaceuticals, Inc. (Biotechnology) Rensselaer, NY USA

Consultant, Drug Product Manufacturing

Responsible for conducting and writing investigations for deviations, non-conformances, and complaints for aseptic/sterile manufacturing for Biologic vaccine products of Regeneron. Ensure the quality assurance of all CMOs sites working with Regeneron conforms to the pharmaceutical quality standards and the regulatory authorities (FDA & EMA).

Reviewed deviations that impacted the product quality and the associated CAPA to ensure appropriate and effective mitigations.

Tracked and reported on plant quality Key Performance Indicators. Trained and directed QA Operations Teams within CMC. Utilized Risk Management controls based on ICH Q9 guidelines.

Determined that products meet FDA commitments and customer specifications and approved products for release to customers. Ensured Compliance with GCP/GLP regulations.

Provided oversight and guidance to the Site Quality/Manufacturing Operations, functions including but not limited to documentation, deviation, CAPA, and Change Control. Utilized MS Teams, MS Office, and Veeva eQMS.

10/2018 – 08/2019 Emergent Bio-Solutions, (Biotechnology) Baltimore, MD USA

Senior Consultant, Quality Assurance Compliance

Responsible for conducting and writing investigations for Pre and Post Market Quality Systems such as deviations, non-conformances, and complaints for aseptic/sterile manufacturing for Biologic products of Emergent. Ensured products complied with FDA and other health authority regulations and customer specifications for product release.

Verify that US GLP/GCP requirements, industry practices, International Conference on Harmonization (ICH) Guidelines, internal policies, and regulatory compliance procedures were met. Reviewed data and significant deviations identified in batch records

Reviewed deviations that impact the product quality and the associated CAPA to ensure appropriate and effective mitigations. Tracked and reported on plant quality Key Performance Indicators.

Utilized MS Teams, MS Office, and Veeva eQMS.

04/2018 – 9/2018 Pfizer Corp, (Biotechnology) McPherson, KS USA

Senior Consultant, Manufacturing and Investigations

Responsible for conducting and writing investigations for deviations, incidents, quality issues, and complaints for aseptic/sterile manufacturing for CMC products. Ensured corrective actions and follow-up reports were tracked and completed—physical inspection of equipment, buildings, and facility grounds for internal, regulatory, or customer audits.

Determined that products meet FDA commitments and/or customer specifications and approved products for release to customers. Ensured Compliance with GCP/GLP regulations.

Utilized TrackWise eQMS to document and track compliance issues.

Provided oversight and guidance to the Site Quality Operations, including but not limited to documentation, deviation, CAPA, and Change Control. Tracked and reported on plant quality Key Performance Indicators. Lean Six Sigma Yellow Belt Certified by Pfizer.

02/2015 – 04/2018 Acorda Therapeutics, (Biotechnology) Ardsley, NY USA

Senior Manager, Quality GMP, Compliance, and Investigations

Responsible for overseeing Pre/Post-market product complaints and CAPA/SCAR for drug and combination products within this biotechnology company. Performing investigations related to product complaints and non-conforming events to ensure compliance with the FDA and other worldwide health authority cGxP and GVP regulations, guidelines, site SOPs, and industry standards. Evaluate, review, and approve service providers and Quality/Service Agreements. Provide recommendations for corrective and preventative action to the Senior Management team. Led Non-conformance Monitoring team. Provide contract manufacturing oversite for CMC production and site auditing. Develop clinical trials product complaints process and forms, ensure compliance with clinical SOPs, Clinical Quality processes, and GCP regulatory standards. Utilized Risk Management guidelines based on ICH Q9. Led Quality Compliance management to maintain inspection readiness and compliance during regulatory agency inspections.

Led Non-conformance Monitoring team. Provide contract manufacturing oversite for CMC production and site auditing. Responsible for ensuring the quality assurance of all Sterile Manufacturing CDMOs sites working with Acorda and verifying conformance to the pharmaceutical quality standards and the regulatory authorities (FDA & EMA). Responsible for Batch Records review and product release.

Responsible for quality assurance in the product development environment.

Performed investigations for pre- and post-market product complaints and wrote deviations, non-conformances, and change controls for manufacturing. Developed and applied Risk Management/Assessment principles for quality as applicable. Filed Field Alerts with FDA.

Participated as a member of the Quality and Regulatory Leadership Team.

Tracked quality metrics/trending of compliance issues for Phase I, II, and III clinical trial studies. Conducted signal generation with clinical, medical affairs, regulatory affairs, and post-market surveillance utilizing TrackWise.

Presented product complaint information, OOS, and non-conforming events, if appropriate, to the responsible individuals at service providers. Supported selection and implementation of a global electronic Quality Management System (eQMS). Reviewed and approved Quality Agreements.

Managed quality issues, including field alerts, recalls, or other regulatory actions.

Participated in the Investigational New Drug program (IND), Pre-Approval Inspection (PAI), New Drug Application (NDA), and Biologic License Application (BLA) process.

08/2014 – 01/2015 Thermo Fisher Scientific, Fair Lawn, NJ USA

Interim Director of Quality and Regulatory Affairs Consultant

Oversee the development and deployment of Quality Management Systems (QMS) at this Global Chemicals location. Ensured the transition of the business unit’s Quality Management System and manufacturing operations from ISO 9001:2008 to being certified to ISO13485 and GMP compliance. Performed verification of documented systems that comply with all regulatory standards and agency authorities’ requirements to which Global Chemicals is accountable. Completed GAP assessment according to cGMP 21 CFR 820, ISO 13485, and ISO 14971 for FDA requirements and ISO Certification.

Responsible for all Regulatory Affairs activities, including promotional review of marketing materials and product labeling to FDA and USP requirements for the US and EU. Provided regulatory oversight and advice regarding advertising and promotional materials.

Performed Internal Audits for the quality system to determine regulatory gaps for GCP, GLP, ICH, and GMP regulations and guidelines. Qualified with QA/QC, RA, material handling, and safety of chemicals for packaging and distribution of bottles, barrels, and railroad tanker shipments and deliveries. Developed remediation plans to meet FDA and ISO requirements. Assured compliance with 21 CFR 210/211. Provided review and approval of product label proofs and issuance of labels and interacted with sourcing leaders as required to establish the expected supplier performance management qualifications.

Responsible for adherence to all applicable standards related to FDA-registered medical devices and USP Compendia products.

03/2014 – 6/2014 Novo Nordisk, (Biotechnology)Chartres, France

Project Manager, Quality Compliance and Validation

Ensured project requirements and business processes were identified and documented, and methodology deliverable timelines were met. Utilized Quality by Design for the development processing of their products for this new facility. Organized, scheduled, and managed infrastructure, production, and lab (LIMS) equipment validation activities with a cross-functional team. This position’s other responsibilities include protocol generation, Agile project management tools, protocol execution, and final summary report. Ensured project requirements and business processes were identified, documented, and deliverable methodology timelines were met—utilized Quality by Design to develop their products for this new facility.

Project manager of staff and equipment validation activities related to Novo Nordisk biologic/small-molecule Drug Substance and Drug Products, specifically in the aseptic and formulation environment. Review the CAPA Management process to streamline closures.

Led and represented validation in multi-departmental meetings and project teams to identify and implement improvements to the QA Equipment Validation systems (department-level impact). Determined QA metrics on validation deviations and non-conformance.

Provided regulatory guidance for Manufacturing, Change Control, Process Development, and QMS system. Utilized MS Project and Agile/Waterfall methodologies.

Reviewed IQ, OQ, and PQ protocols for accuracy and content.

Sterile Manufacturing

01/2014 – 03/2014 Otsuka Pharmaceuticals, Rockville, MD USA

Senior Consultant, IT Compliance Audits

Conducted complex technical audits and SOX controls testing, including data security and access control; business and disaster recovery; program change management; internal and external networks and communications; and physical security.

Performed information technology audits, application control reviews, and Sarbanes-Oxley (SOX) control testing.

Prepared audit programs, conducted risk evaluations, devised/performed tests of controls, and prepared audit reports of findings and related recommendations.

Verified operation efficiency, effectiveness, reliability, and compliance with applicable laws and regulations. Communicated findings, advised and recommended control improvements, and quality oversight to senior management.

Documented audit work using automated audit management tools and followed up on corrective actions.

05/2013 – 11/2013 Hospira Inc., (Biotechnology) Chennai, India

Senior Consultant, Manufacturing Quality Assurance Management

Provided cGMP oversight in a QA capacity for the entire manufacturing process of Bulk API formulation to finishing of a sterile fill/aseptic pharmaceutical manufacturer. Assuring documentation requirements are met, initiating appropriate investigation activities, 483 warning remediation, developing quality improvement metrics, staff coaching/training, and resolving problems when manufacturing deviations occur. Reviewed the production change control process: monitored solution prep, terminal sterilization, aseptic fill, isolator fill, and finishing/packaging processes. Oversee sterile filling for bottle/vial and syringe finished product manufacturing, batch record review, environmental monitoring, facilities maintenance, materials handling, and validation per regulatory and site requirements.

Provided Sterile Manufacturing Quality oversite. Provided independent review of original test data for existing API batches manufactured for conformance with product specifications for batch certification. Summarize findings and give recommendations for remediation. Met compliance requirements for 21 CFR 210, 211

Reviewed any major incidents/deviations identified in batch records and assessed incident/deviation potential impact on product quality. Participate in reducing lag time in conducting proper deviation investigations and CAPA implementation.

Managing production change management to ensure proper change implementation of equipment, procedures, batch records, and policies. Reviewed incidents/deviations and lowered the occurrence rate through embedded QA expertise on the manufacturing floor.

Responsible for training/mentoring permanent staff on cGMP and Aseptic practices/techniques and Data integrity. Responsible for Batch Records review and product release.

10/2012 – 05/2013 Johnson & Johnson (Synthes), Mezzovico, Switzerland

Senior Consultant, Compliance, Complaints, and Quality Assurance

Processing and remediation of customer complaints for Class II and III Medical Devices (Implantable spinal and Cranio-Maxillofacial devices) and maintaining complaint file responses to customer reports. This includes evaluating/performing investigations, 483 warning remediation, CAPA, OOS, DMR, pFMEA and Non-conformances, Medical Device Reports, Field Actions/Field Alert Reports, and supporting product platform teams. Organized test methods for process validation requirements for CNC machinery. Met compliance requirements for ISO 13485 and 21 CFR 820. Organized test methods for process validation requirements for CNC machinery.

Implemented and followed procedures to ensure timely and accurate receipt, analysis, and response to customer complaints. Reviewed all customer complaints for validity and confirmed that complaints were processed in compliance with division policies and procedures. Reviewed risk analysis reports (PFMECA’s) to verify that it was in accordance with FDA and ISO standards.

Performed organizational audits, including writing reports, creating surveys, and presenting the information to management. Maintained systems to monitor and facilitate timely investigations and closeout of open complaints. Ensured methods at workflow preclude lengthy unanswered complaints. Contributed to the business-wide quality strategy and quality objectives.

Ensured the Customer complaint root cause investigations, procedures, and activities complied with FDA Quality System Regulations, ISO, Medical Device Directives, and Vigilance. Completed FARs and remedial actions for non-conformance issues and complaints.

11/2011 – 09/2012 Hospira Inc., (Biotechnology) Rocky Mount, NC USA

Consultant, Manufacturing Quality Assurance Management

Provide cGMP oversight in a QA capacity for Bulk API’s entire CMC manufacturing process to finish a sterile fill/aseptic pharmaceutical manufacturer.

Monitored solution prep, terminal sterilization, aseptic fill, isolator fill, and finishing/packaging processes.

Overseen sterile fill for bottle/vial and syringe finished product manufacturing, batch record review, environmental monitoring, facilities maintenance, materials handling, and validation per regulatory and site requirements.

Responsible for Batch Records review and product release. Reviewed data and major deviations identified in batch records and submitted a summary of findings with management recommendations. Reviewed incidents for appropriate and timely investigation handling, corrective, and preventive action.

Participated in reducing lag time in conducting proper deviation investigations and lowering the deviation occurrence rate through embedded QA expertise on the manufacturing floor. Responsible for training/mentoring full-time staff on cGMP and Aseptic techniques.

04/2011 – 10/2011 Kimberly-Clark Corporation, Neenah, WI USA

Technical Leader, Quality Assurance Management

Overseen and facilitated Quality Systems development of OTC Drug, Cosmetic, and Medical Device manufacturing facilities for existing and new products. Audited internal quality system to determine regulatory gaps for GCP, GLP, and GMP regulations. Worked with and led global marketing teams and R&D to prepare to execute platform strategies and product launches.

Led cross-functional teams launching complex consumer technical products with a structured product development process, oversight of product development, requirements and specifications, and project schedules. Performed Supplier and Internal Audits.

Reviewed labeling and promotional/advertisement material to verify it met regulatory specifications and requirements with marketing and legal teams. Performed internal/external quality system audits and supplier qualifications to meet regulatory compliance.

Ensured that the product design requirements were defined and the resources were available in all functional departments.

Provided advice and counsel to staff and global manufacturing facilities regarding compliance with state, FDA Quality System, CGxP requirements, and international standards when necessary. Monitored quality activity to ensure seamless integration with processes and cross-functional teams R&D, RA, and P&TD. Contributed to regulatory resolution and/or quality issues and recommended corrective actions/preventive actions. Integrated plans and activities within defined policies and championed quality/regulatory policies for suppliers.

12/2010 – 04/2011 CorePharma, Middlesex, NJ USA

Program Manager, Regulatory Compliance

Worked with owners of nonconformity events to investigate and document the nonconformity in the Exception Report (ER) system. Ensured ER investigations were complete and investigated the nonconformity's root cause using investigative tools.

Worked with cross-functional areas to ensure the quality system efficiently processed CAPA plans addressing root causes. Utilized Kaizen steps to improve the process and reduce defects.

Provided ongoing support on using the CAPA system and investigation process. Worked with the users of the CAPA to ensure that the CAPA system operates effectively and complies with regulatory and corporate requirements.

Evaluated exception reports and made investigative recommendations to ensure that the reports were consistent with respect to the CAPA process. Facilitated the ER investigation process to ensure that the CAPA process was timely, identified the appropriate root cause, and implemented effective actions to reduce the occurrence/reoccurrence of non-conformance.

06/2010 – 11/2010 Johnson & Johnson (Ortho-Clinical), Raritan, NJ USA

Program Manager, Non-Conformance Resolution

Managed improvements to ensure that actions implemented met the required NIST specification for the IT Infrastructure. Documented risk, root cause analysis (RCA), and corrective/preventive actions taken.

Maintained file of product history records and reviewed change orders for discrepancies in Documentum. Utilized Track Wise to maintain CAPA compliance.

Ensured that the CAPA system was “audit ready” for internal and external quality system audits.

Responsible for managing the execution of the CAPA management process and deploying a uniform approach to corrective and preventive actions. Expedite closures of non-active non-conforming incidents and CAPAs. Utilized Documentum and versioning control.

Generated, tracked, and analyzed metrics/trends relating to non-conforming incidents and reported information to senior management.

11/2009– 06/2010 Stryker Corp, Mahwah, NJ USA

Senior Analyst, Compliance

Determined the classification, review, and disposition of adverse events and medically related complaints for marketed products, including decisions on seriousness, reportability, and potential causality.

Utilized FDA regulations for Class I, II, and III medical devices for Medical Device Reports (MDRs) and complaint handling/ reporting.

Investigated root cause, including all information related to the product, the medical procedure, the patient’s condition, and relevant risks.

Determined which complaints escalated to a Field Action or MDR/MDV report and supported MDR investigations. Trend defect/complaint data and take timely action on emerging issues. Participated in the CAPA process and system improvements.

Ensured CAPA activities were effectively coordinated across all plants/locations. Utilized cGxP requirements. Ran a weekly complaint metric analysis report and enforced timely closure of investigations/ plant engineering investigations.

07/2009 – 10/2009 Hurley Consulting Associates, Chatham, NJ USA

Senior Analyst, IT Quality/Regulatory

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