Cynthia N. Brysch Cqa Qmd Email & Phone Number

Raleigh, Nc, Us

Las Vegas, Nevada, Us

Dublin, Ireland, Ie

• International quality assurance and regulatory affairs program lead responsible for technical review, authoring, assembly and management of Clinical, Pre-Clinical and Non-Clinical compliance infrastructures for lead program• Accountable for evaluating, conducting due diligence, and integrating quality systems, serving as the liaison for the corporate acquisition between Amgen and Horizon.• Ensure the global regulatory strategy and framework is consistent with business objectives and current regulatory statutes• Responsible for achieving deliverables and milestones, including authority interactions, with specific oversight of the J-NDA program• Establish cross-functional workflows with internal and external stakeholders• Execute assessments and oversee remediation processes, functions, teams and interfaces • Develop and implement program management mechanisms necessary to ensure proper implementation and maintenance of cross-functional responsibilities in partnership with key functional areas• Formulate and manage project plans and timelines to ensure assigned asset projects are appropriately prioritized and key goals are met on time• Conceive, create and implement continuous improvement of existing department processes and strategies, providing recommendations in area of expertise• Lead integration and implementation of processes• Determine key milestones and decision points with consideration of regulatory objectives, hurdles, risks and the global landscape of the asset market• Establish precedents to which characterize and mitigate risks• Develop standard reports and dashboards for trending analysis of data quality and program performance • Serve as primary point-of-contact for international RA escalation and resolution of issues• Identify, assess, and implement third-party and affiliate technologies and services• Subject Matter Expert (SME) in all aspects of International Regulatory Affairs, Quality Assurance, Program Management and Compliance

Cambridge, Ma, Us

• Principal Consultant acting as interim Senior Executive Director, R&CD QA, responsible for all non-clinical and clinical activities for Gene Therapy Center of Excellence (GTCOE) and Translational Sciences• Consultative executive expert responsible for the enhancement of corporate global quality infrastructures, programmatic strategies and drivers to compliance, efficiency and efficacy reflective of risk, impact and assets to achieve objectives • Lead development and oversight of functional responsibilities, GxP management and optimize QMS infrastructure• Principal consultative body to the provisions, interpretation, and requirements of global regulations, standards, and guidance• Assess corporate organizational compliance and responsible for developing and deploying programmatic solutions with well articulated deal principals • Communicate critical risks with diplomatic and objective representation of issue(s) in senior consultative leadership capacity • Authority in quality architectures, risk-based approaches, integrated quality metrics, data integrity drivers and deploy essential tenets to purport evidentiary state of control and data validity • Develop and establish QAU responsibilities, facility management, validation, analytical, bioanalytical and toxicology programs• Direct and deploy workflows, system requirements, validation and training programs• Execute mock inspections codified under international statutes, standards and guidance (FDA, EMA, MHRA, OECD, ICH, WHO, MHLW, CAP/CLIA, JACIE/FACT, USDA, ISO, CLSI, NIST, etc.)• Develop strong, effective working relationships with internal and external stakeholders to achieve compliance, quality, operative and corporate objectives

Greenville, Sc, Us

• Served as Principal for Department of Cell Biology and Anatomy• Supported research on mechanical loads transduced from extra-cellular space acting on intra-cellular signaling cascades that influence gene expression and temporal tissue structure• Conceive engineering approaches of PI’s Translational Biomechanics Laboratory (TBL) seeking to elucidate how mechanical signals can be manipulated to control behavior of cardiovascular tissues• Provide theoretical, mathematical and other approaches to support research endeavors via ex-tensive experimental verification and clinical correlations• Support PI research in the areas of aortic aneurysm repair, targeted therapeutic biomaterials, vascular growth and remodeling, hemodynamics, long-term mechanical support therapy, athero-sclerosis, cardiovascular birth defects, 3D tissue engineering, regenerative medicine, coronary artery bypass alternatives and extra-cellular matrix biology• Acting liaison for R&D products derived from academia with the intention of entrance to industry

Boston, Ma, Us

• Clinical quality assurance lead (GCP) and principal overseeing all Vertex global Cell and Gene Therapy (VCGT) programs • Acted as CQA VCGT head and study team lead for phase 1-3 studies focused on mutations and genes known to cause debilitating diseases • Oversaw and managed clinical target validation through human genetics, including any and all activities outsourced and/or transferred to affiliate partners• Operationalized compliance strategies by deploying programmatic solutions in a cross-functional and collaborative manner • Ensured compliance to GxPs, its reflection on product life-cycles and the means to achieve compliance from both a quality and operational vantage • Established foundational quality systems using phase gate/risk-based approaches tailored to the unique requirements of each study program • Established and acted as liaison with cross-functional teams • Developed and implemented strategic study design mechanics grounded in quality based infrastructures • Oversaw exploratory research and instituted quality standards • Developed translational study extensions to support and expand drug/device therapeutic indications • Led global protocol development and amendment necessities as lead QA reviewer• Oversaw quality events, CAPAs and effectiveness checks using risk-based and quantitative, metric-based strategies• Supported all efforts for VCGT CQA operations from concept to commercialization • Enhanced inspection readiness efforts, quality event management, and operational oversight programs• Collaborated with biostatistics, biomarkers, medical writing, medical monitoring, project management, pharmacovigilance (PV) and manufacturing functional areas

Hong Kong, Hong Kong Island, Hk

• Led all facets of quality assurance and regulatory affairs across non-clinical, pre-clinical (GLP), clinical (GCP), manufacturing (cGMP) and commercial products• Served as principal consultant for sponsors including Vertex Pharmaceuticals, Beigene, CRISPR Therapeutics and Merck• Developed tailored QA/regulatory affairs solutions for various clients in accordance with applicable local, national and international statutes, standards and guidance • Instituted the means to operationalize compliance strategies from a quality and operational vantage• Provided strategic solutions for various sponsors that traverses the entire GxP arena by employing first-to-market solutions to the challenges sponsors face whilst mitigating the ones in the future• Executed gap assessments, audits, clinical QA, quality/regulatory affairs, PV, medical writing, Protocol development, change control, design control, QMS development/assessment, training, remediation, risk management, validation and provided strategic due diligence for company assets • Provided international certification and licensure services for JACIE-FACT, CAP, ISO 13485:2016, and ISO 9001:2015• Executed global marking authorizations for IND, IDE, IVD, NDA, ANDA, 510(k), PMA, BLA and CDx submissions

Tustin, Ca, Us

• Develop strategic partnerships to solve the complexities of the life science industry by providing tailored expertise with the time and resources necessary to mitigate the challenges sponsors face with expertly sourced solutions• Ensure high levels of quality are maintained to meet and exceed client expectations • Drive organizational initiatives in a busy, fast-paced environment, and communicate effectively with executive leaders, partners and customers• Lead interactions with client stakeholders in the provision of a full range of services supporting the biopharmaceutical, pharmaceutical and medical device industries• Support business development efforts and institute initiatives to expand the market presence of the consultancy and staff augmentation services offered by PTS Advance Life Sciences • Executive Subject Matter Expert responsible for the screening, engagement and retention of industry professionals• Enhance and mature the vision for corporate quality consultancy as an emerging leader in the life science consultancy and staff augmentation industry • Key strategic driver in integrating, overseeing, executing, and delivering tactical services • Oversee and institute quality and regulatory infrastructure engagements • Senior leader collaborating with all key business components of PTS and clients • Drive QBD initiatives into client portfolios to which traverse all phases of product development from a scientific, operative, quality and regulatory vantage• Develop best in class programs for the services offered by PTS life science division • Develop standards of performance, evaluate KPIs, and initiate optimization mechanisms in both a consultancy and internal independent support capacity

• Senior Executive Management, Head of QA/RA and board member overseeing 7 global companies • Led all initiatives and employed corporate services serving sponsors from bench to bedside.• Oversaw and led all internal external compliance for sponsor therapeutic indications with precision medicines, including but not limited to immuno-oncology and genomic medicines; cell and gene therapies and acted as a corporate SME for sponsor CDx and biopharma pipelines for immuno-oncology, hematology and solid tumors; • QA/RA expert for biopharma and diagnostic services; ensured compliance with regulatory requirements, contractual agreements, and procedural documents established between sponsor and laboratory; provided executive oversight for all corporate analytical operations, facilities, systems, records and personnel; acted as international regulatory affairs expert for sponsor CDx development; ensured relative state of compliance was maintained at all corporate sites and served as host for internal and external audits; maintained accreditation of laboratory and biorepository facilities with the College of American Pathologists (CAP); oversaw facilities, operations and personnel to ensure compliance to national and international statutes; acted as corporate liaison to clients; established operative Key Performance Indicators (KPIs) and oversaw metrics to ensure organization maintained a state of control; ensured departments operated in accordance with pre-established thresholds; represented QA/RA department in all management meetings and partnered with board of directors as executive quality and regulatory affairs representative; designed and optimized corporate QMS; led internal training programs; supported corporate acquisition activities; oversaw CAPA program; identified and led areas of continuous improvement; conducted gap assessments and risk impact analysis; • Remediated critical findings and determined novel ways to alleviate budgetary constraints.

Boston, Ma, Us

• Consulted on the execution of GxP audits and quality QMS optimization consulting services for transformative gene based medicinal products (Lentiviral and AAV)• Conducted vendor qualification audits and optimized related internal QMS elements associated to such (SOPs, Forms, Work Instructions, Quality Agreements, Contracts, and processes).

San Diego, California, Us

• Developed, led and maintained QA function for oncology firm dedicated to the diagnosis and prophylaxis of AML• Conducted product development operations and provided executive regulatory affairs services to which included being a direct liaison responsible for the coordination of multi-site, multi-national agencies• Established risk management inputs and oversaw effective solutions with proven track record of business enhancement • Oversaw quality incident management program and conducted critical CAPA and Remediation operations • Developed and directly managed the Quality Management System including, but not limited to, the development and implementation of QMS policies, procedures, manuals, forms and systems• Conducted remediation operations in executive management capacity including providing suggested course of regulatory actions• Acted as liaison between organization and agencies for reconciliation efforts associated with events of critical impact as well as business strategies affecting corporate pipelines • Subject Matter Expert supporting the development of drug substance and drug products• Materials scientist evaluating API and formulational chemistry• Executive representative accompanying CEO and VP on board and third party meetings• Established relationships with affiliates to increase market presence and enhance business valueSpecific Accomplishments: Established eTMF indexes and oversaw document/data migration activities in accordance with ICH E6 (R2); Developed training program and directed internal and external contracted staff and vendors; Conducted national and international vendor, site, and product audits as senior corporate quality representative; Provided overall support in all GxP and critical to compliance market strategies; Successfuly lifted FDA clinical hold on 2 phase II trials via root cause investigation/GAP assessment and strategies to remediate findings resultant of such

Deerfield, Illinois, Us

• Partnered with a variety of organizations at various stages in the product pipeline to provide total quality management system expertise and consultation from concept to commercialization• Provided expertise in national and international regulations (GLP, cGMP, GMP, GCP)• Responsible for planning and conducting audits and other consulting services (gap assessments/analysis, inspection preparation, Standard Operating Procedure (SOP) development, validation, Quality Management Systems consulting, remediation consulting, continuous improvement and establishing critical paths for our client organizations regulated in the biotech, pharmaceutical and medical device industry. • Leveraged experience as a published scientist to extend subject matter expertise and consulting services in materials science, pharmacology, pharmacokinetics, biostatistics, biomanufacturing, bioinformatics, CMC, analytical method validation/Design of Experiments (DoE), design control, device development, toxicology, stability, pharmacovigilance (PV), product characterization, facility and equipment qualification, clinical and medical monitoring, and laboratory studies (discovery, non-clinical, GLP/CAP/CLIA)• Provided overall program management in QA, QC, PM and regulatory affairs

Geneva, Switzerland, Ch

• Executive manager of quality engineering operations • Oversaw contract supply chain services including OEM component manufacturing, kit assembly, ethylene oxide (EtO) sterilization, climate controlled warehousing and global distribution.• Maintained performance of the site’s Quality System and Quality Control processes in achieving all established customer requirements and all applicable regulatory agency requirements.• Ensured compliance with all established Corporate Quality System procedures, collaborated with customers to establish product quality requirements and develop customer compliance strategies.• Senior liaison between the company and various governmental agencies and notified bodies to assure compliance to all quality and regulatory standards.• Conducted quality system maintenance, root cause analysis, failure mode and effect analysis (FMEA), environmental and health assessments, product failure investigations, statistical product/process trending and associated MDR project management, corrective and preventative action designation, mitigation, management, and closure for process/product related concerns.• Lead production supervisor interfacing to assure effective, efficient and compliant product process realization and transfer to production operations per device specifications, drawings, user requirements and required compliance mechanisms as delineated per national/international regulations• Designed, implemented and validated process/product specifications (DQ, IQ, OQ, PQ), QC inspection processes and QA/QC procedures. •Designed or specified inspection and testing mechanisms and equipment.•Analyzed production limitations and standards.•Recommended revision of specifications when indicated.•Developed the economics of any quality control program as required.

Sugar Land, Texas, Us

• Provided regulatory compliance assurance to Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) by auditing studies, reviewing/writing protocols, reviewing/writing Standard Operating Procedures (SOPs), reviewing/writing master schedule/file documentation, advising study directors, developing quality management systems, continuously improving processes and documentation practices and interacting with sponsors and regulatory agencies.• Ensured the integrity of organizational processes and products by developing, integrating, improving and maintaining environmental and documentation controls. • Improved efficacy, efficiency, adequacy and validity of procedures, logistics, and corrective and preventative actions and/or measures via re-verification, statistical analysis, risk assessments & mitigation, and compliance qualification.• Developed, wrote, implemented and validated organizational services procured for various processes and products via quality documentation management & conducting quantitative analytics including but not limited to: toxicology, pathogenicity, infectivity, stability, solubility, corrositivity, purity, mortality, efficacy, potency, statistics, regulatory compliance certification, personnel and equipment qualification, calibration, validation, process survey forms, and regulatory submission data evaluation reports for product assays contracted at various phases of product life cycles for local, state, national and international regulatory submissions. • Developed access database system for tracking, archiving, and securing confidentiality of contracted services. • Developed, implemented, and verified validation procedures including but not limited to instillation qualification, operational qualification, design qualification, and personnel qualification according to 21CFR11.

Sugar Land, Texas, Us

• Provided GLP/GCP regulatory compliance monitoring for regulated assays through inspection and audit practices, protocol review, Standard Operating Procedures (SOPs), advising principle investigators/study directors, and interacting with sponsors and regulatory agencies.• Conducted regulatory training classes, hosted regulatory and sponsor inspections, and assessed subcontractor compliance• QA/QC for Pre-clinical, Clinical, And Product Registration assays • Carried out report and data audits, facility inspections, and in-process inspections for compliance with Good Laboratory Practices (EPA, FDA, OECD, and Japanese MAFF), National Pollutant Discharge Elimination System (NPDES) under the Clean Water Act, Texas Pollutant Discharge Elimination System (TPDES), Resource Conservation and Recovery Act (RCRA), Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), International regulations for EU, OSPAR, etc.

Houston, Tx, Us

PUBLICATIONSBrysch CN, Paterson R, Olivares O, Eberth JF, Robles-Hernandez FC, “Chitosan and Chitosan Composites Reinforced with Carbon Nanostructures,”Journal of Alloys and Compounds (July 2013)

• Developed and published analysis on multifunctional bio-composites of chitosan reinforced with carbon nano structures• Oversaw graduate and undergraduate student research• Contributed to PI grant proposals and scientific publications• Managed translational biomechanics and materials science laboratories • Ensured facility was maintained to applicable requirements (BSL 2) •Developed chitosan based bioadhesives for biomedical applications •Conceived biomedical derivative nanoparticles •GLP study director responsible for the conduct of research regarding chitosan scaffolding and it’s reflection on directed tissue regeneration applications

• Researched cardiovascular tissue response and conditioning trends in diseased and normal populations as a function of translational biomechanics, pharmacological response, biochemistry, genetics and cellular expression systems• Evaluated the pharmaceutical efficacy of current first line therapeutics in animal models as a function of disease progression, structural integrity and signaling pathology• Evaluated the influence of angiotensin receptor blockade and direct renin inhibition on the regenerative histoarchitecture, geometry, and overall biaxial-mechanical properties of the pulmonary artery and aorta• Maintained facility and equipment controls• Developed biomechanical assays and standard operating procedures for mammalian test systems\specimens• Analyzed and prepared budgets, reports, and bi-annual assessments of laboratory facilities and processes.• Provided safety, regulatory and technical training for personnel and maintained control and compliance.•Managed all laboratories, student researchers and coursesRESEARCH FELLOWSHIP:• American Heart Association-Pharmacodynamics of Angiotensin Receptor Blocker, Direct Renin Inhibitor on vasculature in Mouse Model of Marfan Syndrome. Brysch CN(PI) (Feb. 2011) RESEARCH PROPOSALS:• National Marfan Foundation-Fatigue and Fragmentation of Aortic Elastic Fibers in Marfan Syndrome. Eberth JF (PI) Brysch CN (Aug. 2011-Aug. 2012)• Pifzer- Preservation/Regeneration of Pulmonary Artery and Aortic Microstructure in Cardiovascular Disease using an Angiotensin-II Receptor Antagonist and Direct Renin Inhibition. Eberth JF (PI) Brysch CN (Aug. 2011-Aug. 2010)• Brysch CN, Eberth JF, “Prosposed Study: Treatment of Marfan Syndrome Using Angiotensin Receptor Blocker and Direct Renin Inhibitor,” International Society for Pharmaceutical Engineering, (2011)• NJ Gyen, Brysch CN, Eberth JF, “Biomimetic Polymers and Functionalization Methods,” The University of Houston (2012)

• Conducted research for the University of Houston, Center for Life Science Technology, department of Biotechnology with emphasis in biomanufacturing and bioinformatics• Identified, procured, and engineered agrobacterium possessing naturally derived pesticide resistance to methyl parathion and paraxon• Isolated, purified, and genetically modified organophosphate genes of interest• Evaluated genetic recombinant engineering applications to provide independent bacterial acquisition of genetic trait of interest• Evaluated and optimized bacterial growth environment and nutrient influence as a function of controlling variable response on recombinant protein concentration and expression• Defined bioreactor settings and nutrient addition rates required for optimal up-stream and down stream processing.• EvaluatedBioFlo 1000 bioreactor conditional influence on expression, concentration, and reaction kinetics of organophosphorus hydrolase gene isolated from naturally occurring agrobacterium and cloned in E Coli/PUC 18 vector.• Inoculated growth media, carried out purification protocols, utilized micro-concentration, and determined protein concentration using Bradford assay, spectroscopy, and quantitative analytics.• Performed downstream/ upstream processes and optimized seed train processes enhance growth rate and doubling time.• Designed and carried out all experimental assays and controls usingvarious techniques, reagents, and devices including, but not limited to,AKTA prime, Mass spectroscopy, optical microscopy, ultra centrifugation, gel electrophoresis, PCR, immunoblotting, Bradford assay and HPLC.

North Bethesda, Maryland, Us

As the President of the ISPE Southern Chapter, I provided pharmaceutical industry professionals with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. PUBLICATIONS:• Journal of Pharmaceutical Engineering, C.N.Brysch1 “Treatment of Marfan Sydrome Using Angiotensin Receptor Blocker and Direct Renin Inhibitor,”2011AWARDS:• Lifetime Achievement and VIP (2011) Cambridge Registry of Distinguished Executives, Entrepreneurs and Professionals CONFERENCE PRECEEDINGS AND ABSTRACTS:• Brysch CN, “cGMPs in the 21st Century Initiative,” The Texas Life Science Conference, (Nov. 2011)• Brysch CN, “Translational Biomechanics and Pharmaceutical Response on Aorta Vasculature in Mouse Model of Marfan Syndrome,” The International Society for Pharmaceutical Engineering (May 2011)

Bachelor Of Science (B.Sc.), Biotechnology

Biochemistry And Molecular Biology