Experience

Jasper Therapeutics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Executive Director, Clinical QA

  • May 2022 - Present

  First CQA and GCP Regulatory Compliance member and Lead for start-up company- Building infrastructure around ICH/ GCP Compliance and Inspection Readiness. Company specializes in conditioning agent for stem cells to improve engraftments and reduce toxicities/ GVHD • Conducted procedural gap analysis for inspection readiness to identify “low hanging fruit” that an Inspector could readily identify and lead to a possible 483/ GCP finding • Presented results from Gap Analysis to CEO and proposed strategies to fill inspectional gaps • Conducted internal vendor qualification audit to identify and remediate gaps in study vendor qualification • Worked with study team on inspection readiness- introduced story boards as an inspection-readiness tool • Provided ongoing GCP/ ICH project-specific and ad hoc regulatory compliance consultation for project teams Show less



Cortexyme, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Executive Director Clinical QA

  • Nov 2021 - Present

  First CQA member for company and CQA and GCP Regulatory Compliance Lead- brought in to build infrastructure around ICH/ GCP Inspection Readiness. • Conducted procedural gap analysis. Identified “low hanging fruit” that an Inspector could readily identify and lead to a possible finding/ 483. Identified Policies and Procedures needed to bring study oversight into better GCP compliance • Met with Department heads to obtain “buy-in” on strategies for Procedural improvements and identify and better prioritize Policies and Procedures needed to improve GCP compliance and Inspection Readiness • Kicked-off Procedural Improvement Project initiative. Presented results from Gap Analysis and proposed strategies to fill identified inspectional gaps • Conducted vendor qualification gap analysis to identify and remediate gaps in vendor qualification • Worked with study team to ensure study story boards were up-to date and Inspection-ready post study closure • Provided ongoing GCP/ ICH project-specific and ad hoc regulatory compliance consultation for project teams Acted as GCP compliance Lead for study team during 10-day on-site FDA Investigational Site Inspection Show less



Vertex Pharmaceuticals

• United States
• Biotechnology Research
• 700 & Above Employee

• CQA Project Lead

  • Mar 2021 - Sep 2021

  Co-CQA Lead for liver programs to ensure programs are run in compliance with ICH/GCP regulations. • Conducted procedural gap analysis on ClinOps and CQA procedures in advance of procedural re-structuring • Managed and tracked Quality Events from discovery, thru CAPAs, investigations, Root Cause analysis and closure • Identified and assessed project risk, prospective (possible) and retrospective (actual) study risks from SSU thru assessment at project close • Ensured study dossiers/ story boards were up-to date and Inspection-ready post study closure • Provided ongoing GCP/ ICH project-specific and ad hoc regulatory compliance consultation for project teams • Compared risk assessment tools and procedures across company to assist efforts to streamline QRM program throughout departments • Conducted due diligence vendor qualification audit documentation review post milestone achievement in advance of project pass-down from cell and gene therapy study partner Show less



Sangamo Therapeutics, Inc.

• United States
• Biotechnology Research
• 200 - 300 Employee

• Director, Clinical Quality Assurance

  • Aug 2017 - Dec 2020

  First head of CQA and GCP Regulatory Compliance functions for Phase I/ II Biotech company. Established and led the Clinical QA and GCP Regulatory Compliance functions to ensure all clinical studies are conducted in compliance with ICH/GCP Guidance and regulations. • Conducted gap analysis of Clinical SOPs, assessing and categorizing compliance gaps. • Conducted external (vendor and site) and internal audits, both for-cause and routine, for all clinical programs. Tracked metrics on audit findings, resolutions and corrective actions. • Performed ongoing risk analyses/ranking of clinical sites and study vendors; designed and implemented risk-based and study-specific Audit Plans and compliance strategies. • Conducted Inspection Readiness activities. Identified and assessed potential inspection findings for each project/ program and assessed risks to each. • Provided ongoing GCP/ ICH project-specific and ad hoc regulatory compliance consultation for project teams. • Supported organization’s Clinical training program. Conducted Annual and ad hoc ICH/ GCP training. • Developed and implemented GCP-related quality systems. • Provided effective oversight of systems within Clinical QA and all cross-functional organizations involved in clinical research activities in collaboration with matrix team members and CRO/vendor partners. • Promoted collaboration with internal and external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines. Show less



Theravance Biopharma US, Inc.

• United States
• Biotechnology
• 100 - 200 Employee

• Sr. Manager, GCP Compliance

  • Aug 2013 - Mar 2017

  Lead GCP/ GCLP Compliance auditor, schedule, perform, report, assemble audit metrics, performed risk analysis/ ranking of audit targets, selected and trained GCP compliance auditors/ consultants, conducted remote audits, conducted SOP and QMS gap analysis, provided GCP/ ICH ad hoc consultation to project teams, trained and mentored junior auditors, drafted GCP/ GCLP training materials, drafted company's first audit manual, audited regulatory documents for NDA/ BLA/ IND submissions. Lead GCP/ GCLP Compliance auditor, schedule, perform, report, assemble audit metrics, performed risk analysis/ ranking of audit targets, selected and trained GCP compliance auditors/ consultants, conducted remote audits, conducted SOP and QMS gap analysis, provided GCP/ ICH ad hoc consultation to project teams, trained and mentored junior auditors, drafted GCP/ GCLP training materials, drafted company's first audit manual, audited regulatory documents for NDA/ BLA/ IND submissions.



Clinical Auditing Network

• Senior Auditing Specialist (Contract position)

  • Sep 2012 - Jul 2013

  Conducted Inspection Readiness activities prior to FDA Sponsor Inspections, Carried out Due Diligence of Potential Acquistion Targets in advance of company/PI acquisitions and mergers, Assisted with FDA Sponsor Audits of Pharmaceutical and Biotechnology companies preparing for FDA submissions/approvals, Trained auditing team on risk ranking and audit preparedness, Worked with Management team on responses to FDA letters, conducted GCP audits in response to specific items raised by FDA, Acted as a member of an Audit SWAT Team to perform GCP audits at priority sites for Phase III study, Identified areas of deficiency and/or potential risk, and performed risk analyses/ranking, conducted scientific due diligence assessments and gap analyses of acquisition targets, managed successful FDA inspection, managed CAPAs through resolution. Show less



Janssen, Pharmaceutical Companies of Johnson and Johnson

• Senior Clinical Trial Manager (Contract position)

  • Sep 2009 - Aug 2012

  Managed three Global Phase 3 studies in patients with mild to moderate Alzheimer’s Disease, Counducted Inspection Readiness activities in preparation for internal Sponsor Audits and Phase III BLA submission, Identified areas of deficiency and potential audit risks to the clinical trials through QC of TMF, data analyses, and QC of select plans, training documents and guidelines, Conducted Risk Ranking to identify sites for internal audits, Managed data cleanup activities around Protocol Deviations and categorization per ICH Guidelines, Identified Protocol Deviations against I/E criteria to identify enrollment variances, Assisted with in-house Sponsor audit, Worked closely with Medical Monitors and Clinical Development Team to draft/modify plans for Audit Management, Protocol Non-compliance, and Protocol Deviation resolution, conducted gap analysis in advance of BLA submission, identified potential fraud at investigator site. Show less

• Sr. GCP Auditor (Contract position)

  • Apr 2009 - Sep 2009

  Audited targeted clinical investigator sites on a Global Phase 3 study (high enrollers, previous FDA warning letter recipients, etc) in preparation for FDA site audits, Audited clinical study reports and trial master files in preparation for upcoming FDA Sponsor audits, Provided audit findings and corrective actions to Sponsor’s QA team, Tracked findings through resolution, Trained site study personnel on resolution of findings and data QC, Trained Sponsor personnel (CRAs and QA staff) and contract auditors on protocols and priority issues for site audits, conducted risk ranking and Gap Analysis. Show less



Cytokinetics

• United States
• Biotechnology Research
• 200 - 300 Employee

• Sr. Clinical Project Manager (Contract position)

  • Mar 2008 - Mar 2009

  Managed two Global Cardiovascular trials (Phase 2), Developed study-specific trackers, study metrics, and monitoring tools, Facilitated DCF resolution, query generation, query tracking, and query resolution, Conducted data cleanup after DBL in advance of co-development partnering opportunity, Reviewed, tracked and finalized Initiation Visit, Monitoring Visit, and Drug Accountability Reports, Resolved data queries, conducted data listings review on an ongoing basis, Assisted with vendor management (CRO, ECG, ETT, Echocardiogram, data management), Assisted in draft of Phase II “Lessons Learned” prior to data lock and Initiation of Phase 3 study planning, Served as primary point of contact for CRAs regarding escalated study-related issues, Acted as part of a team that was able to lock the study data 14 days after Last Patient Visit, Drafted CRF, CRF Completion Guidelines, Protocol Amendment Summary of Changes, IMP Manual, Study Plans, Managed Protocol Exceptions, Deviations and Violations Show less



Kosan Biosciences

• Biotechnology Research
• 1 - 100 Employee

• Project Manager (Contract position)

  • Sep 2006 - Feb 2008

  Managed Phase II and II/III clinical research studies for Multiple Myeloma, Led cross-functional team to achieve rapid study start-up on global Phase 2/3 and Phase 3 Trials, Managed budgets and timelines, developed and managed study-specific metrics, Drafted RFPs, reviewed vendor bids, , Managed transition from paper to electronic data capture, Identified study sites and Principal Investigators, Worked with CRO to ensure rapid site activation, Invited Key Opinion Leaders to study kickoff meeting, Conducted budget and contract negotiations, vendor selection, electronic CRF production, Served as primary point of contact for site and CRO regarding escalated study-related issues, Oversaw the completion of study materials: Protocol, Protocol Amendment, Monitoring Plan, Safety Plan, Study Reference Manual, CRFs and CRF Completion Guidelines, Monitoring Manual, SIV presentations, IM presentations, and study-specific tools., led cross-functional team of 4, conducted vendor qualification audits, drafted vendor management plan, trained/ mentored CRAs and contract auditors. Show less



Chiron Corporation

• United States
• Biotechnology
• 100 - 200 Employee

• Senior Clinical Research Associate (Contract position)

  • Apr 2005 - Sep 2006

  Managed Central IRB and Vendors for two International Cystic Fibrosis trials, Conducted study start-up activities, including regulatory document submissions and review, Assisted in identification of study sites and Principal Investigators, Drafted and ensured finalization of study-specific tools and manuals, Resolved data discrepancies, conducted data listings review, managed query resolution, Negotiated budgets and contracts, managed adherence to budgets/timelines and study-specific metrics, Managed CTMS and IVRS systems, including triggering of site activation/de-activation, Acted as primary contact for sites regarding Serious Adverse Event reporting and resolution, Developed study-specific project metrics, Managed Protocol Exceptions, Deviations and Violations, Verified that all applicable regulatory documents were on file and accurate prior to site activation and clinical supplies shipment Show less


Roche
• Switzerland
• Biotechnology Research
• 700 & Above Employee
• Clinical Trial Manager (Contract position)

  • Feb 2003 - Apr 2005

BioGenex
• Biotechnology
• 1 - 100 Employee
• Director Clinical Research

  • Oct 2001 - Feb 2003