Experience

Recursion

• United States
• Biotechnology Research
• 300 - 400 Employee

• Vice President, Head of Regulatory and Quality

  • Mar 2023 - Present

• Head of Quality Assurance

  • Jul 2021 - Mar 2023

  Culture & Mindset > Establish & embed a principles-based quality philosophy that prioritizes a patient focus, sound scientific practices, integrity and regulatory compliance > Promote an owner’s mindset through perpetuating an understanding of impact & regulatory context, critical thinking, and purposeful decision-making > Foster purpose and empowerment to motivate employees in the delivery of exceptional outcomes that advance the scientific & medical landscape… Show more Culture & Mindset > Establish & embed a principles-based quality philosophy that prioritizes a patient focus, sound scientific practices, integrity and regulatory compliance > Promote an owner’s mindset through perpetuating an understanding of impact & regulatory context, critical thinking, and purposeful decision-making > Foster purpose and empowerment to motivate employees in the delivery of exceptional outcomes that advance the scientific & medical landscape Strategy & Execution > Collaborate and partner with stakeholders to assure the quality approach enables and aligns with the company strategy, corporate commitments (i.e., ESG, EAP, Transparency), and operational priorities > Scale-up quality organization to support strategic and operational priorities across all aspects of nonclinical development (GLP), clinical material manufacturing & supply (GMP), clinical development (GCP), and quality systems (GXP) > Establish cross-discipline Quality Governance to focus efforts on the most significant vulnerabilities & opportunities that impact the ability to deliver on strategic and quality priorities > Enable risks to be quickly identified, deeply understood, and appropriately acted upon by nurturing an environment where employees are engaged, empowered, and encouraged to speak up > Lead team in the design, implementation, and continuous improvement of compliant, streamlined, and fit-for-purpose processes to support ethical and compliant research, high-quality outcomes, and operational agility > Build a training program that focuses on ensuring employees have access to current, relevant, and developmental content to enable fit-for-purpose decision-making and greater impact of delivery > Implement GXP systems with risk-informed validation and controls to increase automation of quality processes and improve data integrity >Forecast, maintain, and monitor departmental resourcing plan, budget, targets, and goals in alignment with company strategy & priorities



Karuna Therapeutics

• United States
• Biotechnology
• 100 - 200 Employee

• GXP Quality Systems and Clinical QA

  • 2020 - 2021

  Head of Karuna Quality Systems (GXP) > Implemented a comprehensive, integrated Quality strategy and QMS for the organization to assure quality objectives and corporate goals are met in the development (GLP, GCP), manufacture (GMP) and distribution (GDP) of medicines. > Established a structured Quality Manual to define Karuna's Quality Framework, in alignment with ICH Q9 guidelines, which outlines the approach taken to assure quality. > Implemented strategic and robust Quality… Show more Head of Karuna Quality Systems (GXP) > Implemented a comprehensive, integrated Quality strategy and QMS for the organization to assure quality objectives and corporate goals are met in the development (GLP, GCP), manufacture (GMP) and distribution (GDP) of medicines. > Established a structured Quality Manual to define Karuna's Quality Framework, in alignment with ICH Q9 guidelines, which outlines the approach taken to assure quality. > Implemented strategic and robust Quality Management processes to support the development, manufacture and distribution of medicines, including organizational Document Control, Training, Archiving, Auditing, Vendor Oversight, Non-conformance/CAPA, and GxP Computer System Validation/Part 11-Annex 11. > Implemented computerized systems to support the execution of Quality Management processes. > Building a team to support the organization (GxP and non-GxP) with the management of critical documentation and processes. Head of Karuna Clinical Quality Assurance (GCP, PV, GCLP) > Collaborate with Clinical Development to assure adequate Sponsor oversight of clinical programs, including the implementation of an oversight framework and inclusion of risk-based decision making. > Built a QA Oversight strategy to support Phase III program, including the auditing of clinical investigator sites, QA review of critical trial processes and documentation and direct engagement with study teams. > Established a Vendor Qualification and Oversight program to assure all vendors are appropriately qualified to provide continued clinical and laboratory services. Show less Head of Karuna Quality Systems (GXP) > Implemented a comprehensive, integrated Quality strategy and QMS for the organization to assure quality objectives and corporate goals are met in the development (GLP, GCP), manufacture (GMP) and distribution (GDP) of medicines. > Established a structured Quality Manual to define Karuna's Quality Framework, in alignment with ICH Q9 guidelines, which outlines the approach taken to assure quality. > Implemented strategic and robust Quality… Show more Head of Karuna Quality Systems (GXP) > Implemented a comprehensive, integrated Quality strategy and QMS for the organization to assure quality objectives and corporate goals are met in the development (GLP, GCP), manufacture (GMP) and distribution (GDP) of medicines. > Established a structured Quality Manual to define Karuna's Quality Framework, in alignment with ICH Q9 guidelines, which outlines the approach taken to assure quality. > Implemented strategic and robust Quality Management processes to support the development, manufacture and distribution of medicines, including organizational Document Control, Training, Archiving, Auditing, Vendor Oversight, Non-conformance/CAPA, and GxP Computer System Validation/Part 11-Annex 11. > Implemented computerized systems to support the execution of Quality Management processes. > Building a team to support the organization (GxP and non-GxP) with the management of critical documentation and processes. Head of Karuna Clinical Quality Assurance (GCP, PV, GCLP) > Collaborate with Clinical Development to assure adequate Sponsor oversight of clinical programs, including the implementation of an oversight framework and inclusion of risk-based decision making. > Built a QA Oversight strategy to support Phase III program, including the auditing of clinical investigator sites, QA review of critical trial processes and documentation and direct engagement with study teams. > Established a Vendor Qualification and Oversight program to assure all vendors are appropriately qualified to provide continued clinical and laboratory services. Show less



Vertex Pharmaceuticals

• United States
• Biotechnology Research
• 700 & Above Employee

• Quality Assurance (GXP)

  • 2017 - 2020

  > Led the maturation of the Regulatory Surveillance & Engagement program to support the organization through an evolving regulatory landscape and ensure compliance and excellence across the QMS > Led the Quality Risk Management program to maintain organizational awareness and oversight of key risks across development programs > Enabled continuous improvement of the QMS by implementing comprehensive governance strategies and infrastructure, as well as maintaining insightful data… Show more > Led the maturation of the Regulatory Surveillance & Engagement program to support the organization through an evolving regulatory landscape and ensure compliance and excellence across the QMS > Led the Quality Risk Management program to maintain organizational awareness and oversight of key risks across development programs > Enabled continuous improvement of the QMS by implementing comprehensive governance strategies and infrastructure, as well as maintaining insightful data that is required to evaluate the performance of the QMS > Led the development and implementation of QMS-enabling programs in alignment with the corporate strategy and quality objectives > Developed team operating matrix to maximize output, leverage individual strengths, and meet business needs > Championed a quality consortium membership to drive industry best practices and efficiency

• Clinical Quality Assurance (GCP)

  • 2015 - 2017

  > Led the development, implementation and oversight of QA activities to improve internal compliance, inspection preparedness and readiness and CAPA/quality issue management > Collaborated with internal departments on strategies for the implementation of quality principles and GCP/GLP regulatory requirements > Managed inspections hosted by Vertex facilities and vendor/partner sites



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Clinical Research Professional

  • 2009 - 2015

  Global Functional Resourcing via Quintiles > Led continuous improvement of monitoring processes > Implemented training to increase quality of Monitor workforce > Specialized in monitoring GCP compliance with regulatory requirements and study protocols at high-risk (e.g., research-naïve and significant non-compliance) investigative sites >Maintained accountability for investigator site management and oversight from site selection through site closure >Conducted site… Show more Global Functional Resourcing via Quintiles > Led continuous improvement of monitoring processes > Implemented training to increase quality of Monitor workforce > Specialized in monitoring GCP compliance with regulatory requirements and study protocols at high-risk (e.g., research-naïve and significant non-compliance) investigative sites >Maintained accountability for investigator site management and oversight from site selection through site closure >Conducted site prospecting, qualification, selection, monitoring and closeout visits.

• Clinical Research Associate

  • 2007 - 2009

  Contract CRA via MedFocus > Conducted site visits to monitor compliance with GCP regulations, guidelines and sponsor protocols > Maintained accountability for investigator site management and oversight of the clinical trial process from site selection to site closeout > Prospected, identified, evaluated and selected clinical research sites



University of Chicago

• United States
• Higher Education
• 700 & Above Employee

• Clinical Research Coordinator

  • 2007 - 2007



RUSH University Medical Center

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Coordinator

  • 2006 - 2007