Experience

Eidos Therapeutics
• United States
• Biotechnology
• 1 - 100 Employee
• Director, Clinical Quality Assurance

  • Nov 2021 - Present


Vertex Pharmaceuticals

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Director, Clinical QA - Cell and Gene Therapy

  • Aug 2019 - Oct 2021

  Responsible for the oversight and management of GCP quality activities related to clinical trial execution of Vertex cell and gene therapy programs:--Provide strategic GCP leadership and quality guidance, interpretation, and oversight on regulations, standards and quality systems to cross functional study teams--Drive process improvement and provide expertise and consultative guidance on business initiatives involving GCP systems, processes, and tools--Provide subject matter expertise for the enhancement and execution of the GCP Quality Management System--Responsible for assessing GCP compliance risk areas, and developing and implementing risk mitigation measures, as a core member of the Integrated Risk Governance Teams for assigned programs--Develop and lead inspection readiness activities for assigned programs--Develop, maintain, and execute strategic Audit Plans for assigned programs--Participate in the evaluation and selection of GCP service providers--Responsible for triaging, reviewing and approving Quality Issue investigations and CAPAs Show less

• Sr. Quality Manager, Clinical QA

  • Aug 2015 - Aug 2019

  -Serve as Clinical Quality Assurance Lead for clinical programs, with responsibility for providing GCP compliance oversight oversight, guidance, consultation, and training to cross functional teams-Conduct Global audits of Clinical Investigators and Phase I Clinical Research Units, and GCP documents to ensure compliance with regulatory requirements-Ensure adequate and timely review and closure of audit responses and CAPAs with supporting documented evidence in accordance with company processes-Participate in investigations into scientific misconduct and/ or serious breach of GCP, analyze investigational findings to identify root cause, and oversee the implementation of appropriate CAPAs-Provide support for regulatory inspections held at Vertex facilities and Clinical Investigator sites Show less

• Quality Manager, GCP QA

  • May 2014 - Aug 2015

  -Participated in the development, implementation, and oversight of quality activities, including vendor qualifications, in support of GCP studies conducted or monitored by Vertex-Represented GCP QA compliance on study teams to ensure compliance with regulatory requirements-Provided GCP Quality oversight and feedback to internal departments and stakeholders in the form of SOP reviews, attendance and participation in study team meetings, and ad hoc requests-Assisted in the implementation of a Document Management System for the management of event investigations and compliance audits Show less

• Quality Lead, GLP-QAU

  • Feb 2013 - May 2014

  -Served as the GLP Quality representative on the Inspections and Audit Management, and Vendor Management compliance assessment teams, with the primary objective to harmonize the inspection and audit process, and vendor management process, across GLP, GCP, GMP, and GVP departments-Oversaw the completion, summary, and presentation to management of a cross functional GLP compliance analysis-Conducted bioanalytical data and report audits in support of Pre-Clinical and Clinical studies-Supported the Bioanalytical laboratory and Biorepository relocations and re-qualification activities Show less



Acceleron Pharma

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior QA Specialist, GLP

  • Sep 2008 - Nov 2012

  -Conducted a Gap analysis of the GLP program, and developed plans to increase compliance for all areas supporting the toxicology program -Worked extensively with the Pre-Clinical Safety, Bioanalytical Development, Quality Control, and Process Development departments to ensure activities supporting the toxicology program were conducted per applicable GLP regulations -QA representative for the Pre-Clinical team; provided audit updates to assist in establishing new, and reviewing existing, timelines for completion of toxicology studies -Coordinated the scheduling and prioritization of QA audits to meet Pre-Clinical team goals, including establishing audit lead times -Conducted compliance audits and reviews of Bioanalytical, Dose Concentration, and Pharmacokinetic analyses for toxicology studies and assay validations -Developed and delivered GLP training to technical staff and Management -Communicated regulatory updates and industry trends to technical staff and Management -Managed the tasks and responsibilities for QA staff assisting with the completion of GLP study audits to meet accelerated timelines -Assisted in the validation, implementation, and deployment of an electronic Document Management System, and the first electronic deviation form -Conducted GLP qualification and study compliance audits of contract laboratories -Established communications between the QA department and contract laboratories -Supported the Document Control and GMP compliance programs -Conducted QA review of GCP Standard Operating Procedures Show less



Battelle

• United States
• Research Services
• 700 & Above Employee

• Quality Assurance Officer

  • Nov 1999 - Aug 2008

  -Ensured quality and compliance for projects across multiple technical disciplines, oversaw regulatory discussions during planning meetings, and ensured study protocols complied with FDA GLP regulations and OECD guidelines -Coordinated a sponsor inspection of the laboratory and Quality Assurance program (including document preparation and facility tour), and assisted in the preparation of the inspection report response -Assisted with the preparation of requested documents for an FDA inspection -Assessed the GLP compliance of an internally developed program for test article tracking -Regularly debriefed management on audit results and regulatory trends, leading to process improvements and decreased error rates -Conducted GLP audits of study phases, data, and final study reports -Trained QA staff on inspecting, auditing, and SOP review; expanded the effectiveness and consistency in conducting audits by implementing audit checklists into the audit training program -Prepared cost estimates for QA study activities and ensured task completion within budget Show less