Experience

RadMD

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Chief Compliance Officer

  • Jan 2020 - Present

  Senior quality and regulatory resource at RadMD and is responsible for sponsor and agency interactions regarding quality and compliance. Responsible for all compliance activities at RadMD. Developing and enhancing quality processes to promote, facilitate and ensure compliance with all regulatory and company standards by managing internal and external compliance related activities and is responsible for regulatory planning and oversight at RadMD. Interpreting policies/regulations and monitoring the regulatory compliance landscape, assessing the impacts of regulatory changes, and evaluating organizational activities to identify and mitigate any compliance risks Senior resource for RadMD quality assurance issues, management, and planning Designing and implementing a risk-based model for continuous compliance and process improvement Senior advisor on regulatory compliance needs for clinical trials Directing and implementing policy and process modifications for regulatory compliance and developing compliance standards for RadMD projects and deliverables Providing guidance and training pertaining to regulatory compliance (e.g. GCP, GDPR, CFRs, HIPPA) Developer and champion of the RadMD quality management system Audit and inspection hosting and quality liaison for sponsor quality and regulatory discussions Oversees vendor management including the implementation of service level agreements (SLAs) Quality planning and inspection readiness EU GDPR and data protection officer Show less



Julyk Quality Consulting

• Vancouver, Washington, United States

• Quality and Compliance Consultant

  • Aug 2018 - Dec 2019

  Quality consultant specializing in process improvements, inspection readiness, regulatory awareness, and systems validation for clinical trials Quality consultant specializing in process improvements, inspection readiness, regulatory awareness, and systems validation for clinical trials



Bioclinica

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director Of Quality Assurance

  • Sep 2016 - Jul 2018

  Senior Quality Assurance resource for high-risk and high-visibility projects. Developed quality processes to promote, facilitate and ensure compliance with GCP, regulatory, and company standards including:• Evaluated and interpreted FDA regulations and policies and serving as site contact for communication with the FDA and other regulatory agencies• Provided advice and consultation on regulatory and compliance questions and issues for internal teams• Partnered with software engineering and validation teams to develop development and validation frameworks and best practices • Acted as point person for GCP regulatory inspection requests for sponsors • Performed vendor audits for high-risk vendors (US and international) and worked to develop ongoing partnerships to facilitate best practices in response to audit findings• Managed the writing, revising, reviewing and approving of Standard Operating Procedures• Provided training and guidance to staff regarding compliance and interpretation of ICH and FDA regulations and providing regulatory guidance to project management and system validation teams• Audited systems and staff competency for overall facility compliance to ICH and FDA requirements and regulationsDesigned, developed, implemented, led and managed quality assurance programs by: • Acted as Lead Quality Assurance representative for high-value, high risk projects and initiatives• Hosted audits as requested by clients and/or regulatory agencies• Oversaw and enforced quality initiatives and company-wide compliance with regulatory requirements• Developed and implemented proper document management and change control processes • Led the investigation of quality issues and implementing corrective actions; identifying departmental strengths and weaknesses Show less

• Director of Clinical Operations

  • Aug 2015 - Aug 2016

  Director of Clinical Operations and Site Lead for the Portland, Oregon office. Responsible for Bioclinica's densitometry operations, clinical quality control, and reader management teams. • Leadership and operational responsibility for ~100 team members at five sites (Portland, OR; Newark, CA; Princeton, NJ; Shanghai, CN; London, UK)• Authored and implemented Portland, OR site Center of Excellence model and plan to foster innovation, process improvement, and increased quality through process refinement, KPI identification and metrics gathering, and workflow reorganization• Developed new efficiency and tracking model for reader management team to increase reader allocation efficiency and reduce turn-around-time for imaging services• Defined and implemented improved processes for contract radiologist scheduling and invoicing• Mentored managers and leads in operational best practices and fostered cross training to increase operational capacity across sites Show less



Synarc

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of Quality and Compliance

  • Dec 2010 - Aug 2015

  Responsible for the overall management and leadership of all quality and compliance related programs and initiatives; the company’s interactions with regulatory inspection authorities and sponsor quality groups; and the development and oversight of Synarc’s Quality Management System

• Senior Manager, Software Quality Assurance

  • Nov 2009 - Dec 2010

  Managed a staff of software quality and release management engineers to improve overall software quality and documentation practices and reduce cycle time for software testing activities of in-house-developed platforms



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Quality Manager

  • Apr 2001 - Nov 2009

  Designed and implemented quality processes and procedures for in-house and COTS developed systems in a FDA-regulated environment. Devised and implemented standard operating procedures pertaining to source and version control, access, training, auditability, and data integrity. Designed and implemented quality processes and procedures for in-house and COTS developed systems in a FDA-regulated environment. Devised and implemented standard operating procedures pertaining to source and version control, access, training, auditability, and data integrity.