Experience

AiCure

• United States
• Software Development
• 1 - 100 Employee

• Sr. Director, Quality Assurance

  • Jun 2021 - Present

  ● Oversees the customer and partner audit program, including: o Defining ongoing enhancements to the Customer Audit program o Managing and tracking the scheduling, preparation, hosting, and following-up for customer and partner audits o Defining the model for and deliver coaching to other departments who are actively participating in audits o Coordinating client audit responses ● Implement, maintain, and actively contribute to QA-managed programs, including: o Corrective and… Show more ● Oversees the customer and partner audit program, including: o Defining ongoing enhancements to the Customer Audit program o Managing and tracking the scheduling, preparation, hosting, and following-up for customer and partner audits o Defining the model for and deliver coaching to other departments who are actively participating in audits o Coordinating client audit responses ● Implement, maintain, and actively contribute to QA-managed programs, including: o Corrective and Preventive Action (CAPA) program o Quality System Deviation program o Supplier evaluation/audit program o Internal Quality System Audit program ● Influence the evolution of the QMS by working with the cross-functional teams on the review and update to the procedures. ● Create and maintain a viable training program and track training compliance ● Create a culture of quality and shared accountability throughout the organization and ensuring established processes are followed. ● Oversee and manages external assessments of AiCure including but not limited to ISO 27001 and SOC 2 and ensuring non-conformities are tracked and remediated. ● Manages any activities related to customer and partner regulatory inspections and internal audits ● Assist with the core product Validation activities ● Help support and track requests from Sales, Services, Legal, and other departments related to quality and regulatory requests from customers including: o RFP/RFI responses o Contract reviews (focusing on quality & regulatory requirements/adherence) ● Support requests from QA senior management related to the department’s business operations (e.g., metrics, status updates) ● Create quality-related metrics and present to leadership along with enhancements to the QMS and Quality Operations across the Organization ● Participate in the management of the ISMS and management of risk identified as part of the corporate risk assessment ● Participate in Security Incident and BC/DR testing on an annual basis

• Director, Quality Assurance

  • Feb 2021 - Jun 2021

• Associate Director Quality Assurance

  • Nov 2018 - Feb 2021



Medidata Solutions

• United States
• Software Development
• 700 & Above Employee

• Sr. Manager, Quality & Regulatory Affairs

  • Jul 2016 - Nov 2018

  The Senior Manager, Quality & Regulatory Affairs (QRA) is responsible for defining and managing business-related operations of the QRA department, including but not limited to the client audit and Quality Incident management programs. The Senior Manager, QRA interacts will all levels of management and other personnel within Medidata, as well as with auditors and other representatives from Medidata's clients and prospects. Main Duties: • Define and manage client audit program… Show more The Senior Manager, Quality & Regulatory Affairs (QRA) is responsible for defining and managing business-related operations of the QRA department, including but not limited to the client audit and Quality Incident management programs. The Senior Manager, QRA interacts will all levels of management and other personnel within Medidata, as well as with auditors and other representatives from Medidata's clients and prospects. Main Duties: • Define and manage client audit program, including: • Define ongoing enhancements to the client audit program • Define the model for and deliver coaching to other departments who are actively participating in client audits • Define and manage the coordination of audit/validation webinars • Define and contribute to QRA-managed programs, including: • Quality Incident management • Exception/Pilot • Supplier evaluation/audit • Quality System Document management • Internal Quality System audit (in coordination with department-led operational self-assessments) • Define and provide quality and regulatory training • Provide operational support to QRA management and other departments

• Manager, Quality & Regulatory Affairs Operations

  • Sep 2013 - Jul 2016

  • Oversee the customer and partner audit program, including: o Assisting QRA senior management define ongoing enhancements to the customer and partner audit program o Managing and tracking the scheduling, preparations, hosting, and following-up for customer and partner audits of Medidata, including hands-on involvement in and support for such audit-related activities o Helping QRA senior management define the model for and deliver coaching to other departments who are actively… Show more • Oversee the customer and partner audit program, including: o Assisting QRA senior management define ongoing enhancements to the customer and partner audit program o Managing and tracking the scheduling, preparations, hosting, and following-up for customer and partner audits of Medidata, including hands-on involvement in and support for such audit-related activities o Helping QRA senior management define the model for and deliver coaching to other departments who are actively participating in customer and partner audits o Helping with the design of and the coordination of audit/validation webinars o Coordinating audit responses and preparing and delivering Medidata’s audit response to external auditors • Implement, maintain, and actively contribute to QRA-managed programs, including: o Corrective and Preventive Action (CAPA) program o Quality System Deviation and Exception program o Supplier evaluation/audit program o Quality System Document Management program o Internal Quality System Audit program (in coordination with department-led operational self assessments) • Assist QRA senior management with activities related to customer and partner regulatory inspections and internal audits and regulatory inspections of Medidata itself • Help support and track requests from Sales, Services, Legal, and other departments within Medidata related to quality and regulatory requests from customers and partners, including oversight over the support and tracking provided by direct reports, including: o RFP/RFI responses o Quality and regulatory-related document requests o Services Partners Operational Reviews • Support requests from QRA management related to the department’s business operations (e.g., metrics, status updates)

• Sr. Quality & Regulatory Affairs Coordinator

  • Nov 2011 - Sep 2013

  • Support customer and partner audits, including: o Scheduling, preparing for, hosting, and following-up on customer and partner audits of Medidata o Providing coaching to other departments who are actively participating in customer and partner audits o Helping with the development and coordination of audit/validation webinars o Coordination of audit responses and the preparation and delivery of Medidata’s audit response to external auditors • Assist in providing operational… Show more • Support customer and partner audits, including: o Scheduling, preparing for, hosting, and following-up on customer and partner audits of Medidata o Providing coaching to other departments who are actively participating in customer and partner audits o Helping with the development and coordination of audit/validation webinars o Coordination of audit responses and the preparation and delivery of Medidata’s audit response to external auditors • Assist in providing operational support to QRA-managed programs, including: o Corrective and Preventive Action (CAPA) program o Quality System Deviation and Exception program o Supplier evaluation/audit program o Quality System Document Management program o Internal Quality System Audit program (in coordination with department-led operational self assessments) • Assist QRA management with activities related to customer and partner regulatory inspections and internal audits; and regulatory inspections of Medidata itself • Fulfill requests from Sales, Services, Legal, and other departments within Medidata related to quality and regulatory information and documentation for customers and partners • Fulfill requests from QRA management related to the department’s business operations (e.g., metrics, status updates)

• Senior Quality Assurance Specialist

  • Aug 2009 - Nov 2011

  •Assist the QA Director through taking a lead role in oversight of the Document Management System. •Assist the QA Director through taking a lead role in the management of the Employee Training Documentation System including the review of training matrices, updating of training matrices as needed and documenting training with other Department heads. •Assist the QA Director with the management of the Customer Complaints including confirming corrective actions and effectiveness of preventive… Show more •Assist the QA Director through taking a lead role in oversight of the Document Management System. •Assist the QA Director through taking a lead role in the management of the Employee Training Documentation System including the review of training matrices, updating of training matrices as needed and documenting training with other Department heads. •Assist the QA Director with the management of the Customer Complaints including confirming corrective actions and effectiveness of preventive actions and formal close-out as needed. •Assist the QA Director or act as Lead Auditor as part of the Internal Quality System Audit Program. •Report any deficiencies observed clearly and concisely to supervisor and Executive Management as directed. •Assist with identifying any existing system problems and work with key personnel at Medidata, Clients, and Vendors/Suppliers to implement corrective actions. •Serve as a Liaison to departments to ensure software validation and supporting documentation and information conform to applicable quality standards and applicable requirements. • Assist in conducting Quality Assurance investigations in support of unfavorable findings in data/reports/systems. • Enter adverse findings into tracking/reporting systems. • Act as Lead Auditor or assist with Client Audits. • Assist the QA Director in developing and managing the Regulatory Training Program. • Assist the QA Director with providing support for Requests for Information (RFIs)/Requests for Proposal (RFPs) (for review by QA Director prior to sending). • Serve as Lead Auditor or provide support for Supplier/Vendor Audits. • Maintain GxP compliant Archive. • Perform Quality Assurance Review and Approval of software releases (e.g., product Integrations, Configuration packages) to assure complete testing and reconciliation of defects as needed. • Perform Quality Assurance Review and Approval of executed validation test scripts to assure user requirements and functionality was tested, as needed.

• QA Specialist

  • Mar 2008 - Aug 2009

  • Perform Quality Assurance review and approval of configuration/validation packages to assure complete testing and reconciliation of defects. • Review and approve executed validation test scripts to assure user requirements and functionality has been appropriately tested. • Assist in the management of the Document Management System. • Assist in the management of the personnel Training System, including review of training matrices and updating training matrices. • Assist in the… Show more • Perform Quality Assurance review and approval of configuration/validation packages to assure complete testing and reconciliation of defects. • Review and approve executed validation test scripts to assure user requirements and functionality has been appropriately tested. • Assist in the management of the Document Management System. • Assist in the management of the personnel Training System, including review of training matrices and updating training matrices. • Assist in the management of the Corrective and Preventive Action (CAPA) system, including entering findings into tracking/reporting systems, issuing findings to appropriate personnel, confirming corrective actions and effectiveness of preventive actions and formal close-out as needed. • Perform Internal Quality System Auditing. • May be called upon to lead, perform and support client audits as needed (based on skillset and experience). • May be called upon to lead, perform and support external audits (Supplier audits) as needed, (based on skillset and experience). • Report any deficiencies observed, clearly and concisely to Quality Assurance management and Executive Management. • Assist in identifying any existing system problems and work with key personnel at Medidata, Clients and Suppliers to implement corrective actions. • Assure software validation and supporting documentation and information conform to applicable quality standards and applicable requirements. • Assist in conducting Quality Assurance investigations in support of findings in data/ reports/ systems as needed. • Perform or provide support for the Regulatory training program as needed (based on skillset and experience). • Provide support for Requests for Information (RFI) sheets.



BARC USA

• Quality Assurance

  • Sep 2004 - Mar 2008

  • Establish, implement, and maintain the quality assurance system and its procedures, required to comply with quality guidelines such as GCP, GLP, ISO and CAP, as agreed with the senior management of within the company. • Verify that all procedures and working instructions are set in compliance with the quality assurance system and the applicable quality guidelines. • Assure training of personnel concerning the quality assurance system and its procedures, HIPAA and safety guideline… Show more • Establish, implement, and maintain the quality assurance system and its procedures, required to comply with quality guidelines such as GCP, GLP, ISO and CAP, as agreed with the senior management of within the company. • Verify that all procedures and working instructions are set in compliance with the quality assurance system and the applicable quality guidelines. • Assure training of personnel concerning the quality assurance system and its procedures, HIPAA and safety guideline (OSHA) • Implement and maintain a system to record educational background, experience and training of all employees. • Organize and conduct internal and external audits • Ensure that each department implements relevant QC checks to ensure a high level quality of service • Ensure adequate tracking on source data for all laboratory data in the database system • Ensuring a full audit trail, including control over the validation of different computer systems • Ensure the proper validation of all laboratory instruments and methods used in clinical trials. Ensure global transparency of laboratory methods, results and reference ranges across different entities of the company. This includes in-house developed interlaboratory comparison programs. • Evaluate internal and external quality programs such as CAP, ISO, CDC, and NGSP. Show less • Establish, implement, and maintain the quality assurance system and its procedures, required to comply with quality guidelines such as GCP, GLP, ISO and CAP, as agreed with the senior management of within the company. • Verify that all procedures and working instructions are set in compliance with the quality assurance system and the applicable quality guidelines. • Assure training of personnel concerning the quality assurance system and its procedures, HIPAA and safety guideline… Show more • Establish, implement, and maintain the quality assurance system and its procedures, required to comply with quality guidelines such as GCP, GLP, ISO and CAP, as agreed with the senior management of within the company. • Verify that all procedures and working instructions are set in compliance with the quality assurance system and the applicable quality guidelines. • Assure training of personnel concerning the quality assurance system and its procedures, HIPAA and safety guideline (OSHA) • Implement and maintain a system to record educational background, experience and training of all employees. • Organize and conduct internal and external audits • Ensure that each department implements relevant QC checks to ensure a high level quality of service • Ensure adequate tracking on source data for all laboratory data in the database system • Ensuring a full audit trail, including control over the validation of different computer systems • Ensure the proper validation of all laboratory instruments and methods used in clinical trials. Ensure global transparency of laboratory methods, results and reference ranges across different entities of the company. This includes in-house developed interlaboratory comparison programs. • Evaluate internal and external quality programs such as CAP, ISO, CDC, and NGSP. Show less