Experience

Ocular Therapeutix, Inc.

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Associate Director, GCP Quality Assurance

  • Jul 2021 - Present



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Associate Director / Principal Auditor

  • Jun 2014 - Jul 2021

  - Responsible for the coordination and conduct of GCP audits of clinical investigator sites, global processes, internal systems and suppliers for compliance with applicable standards, regulatory and internal requirements.- Provide guidance in the development of responses to audit observations and resulting corrective and preventive action plans.- Perform internal management reviews of audit reports prior to issuance.- Provide internal consultancy on relevant regulations, guidelines and industry best practices as needed.- Contribute to the development and update of quality assurance standard operating procedures and other procedural documents and knowledge management assets.

• Clinical Quality Assurance Associate Director

  • Jul 2011 - Jun 2014

  • Developed global Quality Management – Medicine & Regulatory (QM-M&R) audit plans for assigned projects and ensure GCP audits of clinical research activities are conducted so as to assess compliance with applicable regulations.• Managed the conduct of audits of internal BI systems and processes• Liaised with various Medicine & Drug Regulatory Affairs (DRA) clients and stakeholders to identify areas of greatest compliance risk and to obtain input regarding audit strategy (e.g. vendors, systems). Acted as a resource to others.• Provided expertise and / or leadership to local initiatives (e.g. inspection readiness) within Compliance and Quality Mangement (CQM) and cross functional teams involving GCP compliance, as assigned. Took responsibility for the teams’ milestones and deliverables. Supervise and mentor colleagues as needed.• Managed, coordinated and trained external auditors as appropiate.• Served as a US delegate for QM-M&R global meetings. Participate in regular teleconferences with QM-M&R auditors as required, as well as in expert working groups and project teams as assigned.

• Clinical Quality Assurance Manager

  • Jul 2004 - Jul 2011

  • Managed global audit programs at the project, trial and local country levels. Ensured audits were conducted for applicable assignments within the Americas region using internal and / or external auditing resources as appropriate. Served as country auditor for Canada.• Planned and conducted quality assurance audits of clinical research activities for compliance with Good Clinical Practice (GCP), applicable regulatory requirements and company SOPs, including audits of investigator sites, clinical documentation, vendors, and internal systems and processes.• Identified, evaluated, and recommended solutions to issues raised during the performance of GCP audits. Assessed adequacy of auditee(s) CAPA plan and conducted follow-up activities as needed to monitor corrective actions.• Prepared clinical investigator sites for health authority inspections.• Provided timely advice and guidance to Medicine & Drug Regulatory Affairs personnel with regard to GCP compliance of clinical research activities, providing assessment of risk where applicable.• Mentored new Clinical Quality Assurance staff; provided training on auditing procedures.• Served as US member of QM-M&R global audit group. Participated in meetings / teleconferences with ICQA colleagues and participated in ICQA working groups and projects as assigned.

• Regulatory Compliance Auditor

  • Aug 2001 - Jul 2004

  • Conducted clinical quality assurance audits of investigator sites, documentation, vendors, and internal systems and processes for compliance with GCP, applicable regulatory requirements and company SOPs.• Served as a U.S. delegate for the organization’s International Clinical Quality Assurance group. Oversaw clinical quality assurance activities in the U.S., Canada, Argentina, Brazil, Mexico, Australia and New Zealand.• Provided feedback to clinical research management regarding GCP compliance and data quality.• Prepared clinical investigator sites scheduled for health authority inspection via training in inspection readiness, as well as review of onsite documentation.• Provided consultation, interpretation, and guidance to clinical research staff on clinical quality related regulations, guidelines, and regional and global procedures, policies and standards.



Bayer Corporation

• Global Clinical Auditor

  • 1999 - 2001

  • Conducted audits of GCP activities and documents for compliance with applicable regulatory standards (FDA and ICH) and company SOPs.• Provided feedback to clinical operations and medical research management regarding GCP compliance and data quality to ensure the highest data quality leading to approvable submissions.• Liaised with clinical investigators and medical staff to ensure that study sites met FDA inspection requirements.• Participated in the development of global audit tools, which facilitated the analysis of compliance rates for audits and presentation to management.• Provided timely and current audit planning / tracking information on all assigned projects.• Provided consultation / interpretation / guidance on clinical quality related regulations, guidelines, and on regional and global procedures, policies and standards.• Trained medical staff on the clinical quality assurance audit process and related activities.• Participated in the development / review of global medical quality management policies, standards, procedures, and guidelines.Accomplishments:• Participated in the global harmonization of clinical quality assurance auditing procedures. Served on the global site audit process team which developed a global site audit process SOP, Operational Manual and related training materials.• Assisted with the reengineering of the pre-approval process for FDA IND safety reporting submissions within the Regulatory Affairs Department. Liaised with the Drug Safety Assurance Department to facilitate the transition of post-approval adverse event reporting submissions from Regulatory Affairs to Drug Safety Assurance.• Contributed to the global redesign team focused on the streamlining of expedited safety reporting.

• Assistant Clinical Compliance Specialist

  • 1998 - 1999

  Assistant Clinical Compliance Specialist (1998 – 1999)Responsibilities:• Provided regulatory surveillance of global drug safety reporting and prepared pre- and post-approval FDA drug safety submissions for all drug products.• Monitored compliance of adverse event reporting to assess timeliness of reporting and provide recommendations for process improvement.• Performed internal document audits to ensure that clinical trial documentation and methodology conformed to company policy and regulatory requirements.Accomplishments:• Streamlined the process for periodic adverse event reporting resulting in timely submissions.• Established a procedure for tracking investigator notification of IND safety reports for use in monitoring reporting compliance.