Chief Executive Officer

• Jan 2008 - Present

Responsible for overall leadership, development, and execution of client relationships and deliverables for PDC Pharma Strategy focus areas, which include corporate compliance, GxP quality systems and assurance, pharmacovigilance, and clinical development and operations. PDC Pharma Strategy is a consulting firm that develops and executes risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle, including… Show more Responsible for overall leadership, development, and execution of client relationships and deliverables for PDC Pharma Strategy focus areas, which include corporate compliance, GxP quality systems and assurance, pharmacovigilance, and clinical development and operations. PDC Pharma Strategy is a consulting firm that develops and executes risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle, including pharmaceuticals, radiopharmaceuticals, biologics, and devices. Show less Responsible for overall leadership, development, and execution of client relationships and deliverables for PDC Pharma Strategy focus areas, which include corporate compliance, GxP quality systems and assurance, pharmacovigilance, and clinical development and operations. PDC Pharma Strategy is a consulting firm that develops and executes risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle, including… Show more Responsible for overall leadership, development, and execution of client relationships and deliverables for PDC Pharma Strategy focus areas, which include corporate compliance, GxP quality systems and assurance, pharmacovigilance, and clinical development and operations. PDC Pharma Strategy is a consulting firm that develops and executes risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle, including pharmaceuticals, radiopharmaceuticals, biologics, and devices. Show less

Chief Compliance Officer | Data Protection Officer

• Dec 2020 - Present

Executive QA & Corporate Compliance Consulting Advisor | Data Protection Officer

• Jan 2021 - Oct 2023

Acting Executive Vice President Quality & Compliance | Data Protection Officer

• Jan 2023 - Sep 2023

Senior Director, Global Quality Assurance & Training

• 2011 - 2013

Responsible for evaluating all aspects of the quality system including, but not limited to, quality assurance auditing and employee training, following company growth phase. Created and executed strategy to gain efficiencies and ensure ongoing regulatory compliance, including implementation of an electronic training system. Facilitated all sponsor audits and worked with sponsors during regulatory inspections. Additionally, responsible for the company's secure file room and its clinical labeling… Show more Responsible for evaluating all aspects of the quality system including, but not limited to, quality assurance auditing and employee training, following company growth phase. Created and executed strategy to gain efficiencies and ensure ongoing regulatory compliance, including implementation of an electronic training system. Facilitated all sponsor audits and worked with sponsors during regulatory inspections. Additionally, responsible for the company's secure file room and its clinical labeling and distribution center. Show less Responsible for evaluating all aspects of the quality system including, but not limited to, quality assurance auditing and employee training, following company growth phase. Created and executed strategy to gain efficiencies and ensure ongoing regulatory compliance, including implementation of an electronic training system. Facilitated all sponsor audits and worked with sponsors during regulatory inspections. Additionally, responsible for the company's secure file room and its clinical labeling… Show more Responsible for evaluating all aspects of the quality system including, but not limited to, quality assurance auditing and employee training, following company growth phase. Created and executed strategy to gain efficiencies and ensure ongoing regulatory compliance, including implementation of an electronic training system. Facilitated all sponsor audits and worked with sponsors during regulatory inspections. Additionally, responsible for the company's secure file room and its clinical labeling and distribution center. Show less

Director, Pharmacovigilance Global Quality Management

• 2005 - 2008

Continued to oversee and continuously improve the global pharmacovigilance (PV) quality management organization within Johnson & Johnson (J&J). Upon development of the first J&J PV QA unit, ensured that global PV quality management transitioned the relevant responsibilities. Oversaw adjustments to processes for managing CAPA development, review, and status tracking to enable efficient collaboration with the newly formed PV QA unit. Further developed processes to provide all global… Show more Continued to oversee and continuously improve the global pharmacovigilance (PV) quality management organization within Johnson & Johnson (J&J). Upon development of the first J&J PV QA unit, ensured that global PV quality management transitioned the relevant responsibilities. Oversaw adjustments to processes for managing CAPA development, review, and status tracking to enable efficient collaboration with the newly formed PV QA unit. Further developed processes to provide all global pharmacovigilance information and metrics to the QPPV. Met with the QPPV monthly to review metrics and status of the global PV Quality Management system. Played key role in facilitation of three MHRA/EMEA PV regulatory inspections, and numerous FDA inspections. Received J&J Standards of Leadership Award for achieving exceptional business results through organizational development including developing and guiding high-performance teams and functioning as both team player and leader. One of five women selected to represent J&J at the 2005 Rutgers Senior Leadership Program for Professional Woman

Associate Director, Pharmacovigilance Global Quality Management

• 2002 - 2005

Developed and oversaw the first global pharmacovigilance quality management organization within Johnson & Johnson. Developed processes, hired staff, and established teams responsible for global SOP development, clinical and post-marketed expedited and aggregate report compliance monitoring, quality review of global processes, individual case processing and aggregate reports, internal CAPA monitoring and trending, and content support for regulatory and SOP training. Established and led the… Show more Developed and oversaw the first global pharmacovigilance quality management organization within Johnson & Johnson. Developed processes, hired staff, and established teams responsible for global SOP development, clinical and post-marketed expedited and aggregate report compliance monitoring, quality review of global processes, individual case processing and aggregate reports, internal CAPA monitoring and trending, and content support for regulatory and SOP training. Established and led the global pharmacovigilance SOP council. Received three J&J Vision Awards and one J&J Encore Award. Selected to represent the J&J division at the 2004 J&J/Smith College Customized Program for Women’s Leadership.

Senior Manager, Global Pharmacovigilance Quality Management

• 2000 - 2002

Brought quality management concepts and processes to the Wyeth global pharmacovigilance organization and developed their first quality management group from the ground up. Developed and implemented adverse event case quality review and quality review of DSURs and safety responses to regulatory health authority requests. Developed and implemented monitoring of clinical and post-marketed expedited adverse event and aggregate reporting compliance to all applicable local and global regulatory… Show more Brought quality management concepts and processes to the Wyeth global pharmacovigilance organization and developed their first quality management group from the ground up. Developed and implemented adverse event case quality review and quality review of DSURs and safety responses to regulatory health authority requests. Developed and implemented monitoring of clinical and post-marketed expedited adverse event and aggregate reporting compliance to all applicable local and global regulatory requirements. Show less Brought quality management concepts and processes to the Wyeth global pharmacovigilance organization and developed their first quality management group from the ground up. Developed and implemented adverse event case quality review and quality review of DSURs and safety responses to regulatory health authority requests. Developed and implemented monitoring of clinical and post-marketed expedited adverse event and aggregate reporting compliance to all applicable local and global regulatory… Show more Brought quality management concepts and processes to the Wyeth global pharmacovigilance organization and developed their first quality management group from the ground up. Developed and implemented adverse event case quality review and quality review of DSURs and safety responses to regulatory health authority requests. Developed and implemented monitoring of clinical and post-marketed expedited adverse event and aggregate reporting compliance to all applicable local and global regulatory requirements. Show less

Manager of Quality Management, Clinical Data Management

• 1998 - 2000

Drug Safety Case Quality, Pharmacoviglance

• 1997 - 1998

Manager, IND / NDA Document Quality, Regulatory Affairs

• 1996 - 1997

Regulatory Project Manager

• 1995 - 1996

GCP / GLP Auditor, Regulatory Affairs

• 1993 - 1995

Pharmacologist, Preclinical Research

• 1991 - 1993