Motivated and results-driven business leader in organizational strategy, continuous process improvement, operational excellence, and technology. Proven experience in the pharmaceutical and biotechnology industries working in information technology, clinical data management and quality and compliance organizations. Exceptional ability to listen to senior leaders’ visions and define a strategy and action plan to deliver desired result. Global experience in leading teams on four continents, implementing global processes and technologies supporting key business functions.
Accomplished people leader with an understanding of global dynamics and cultural awareness to form cohesive, high performing teams. Known for consistent people management, treating people fairly and with respect, and embracing the unique talents and values that each individual brings to the team.
Strengths: Developing strategic plans, People leadership and development, Process improvement, Data analysis and trending, Making good business decisions, and Relationship building through partnerships and collaboration.
Focus areas: Quality management system (QMS) strategies and implementation, Learning management strategies and technologies, Procedural document lifecycle strategies and technologies, Corrective actions and preventative actions (CAPA) programs, Root cause analysis, quality and compliance risk evaluation and mitigation strategies, and inspection activities.
Vice President, R&D Quality Assurance @ Responsible for the design, development and implementation Jazz Pharmaceuticals’ quality policies, systems and procedures for all worldwide pre-clinical, clinical and drug safety operations. From April 2015 to Present (9 months) Greater Philadelphia Area(Interim) Vice President, Global R&D Quality Assurance @ Responsible for the development and implementation of the company’s Global Clinical and Pharmacovigilance Quality Assurance strategy in alignment with both business objectives and regulatory requirements.
Key activities: recruitment to fill key positions for GCP, PV and GLP quality and compliance roles, design, development and implementation of the CAPA program, improvement and implementation of the Master Audit Plan process, and change management activities related to the new CQA organization. From April 2014 to March 2015 (1 year) Senior Director @ Responsible for providing the strategic direction and leadership of the R&D Quality Operations function. Primary responsibilities include the implementation of quality systems and compliance initiatives within R&D; facilitating procedural document lifecycle management, managing system support for the QMS technologies (i.e. learning management system, auditing database, document management) and ensuring that R&D is inspection ready at all times. From November 2013 to March 2014 (5 months) Director, R&D Quality Standards & Learning @ From June 2012 to November 2013 (1 year 6 months) Director Compliance Management, Global R&D Quality Assurance @ Responsible for departmental business operations, GCP / PV vendor audit strategy, continuous improvement strategy (including process and procedural development, training and metrics) and department IT strategy. From May 2009 to June 2012 (3 years 2 months) Associate Director, Clinical Quality & Compliance (Centocor R&D) @ From March 2008 to May 2009 (1 year 3 months) Manager, Clinical Quality & Compliance (Centocor R&D) @ From September 2004 to February 2008 (3 years 6 months) Process & Training Specialist, Data Management (Centocor R&D) @ From January 2001 to November 2003 (2 years 11 months) Manager, Clinical Data Management @ From December 1996 to December 2000 (4 years 1 month) Project Manager @ From June 1996 to December 1996 (7 months) Administrator @ From February 1994 to June 1996 (2 years 5 months)
MA, Psychology @ University of the Rockies From 2009 to 2013 Bachelor of Arts, Organizational Leadership @ Eastern University From 1997 to 2001 Patricia Moore is skilled in: Training, GCP, Strategy, Clinical Research, Sop, Clinical Data Management, FDA, Data Management, Healthcare, Quality Assurance, Management, Pharmaceutical Industry, Lifesciences, Clinical Development, 21 CFR Part 11