Clinical Operations and Quality Leader GCP Compliance QMS Developm
Resume:
Summary:
A proven leader with a passion for building and empowering cross-functional teams. I believe a good leader must lead by example, provide clear direction, and most of all be a good listener with the ability to facilitate discussions, resolve issues, and align stakeholders.
Broad background specializing in:
Conduct of clinical trials to ensure compliance with FDA and EMA regulations
Strategic planning to align functional and Enterprise goals
Quality Management System development, implementation, and maintenance
Process Improvement geared towards increasing efficiency and compliance
Inspection management and preparedness
Vendor Management and auditing
Gap Assessment and remediation
Issue escalation and resolution
Risk Management
Compliance training
System Development Life Cycle (SDLC) development, implementation, and maintenance
Experience:
W.L. Gore and Associates, Inc. Nov 2016 – Present
Clinical Study Management Functional Team Leader Current positon
Key responsibilities:
Lead Continual Process Improvement initiatives within the global study management function to reduce complexity and ensure compliance with FDA and EMA regulations.
Collaborate with Clinical Quality Assurance and Global Clinical Leadership on quality initiatives to ensure compliance with FDA, EMA, and PMDA regulations, ISO 14155, and ICH GCP E6 guidelines.
Provide people leadership to Study Managers, Training Champion, and Vendor Management.
Strategic planning to align study and vendor management goals with Clinical and Enterprise goals.
Organize subject matter expertise to establish best practices in clinical study management and vendor oversight, including gap assessments, incorporation of regulatory and industry changes, SOP development and functional training.
Use project management principles to prioritize, resource, and monitor project progress.
Development, implementation, and tracking of Key Performance Indicators for vendors.
Issue escalation and resolution, including Supplier Corrective Action requests.
Deviation and CAPA investigation, resolution, and effectiveness verification.
Associate development including the creation and maintenance of competency models.
Clinical Quality Assurance July 2016 – Nov 2021
Key responsibilities:
Quality System implementation and maintenance to support the conduct of clinical trial activities in accordance with FDA, EMA, and PMDA regulations, ISO 14155, and ICH GCP E6 guidelines.
Auditing of clinical sites, vendors, and internal processes.
Inspection readiness and support.
Conduct risk assessments and identify mitigation strategies.
Deviation and CAPA investigation, resolution, and verification of effectiveness
Compliance training
Continual process improvement and cultivation of risk-based methodologies
Perficient, Inc. (formerly BioPharm Systems, Inc.) Apr 2010 – July 2016
Director of Quality Assurance Compliance-Life Sciences Jan 2013 – July 2016
Key responsibilities:
Development and implementation of a comprehensive Quality System to meet ISO 9001, ISO 13485, CFR Part 11, and ICH GCP compliance to support the implementation of computer systems and hosting of GxP data for US and EU clients.
Implementation of a risk-based Software Development Lifecycle based on GAMP 5 and agile methodologies.
Development of auditing processes for internal, client, regulatory, and vendor audits.
Development of audit team to support client, vendor, internal audits, and regulatory inspections.
Key point of contact for client audits and regulatory authorities.
Continual process improvement and cultivation of risk-based methodologies.
Development and tracking of quality metrics and audit reports for Sr. Management review.
Deviation and CAPA investigation, resolution, and verification of effectiveness.
Compliance training.
Director of Validation Apr 2010 – Jan 2013
Change Control management and implementation.
Built a successful Computer System Validation team by mentoring, coaching, and providing oversight.
Internal Auditing.
SOP development and maintenance.
Continual process improvement and cultivation of risk-based methodologies.
Amylin Pharmaceuticals, Inc. – San Diego, CA May 2007 – Apr 2010
QA Manager
Quality oversight for the implementation of computers systems supporting clinical trials.
Internal Auditing.
SOP development and maintenance.
Analysts International (Assignment Eli Lilly, Inc. – PDS Medical Device) Aug 2005 – Feb 2007
Validation Lead
Implementation of multiple IT systems in support the manufacture of medical devices.
SOP development and training.
Liaison between quality, engineers, and product teams to develop business requirements.
Audit support
Jacobs Engineering, Inc. (Assignment Eli Lilly, Inc. – Bulk Manufacturing) Apr 2003 – Feb 2005
Project Manager for simultaneous fast-tracked projects within bulk drying facilities.
Liaison between engineering, facilities, and quality to conducted and coordinated Design Reviews.
Crew Technical (Assignment Eli Lilly, Inc.- Bulk Manufacturing ) Aug 2000 – Apr 2003
Validation Lead and Project Manager for two bulk drying facilities.
SOP development and training.
Education:
Purdue University – West Lafayette, IN May 1998
BA in Communications
Phi Beta Kappa honor society
Certifications and Training:
Medfx Leadership Development Program 2022-2023
ICH E6 GCP Interactive Workshop: Supplier/Vendor/Contractor Qualification Program 2018
ICH E6 GCP Interactive Workshop: How to Build a Sponsor Risk Management Program 2018
SQA: Good Clinical Practice Understanding the basics 2017
FDA Auditing of Computerized Systems and Part 11 2007
Certified Information Systems Auditor (CISA) certification number: 15123323
ASQ- Certified Manager of Quality/Operational Excellence (CMQ/OE) certification number: 53163
Awards:
President's Award: BioPharm 2010
Peer Award: BioPharm 2011
Peer Award: BioPharm 2012
President's Award: BioPharm 2013
Peer Award: Perficient Q3 2014
Life Sciences Spot Award: Perficient Q4 2015
Extra Mile Award: Perficient Q1 2016
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