Experience

PBS Biotech, Inc.
• Director Quality Management

  • Feb 2021 - Present


ImmunityBio

• United States
• Biotechnology Research
• 300 - 400 Employee

• Sr. Manager, Quality – Document Control & Training

  • Nov 2019 - Feb 2021

  Subject Matter Expert for Document Control, Training and Computerized System Owner • Own and manage the global Document Control and Training process, procedure and QMS IT system. • Deployment of systems, including administration and oversight of the QMS IT systems, and closure/archival of legacy processes and systems. • EtQ Computertized System Owner and SME • Business Liaison between stakeholders and Global IT • Identify and implement system improvements including developing… Show more Subject Matter Expert for Document Control, Training and Computerized System Owner • Own and manage the global Document Control and Training process, procedure and QMS IT system. • Deployment of systems, including administration and oversight of the QMS IT systems, and closure/archival of legacy processes and systems. • EtQ Computertized System Owner and SME • Business Liaison between stakeholders and Global IT • Identify and implement system improvements including developing user requirements and PQ test scripts, participating in PQ testing and hypercare. • User point of contact including facilitating feedback sessions. • Develop and manage electronic and physical record document control and training strategies, processes and systems and ensure systems are maintained in a continued state of inspection readiness and in compliance with regulatory and business requirements; including support and participate as a SME during internal and external audit and health authority inspections. Show less Subject Matter Expert for Document Control, Training and Computerized System Owner • Own and manage the global Document Control and Training process, procedure and QMS IT system. • Deployment of systems, including administration and oversight of the QMS IT systems, and closure/archival of legacy processes and systems. • EtQ Computertized System Owner and SME • Business Liaison between stakeholders and Global IT • Identify and implement system improvements including developing… Show more Subject Matter Expert for Document Control, Training and Computerized System Owner • Own and manage the global Document Control and Training process, procedure and QMS IT system. • Deployment of systems, including administration and oversight of the QMS IT systems, and closure/archival of legacy processes and systems. • EtQ Computertized System Owner and SME • Business Liaison between stakeholders and Global IT • Identify and implement system improvements including developing user requirements and PQ test scripts, participating in PQ testing and hypercare. • User point of contact including facilitating feedback sessions. • Develop and manage electronic and physical record document control and training strategies, processes and systems and ensure systems are maintained in a continued state of inspection readiness and in compliance with regulatory and business requirements; including support and participate as a SME during internal and external audit and health authority inspections. Show less



Takeda

• Biotechnology
• 1 - 100 Employee

• Quality Process Owner, Manager

  • Aug 2017 - Nov 2019

  Subject Matter Expert for Quality Improvement Plans (QIPS), Change Control, Deviation & CAPA, and Computerized Systems • Owned and managed the global QIPS process, procedure and QMS IT system. • QIPS, Change Control and Deviation and CAPA: o Deployment of systems, including administration and oversight of the QMS IT systems, and closure/archival of legacy processes and systems. o QIPS, CCMS, and GEMS TrackWise 8 workflow oversight and SME o Business Liaison between systems… Show more Subject Matter Expert for Quality Improvement Plans (QIPS), Change Control, Deviation & CAPA, and Computerized Systems • Owned and managed the global QIPS process, procedure and QMS IT system. • QIPS, Change Control and Deviation and CAPA: o Deployment of systems, including administration and oversight of the QMS IT systems, and closure/archival of legacy processes and systems. o QIPS, CCMS, and GEMS TrackWise 8 workflow oversight and SME o Business Liaison between systems users, Global Process Owners and Global IT o Identified and implemented system improvements including developing user requirements and PQ test scripts, participating in PQ testing and hypercare. o User point of contact including facilitating feedback sessions. Show less Subject Matter Expert for Quality Improvement Plans (QIPS), Change Control, Deviation & CAPA, and Computerized Systems • Owned and managed the global QIPS process, procedure and QMS IT system. • QIPS, Change Control and Deviation and CAPA: o Deployment of systems, including administration and oversight of the QMS IT systems, and closure/archival of legacy processes and systems. o QIPS, CCMS, and GEMS TrackWise 8 workflow oversight and SME o Business Liaison between systems… Show more Subject Matter Expert for Quality Improvement Plans (QIPS), Change Control, Deviation & CAPA, and Computerized Systems • Owned and managed the global QIPS process, procedure and QMS IT system. • QIPS, Change Control and Deviation and CAPA: o Deployment of systems, including administration and oversight of the QMS IT systems, and closure/archival of legacy processes and systems. o QIPS, CCMS, and GEMS TrackWise 8 workflow oversight and SME o Business Liaison between systems users, Global Process Owners and Global IT o Identified and implemented system improvements including developing user requirements and PQ test scripts, participating in PQ testing and hypercare. o User point of contact including facilitating feedback sessions. Show less



Shire

• Japan
• Biotechnology Research
• 700 & Above Employee

• Quality Management Systems and Training Specialist

  • Apr 2017 - Aug 2017

  Responsible for full deployment of a transformed Quality Management System for the US sites Responsibilities included: • Managing a team of change agents in support of continued improvement in nimble and flexible quality systems. • Ensuring full and sustained deployment of newly integrated, transformed Quality Management System Elements • Ensuring compliance to regulatory requirements and driving consistency with corporate standards. • Developing and deploying strategies to… Show more Responsible for full deployment of a transformed Quality Management System for the US sites Responsibilities included: • Managing a team of change agents in support of continued improvement in nimble and flexible quality systems. • Ensuring full and sustained deployment of newly integrated, transformed Quality Management System Elements • Ensuring compliance to regulatory requirements and driving consistency with corporate standards. • Developing and deploying strategies to assure understanding of the behaviors and tactic in executing against the quality systems. • Partnering with key stakeholders, e.g. manufacturing, engineering, vigilance, regulatory, PSTO, etc. to assure the deployment of an overall effective quality system. • Continually assessing and analyzing all elements of the quality systems and recommend actions to improve them. • Managing compliance to the Global GMP Training Program.

• Quality Management Systems Transformation Change Agent

  • Sep 2015 - Mar 2017

  In addition to Documentation & Training Supervisor responsibilities: • Managed the implementation of the Quality Management System Transformation global project at the site from beginning to end. This included: • Serving as a positive advocate for change, documentation gathering, working closely with Global Process Owner and Local Process Owner to resolve discrepancies, facilitate information sessions, help develop Training Plans, manage milestone timelines, and ensure documents are… Show more In addition to Documentation & Training Supervisor responsibilities: • Managed the implementation of the Quality Management System Transformation global project at the site from beginning to end. This included: • Serving as a positive advocate for change, documentation gathering, working closely with Global Process Owner and Local Process Owner to resolve discrepancies, facilitate information sessions, help develop Training Plans, manage milestone timelines, and ensure documents are released on time for a successful Go Live. • Evaluating and analyzing data to determine whether mission objectives were met. • Success Rate – 100%.

• Documentation & Training Supervisor (02/2014 – 03/2016)

  • Feb 2014 - Mar 2016

  In addition to Documentation Supervisor responsibilities: • Responsible for overseeing the Training System for the facility. • Duties included evaluating the Training System in order to assure compliance to Divisional and Corporate procedures and policies. • Supervised staff of the Training department. • Responsible for ensuring appropriate training plan changes. • Designed, developed, implemented and delivered instructor-led training and on-the-job training. • Served as an… Show more In addition to Documentation Supervisor responsibilities: • Responsible for overseeing the Training System for the facility. • Duties included evaluating the Training System in order to assure compliance to Divisional and Corporate procedures and policies. • Supervised staff of the Training department. • Responsible for ensuring appropriate training plan changes. • Designed, developed, implemented and delivered instructor-led training and on-the-job training. • Served as an administrator for Quality Systems electronic solution (ISOtrain).

• Documentation Supervisor

  • Mar 2012 - Feb 2014

  Responsible for overseeing the Document Change Control for the facility • Duties included evaluating the Document Change Control in order to assure compliance to Divisional and Corporate procedures and policies. • Responsible for ensuring appropriate technical review and approval of all changes, MS Word processing, and document issuance. • Led ongoing daily departmental activities for areas of direct responsibility including supervision of assigned staff. • Served as an… Show more Responsible for overseeing the Document Change Control for the facility • Duties included evaluating the Document Change Control in order to assure compliance to Divisional and Corporate procedures and policies. • Responsible for ensuring appropriate technical review and approval of all changes, MS Word processing, and document issuance. • Led ongoing daily departmental activities for areas of direct responsibility including supervision of assigned staff. • Served as an administrator for Quality Systems electronic solution (Veeva Vault (previously Teamcenter)). • Responsible for trending and presentation of Quality System indicators. • Responsible for the implementation of Divisional Quality Management Systems. • Served as a subject matter expert in internal, corporate and external audits for areas of expertise.



United Blood Services

• United States
• Hospitals and Health Care
• 300 - 400 Employee

• Telerecruiter, Supervisor

  • Jun 2008 - Jan 2012

  Telerecruiter, Supervisor (06/2010 – 01/2012) Responsible for department telerecruitment activities • Performed all assigned duties in compliance with internal Standards of Practice and external regulations. • Directly supervised a team of call center agents: train and evaluate performance by conducting side-by-side monitoring, coaching, offering feedback, monitoring call quality and recruitment techniques; creating disciplinary plans as needed to develop underachieving… Show more Telerecruiter, Supervisor (06/2010 – 01/2012) Responsible for department telerecruitment activities • Performed all assigned duties in compliance with internal Standards of Practice and external regulations. • Directly supervised a team of call center agents: train and evaluate performance by conducting side-by-side monitoring, coaching, offering feedback, monitoring call quality and recruitment techniques; creating disciplinary plans as needed to develop underachieving personnel to meet the department goals and objectives in order to retain personnel and reduce turnover. • Entered customer complaints in TrackWise; researched and resolved complaints to ensure customer satisfaction. Developed and executed customer programs and incentives. Responsible for growing clientele and client retention. • Responsible for the achievement of assigned daily, monthly and yearly goals within customer demands and evaluating effectiveness of telerecruitment activities and campaigns in order to meet established goals and demands. Telerecruiter I/II (06/2008 – 06/2010) Show less Telerecruiter, Supervisor (06/2010 – 01/2012) Responsible for department telerecruitment activities • Performed all assigned duties in compliance with internal Standards of Practice and external regulations. • Directly supervised a team of call center agents: train and evaluate performance by conducting side-by-side monitoring, coaching, offering feedback, monitoring call quality and recruitment techniques; creating disciplinary plans as needed to develop underachieving… Show more Telerecruiter, Supervisor (06/2010 – 01/2012) Responsible for department telerecruitment activities • Performed all assigned duties in compliance with internal Standards of Practice and external regulations. • Directly supervised a team of call center agents: train and evaluate performance by conducting side-by-side monitoring, coaching, offering feedback, monitoring call quality and recruitment techniques; creating disciplinary plans as needed to develop underachieving personnel to meet the department goals and objectives in order to retain personnel and reduce turnover. • Entered customer complaints in TrackWise; researched and resolved complaints to ensure customer satisfaction. Developed and executed customer programs and incentives. Responsible for growing clientele and client retention. • Responsible for the achievement of assigned daily, monthly and yearly goals within customer demands and evaluating effectiveness of telerecruitment activities and campaigns in order to meet established goals and demands. Telerecruiter I/II (06/2008 – 06/2010) Show less