AD, QA Validation CSV

• May 2022 - Present

Sr. Manager, Quality Systems CSV

• May 2021 - Sep 2022

Providing leadership in the development, implementation and maintenance of GxP systems at Akebia Therapeutics. Providing leadership in the development, implementation and maintenance of GxP systems at Akebia Therapeutics.

Contracting/Consulting: CSV Quality Systems, Qualification, Risk Assessments

• Oct 2017 - Apr 2021

I am a Quality Architect with solid experience in Life Sciences business engagement. Well-versed in Agile/Scrum and Waterfall methodologies, as well as, virtualization and cloud technologies. Experience with virtualization, Oracle, Compliancewire, Veeva Vault, Plateau, Sharepoint, TrackWise, iManage, Apttus, CA Agile Central, Atlassian Confluence, Jenkins, Selenium & MS Office. My focus is on business customer requirements within the regulatory industries. I am passionate about employing best-practices processes in the Life Sciences; to drive down error rates & administrative overhead, to boost productivity.

Senior QA Engineer

• Jul 2015 - Sep 2017

IaaS test plan architect; quality design, auditing and reporting ● Develop​ ​ quality​ ​ vision,​ ​ as​ ​ well​ ​ as,​ ​ roadmap​ ​ & ​ ​ strategy​ ​ for​ ​ cloud​ ​ & ​ ​ virtualization​ ​ product ● Design​, supervise​ ​ test​ ​ plans,​ ​ processes​ ​ & ​ ​ reports​ ​ for​ ​ compliance,​ ​ traceability​ ​ & ​ ​ auditability ● Drive​ ​ adoption​ ​ of​ ​ regulatory,​ ​ industry​ ​ & ​ ​ company​ ​ frameworks​ ​ (FDA,​ ​ ISO​ ​ & ​ ​ company​ ​ policy) ● Develop​ ​ & ​ ​ champion​ ​ processes​ ​ for​ ​ distributed​ ​ geographical​ ​ Agile​ ​ development​ ​ environment

QA Specialist - QA Clinical Support

• Nov 2014 - Jun 2015

Process​ ​ Improvement,​ ​ Systems​ ​ & ​ ​ Business​ ​ Analysis ● Change​ ​ implementation​ ​ & ​ ​ change​ ​ management,​ ​ ensuring​ ​ cGMP-,​ ​ cGLP-compliance ● Cloud​ ​ SaaS​ ​ design;​ ​ user​ ​ & system​ ​ requirements,​ ​ design​ ​ specs,​ ​ IQ,​ ​ OQ,​ ​ PQ​ ​ development ● Develop​, drive​ ​ adoption​ ​ of​ ​ SOPs,​ ​ methods​ & coursework:​ ​ provide train-the-trainer​ training Process​ ​ Improvement,​ ​ Systems​ ​ & ​ ​ Business​ ​ Analysis ● Change​ ​ implementation​ ​ & ​ ​ change​ ​ management,​ ​ ensuring​ ​ cGMP-,​ ​ cGLP-compliance ● Cloud​ ​ SaaS​ ​ design;​ ​ user​ ​ & system​ ​ requirements,​ ​ design​ ​ specs,​ ​ IQ,​ ​ OQ,​ ​ PQ​ ​ development ● Develop​, drive​ ​ adoption​ ​ of​ ​ SOPs,​ ​ methods​ & coursework:​ ​ provide train-the-trainer​ training

Data Support Lead: on assignment to Gilead Sciences

• Feb 2013 - Nov 2014

cGMP Laboratory data​ ​ management​ business & analytics​ ​ for​ ​ Gilead​ ​ Sciences● Supervise access & reporting​ ​ of​ ​ cGMP​ ​ environment,​ ​ FDA​ ​ audits​ & New​ ​ Drug​ ​ Applications● Manage group responsible for controlling and summarizing data for: -- regulatory reports and responses -- resource allocation; quality trending -- senior and executive communications● Lead technology evaluations (validated and business-side), course development and training● Deviation and CAPA reporting

Senior Project Manager

• Sep 2011 - Nov 2014

Project management related to process improvement, data management and business formation● Technology evaluation● cGMP data management● technology briefings, training, coaching● business planning and pro formas

Technical Briefing on assignment to TCCI, Inc

• Sep 2012 - Dec 2013

Support Technical Briefings to Major Accounts on Cloud Technologies, especially as they relate to Software Defined Networking (SDN), Network Functions Virtualization (NFV).

Career Development Volunteer

• 2010 - Jul 2014

Mentor for San Mateo County employment programs ● Create & present multimedia seminars focused on issues related to industry & employment trends ● Generate curricula & teach courses targeting groupware, collaboration (Google Apps for Business) Mentor for San Mateo County employment programs ● Create & present multimedia seminars focused on issues related to industry & employment trends ● Generate curricula & teach courses targeting groupware, collaboration (Google Apps for Business)

Product Marketing Manager

• Oct 2010 - Sep 2011

Data Integrity Solutions, Inc. is an accredited California Public Utility Commission (CPUC) vendor. Data Integrity serves industries and organizations which are focusing on initiatives to improve efficiencies through the reporting, management and reduction of GHG emissions. Carbon process management has complex compliance requirements and issues which demand cost-efficient and proven solutions. To this end, Data Integrity Solutions, Inc., has become FirstCarbon Solutions' preferred implementation partner, and provides software capabilities solution which helps calculate, manage and report GHG emissions.

Associate

• 2008 - 2009

Consultant to inventors and start-ups in the CleanTech industry. "Incubation" services such as business formation, including technology evaluations, business plans, finance sourcing and staffing. Consultant to inventors and start-ups in the CleanTech industry. "Incubation" services such as business formation, including technology evaluations, business plans, finance sourcing and staffing.

Market Development Manager

• 2004 - 2008

Maintenance, Repair and Operations (MRO) supplier. Work with client-base in SE Asia, including telecommunications, broadcast media & manufacturing. Maintenance, Repair and Operations (MRO) supplier. Work with client-base in SE Asia, including telecommunications, broadcast media & manufacturing.

Operations Officer

• 2002 - 2004

Product marketing, marketing collateral, business plans, financial projections, financing Product marketing, marketing collateral, business plans, financial projections, financing

Senior Product Manager

• 2000 - 2002

Solaris open source product & program development management. Press, analyst & major account briefings & presentations. Marketing collateral, white papers, marketing requirement documents, competitive analysis. Solaris open source product & program development management. Press, analyst & major account briefings & presentations. Marketing collateral, white papers, marketing requirement documents, competitive analysis.

Business Development

• 1996 - 1999

Competitive analysis, business plan, market analysis, business development Competitive analysis, business plan, market analysis, business development

Program Manager

• 1990 - 1995

Develop programs based on life-cycle & engineering risk assessment. Phase-development process for pre-release programs. Manage pre-release programs with major, OEM & government accounts. Develop programs based on life-cycle & engineering risk assessment. Phase-development process for pre-release programs. Manage pre-release programs with major, OEM & government accounts.