Experience

IDEAYA Biosciences

• United States
• Biotechnology Research
• 1 - 100 Employee

• Vice President of Quality

  • Oct 2023 - Present

  Head of the Quality organization responsible for all aspects of GxP Compliance including GCP, GMP, and GLP. Provide leadership to quality staff and provide strategic direction for the Quality function. Collaborate with senior leaders across the organization to ensure business objectives are met while building an appropriate Quality approach to ensure alignment with regulations and industry best practices across IDEAYA’s clinical programs.



Pinnacle Consulting Group

• United States
• Government Administration
• 1 - 100 Employee

• Principal Owner

  • Jul 2023 - Present

  Helping client companies with full spectrum GxP services including Quality Systems implementation, issue management and resolution, auditing and vendor management, training, batch release, regulatory inspection readiness, and general consultancy. Broad experience working with companies across all phases of the development lifecycle from early Clinical through Commercialization.



Sierra Oncology

• United States
• Biotechnology Research
• 1 - 100 Employee

• Vice President Of Quality (acquired by GSK)

  • Nov 2020 - Jun 2023

  Lead the Quality Organization through Sierra acquisition by GSK in June 2023. Provided strategic and operational leadership for all GXP activities with a focus on developing a sustainable Culture of Quality. Positioned the organization to support Development activities while building for Commercial readiness and launch. Developed and implemented a Quality Management System to support Commercialization.

• Senior Director Quality

  • Nov 2019 - Nov 2020

• Contractor/Consultant

  • Mar 2019 - Nov 2019

  - Assisting with risk mitigation activities in preparation for NDA filing and subsequent PAI, including strategic planning, coaching of staff, source document review and mock inspections. - Strategic PM for commercial manufacturing expansion facility including regulatory strategy for integration into existing aseptic facility.



Gilead Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Director, Quality

  • Nov 2018 - Mar 2019

  Foster City

• Director, Quality

  • Mar 2015 - Nov 2018

  Foster City



Nektar Therapeutics

• Biotechnology
• 300 - 400 Employee

• Director of Quality Assurance

  • Jul 2014 - Mar 2015

• Associate Director of Quality

  • Dec 2010 - Jun 2014

• Consultant

  • 2004 - Dec 2010


Novartis
• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Consultant

  • Jan 2009 - Dec 2010
• Owner

  • Jan 1997 - 2010

  SF Bay Area


The Macroflux Corporation
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Consultant

  • 2007 - 2008

Alza Corporation
• United States
• Validation Consultant

  • 1997 - 2005

Johnson and Johnson / Alza corp.
• Validation Consultant

  • 1997 - 2005


Validation Contracting Company

• Validation Engineer

  • Mar 1996 - Jan 1997

  SF Bay Area



McGhan Medical

• Process Validation Specialist

  • Jan 1995 - Mar 1996

  Santa Barbara, CA Process Validation for Class III Medical Devices.