Quality Control Director Biotech/Pharma

 

PROFILE

 

Leader with over 20 years in the Pharmaceutical industry with experience in Research Discovery and within Quality Operations. Career emphasis has been on leading multi-  site and multi-country teams delivering to global customers while maintaining GMP operations that follow lean concepts to facilitate continual improvement. Most recent leadership experience has been with Quality including Quality Control and Quality Assurance activities, implementing product Quality system documents and business processes to sustain compliance, data integrity of paper & electronic systems, leading contamination investigations, compliance auditing of outside services, CAPA and discrepancy management, training, technology/business functional transfers and strategic business design. Genentech/Roche Quality Certification program graduate and trained on data integrity assurance, investigations and governance. Strong belief and passion in the leadership role of selecting and hiring best fit candidates which then deserve consistent follow-up for career development and coaching for their success.

 

Areas of personal leadership experience

 

  • Accountable person for the Quality and Compliance of the manufacturing cell bank testing program, both internal and contract testing

 

  • Strengthened the long-term alignment and compliance to Quality systems and to lean operational principles by integrating the cell bank testing program into Commercial Quality operations from
  • Increased efficiency of the contract lab testing management and data intake review by defining standard work business processes with a result of reducing FTE work effort while increasing compliance to internal quality

 

  • Accountable person for the long-term business strategy and operational Quality and Compliance of network adventitious agent testing labs in the US and Asia for both clinical and commercial

 

  • Designed and implemented a global network Quality Control adventitious agent testing function purposed for routine sample screening & validation Laboratories in the US and Asia operate as a single functional unit sharing workload with the same methods, training, critical reagents, equipment, and business process to deliver methods suitable for purpose, regulatory filing chapters and final reportable results for release of products manufactured worldwide. Integrated new nucleic based methods into the business structure to facilitate shorter product release times.1

 

  • Accountable person for QC regulated materials, reference standards & critical reagent replenishment, warehousing and distribution for biologics manufacturing sites

 

  • Reduced FTE workload and increased inventory and distribution capability by combining existing QC functions with similar business deliverables to insure cost effective world-wide and sustainable delivery of qualified reagent

 

  • Accountable person for Quality control cell culture operations purposed with the generation, maintenance, banking and distribution of cell lines used in QC methods

 

  • Increased capability of the now largest cell culture facility, generating 45,000 culture vessels of cells per year while maintaining over 20 continuous cell Functional design increased cell line capacity over the years without increase in FTE spend.

 

  • Accountable person for Quality Assurance oversight within a Global QC function; Oversight of CAPA & discrepancy management, compliance assessments, implementation of product quality system documents and E2E business process design for maintaining Quality system

 

  • Turned around less than favorable discrepancy and CAPA closure performances to a sustained 98 – 100% on-time closure through developing planned execution to closure ‘standard-work’ following lean principles.

 

  • Managing QC potency testing for product release at the site

 

  • To reduce operational cost and waste, removed unnecessary functional testing activities and FYO testing thus reducing FTE workload to be redistributed for other functional

 

  • Head of laboratory leading multisite research efforts for discovery of new therapeutic molecules for therapeutic vision related

 

  • Led dedicated experienced and cross functional and multi-laboratory teams to develop and then implement large scale research screening efforts for novel peptides using cell culture and molecular

 

 

EDUCATION

Doctor of Philosophy, Neuroscience

Master of Science, Biology

Bachelor of Science, Biology

Associate of Science, Biology

 

 

CERTIFICATION

Quality Certification

 

PRESENT POSITION

QC Director, Global Biologics QC, 2012 – present

  • Accountable person for operational Quality and Compliance of global adventitious agents testing labs in California and
  • Accountable person for global QC Critical Reagent
  • Accountable person for QC Cell Culture
  • Accountable for manufacturing cell bank testing and contract lab

 

PREVIOUS POSITIONS

QC Associate Director, QC Network/Global Biologics QC, 2008 – 2012 Sr. Manager, QC, 2002 – 2008

Manager, QC, 2000 – 2002

 

Research Associate Scientist, , Research Discovery, 1994- 2000

 

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