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75 Phillips Road, Sudbury, MA 01776 Mobile (206) 229-6002


Pharmaceutical ~ Biotech ~ Medical Device

Accountable and accomplished Director of Quality with over 20+ years experience in Quality Management in various
companies ranging from clinical to commercial. Expertise in the areas of validation technology and evaluating trends in FDA
regulated industries. Spectrum of professional knowledge includes: Aseptic Filling, Solid Dosage, Medical Devices, Cell Culture,
Tissue Engineering and Immunotherapy. Ability to balance regulatory, science and business needs as well as coach and develop
quality professionals to meet and exceed the challenges of their daily work.

Extensive expertise in the development, testing, implementing and leading of various Quality functions as well as
streamlining the Quality process while complying with government regulations. Adept at interfacing with regulatory bodies such
as the FDA, ISO, TGA (Australian) and EMA (EU). Partner with contract manufacturing organizations, engineering department,
operations, QC, IT and executive leadership. Dedicated to apply sound engineering principles to provide solutions and options
that meet the business and regulatory requirements.


Corporate Validation Program

Document Control Management



QA Compliance
Change Control Management
GMP Best Practices

Project Management
Calibration & Maintenance
Compliance Remediation

Gilead Sciences, Foster City, CA
Principal Quality Consultant, 2014-Present
Challenged to manage equipment validation of a new solid dosage pilot plant used for clinical manufacturing.
Provide management support.
Resolved various deviations by working closely with Quality Assurance.
Genzyme (a Sanofi Company), Boston, MA
Director of QA, Global QA Consent Decree Management Office, 2012-2014
Led teams through work plan deadlines for the consent decree.
Successfully delivered against penalty related milestones agreed with FDA.
Strategically collaborated with third party verifiers to complete in-place and in-use validation programs.
Executed gap assessments against new corporate standards in order to achieve verification.
Successfully accomplished the remediation steps for in-use verification for the Validation Life Cycle, the Lab Equipment
Qualification, Storage and Distribution, and the Requalification programs numbered steps.
Dendreon Corporation, Seattle, WA
Senior Director, Corporate Validation, Quality Department, 2004-2011
Leveraged extensive knowledge of Quality and Validation Management to organize and establish a Corporate Validation
program consisting of Validation Engineering at all facilities, a corporate Computer Systems Validation group and a
corporate Process/CMO Validation group.
Successfully passed the PAI inspection of the first US commercial Immunotherapy Manufacturing Facility in 2010 located in
Managed the Validation process for two additional sites in the US (CA & GA) as well as a CMO site in Europe.
Implemented Corporate Policies for all commercial sites in the US and clinical site in the EU.

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Senior Director, QA Compliance & Validation, Quality Department
Promoted from Director to Sr. Director
QA Compliance
Directed and implemented the corporate compliance program between headquarters in Seattle and the manufacturing facility
in New Jersey.
Led all aspects of Change Control from document to engineering and process change controls.
Oversaw and managed the Document Control department and implemented an Electronic Documentation System.
Administered Compliance and Validation support to a BLA filing and a new facility Pre Approval Inspection.
Successfully interacted with FDA during PAI to defend our Risk Assessment approach, various validations and change
Validation Engineering
Successfully established the corporate Validation Department to support both internal and external validation systems and
brought the facility up to the required compliance standards.
Led the validation efforts of various electronic systems such as ERP (Oracle), LIMS (LabWare), Calibration and
Maintenance database (Maximo then transferred to Blue Mountain Regulatory Asset Management) and a Document
Management System (Qumas Edocs then transferred to Documentum).
Created a Validation Master Plan using ISPE guideline for a commercial facility in New Jersey.
Successfully led the validation efforts of three First in Class immunotherapy facilities (approx 120,000 sq ft each).
Validated a new clean room and QC lab at the American Red Cross for our clinical Cell Processing Center.
Developed a departmental budget and hired additional resources.
Oversaw and managed the Calibration program and Facilities after a major workforce reduction in 2007 for a year.
Amylin Pharmaceuticals Inc., San Diego, CA
Director, Validation & Metrology, Operations Department, 2002-2004
Promoted from Associate Director to Director
Established and staffed a fully operational Validation department.
Created a Computer Validation Master Plan as well as a road map for 21 CFR Part 11 compliance.
Successfully validated 10 of the highest risk software programs within first 6 months to prepare for an FDA pre-approval
Established a software and equipment change control system. Work closely with IT on software life cycle to transition from
development to validation to production environment.
Initiated qualification program for GLP labs.
Organized, created and staffed a fully operational calibration system.
Validated and employed the use of Blue Mountain CalManager 4.0 (Part 11 compliant database and calibration recall
Implemented an Out Of Specification program for GXP equipment as well as deviation reports for R&D.
Advanced Tissue Sciences, Manufacturing Operations, La Jolla, CA
Director, QA Technical Services, Quality Systems Department, 1997-2002
Promoted from Validation Manager to Director of QA Technical Services
Spearheaded efforts to keep company compliant to all validation requirements including, equipment, process, cleaning and
computer validation.
Quality Engineering
Significantly reduced errors and implemented cost saving initiations.
Test Methods Development
Developed and validated various assays working closely with R&D, PD and QC.

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Quality Systems Department
Achieved great success by creating a centralized validation department responsible for all validation activities and technical
support to QA, Regulatory Affairs, Manufacturing, Facilities and Engineering.
Managed companys validation department and budget, and reports directly to the VP of Quality Systems.
Successfully recruited and trained five validation professionals from technician to senior engineer levels.
Reduced over 80% of outside consultant spending by implementing in house training and validation expertise.
Authored and implemented various Quality Systems policies to increase compliance with FDA regulations as well as
international regulatory bodies.
Engineering Department
Implemented and managed companys validation program for all equipment and utilities.
Led and mentored various consultants and project engineers in order to validate the new facility on time and within budget.
Implemented and chaired companys Change Control System.
Purchased, designed and installed various process equipment including large-scale incubators and cryogenic equipment.
Collagen Corporation, Manufacturing Operations, Fremont, CA
Validation Assurance Supervisor, Quality Assurance Department, 1995-1997
Promoted from Validation Engineer to Validation Supervisor
Managed validation staff as well as outside contractors on various projects in manufacturing and QC.
Served as member of the company's Change Control and Operations Communication committees.
Wrote and performed IQ/OQ's on production parts washer, depyrogenation oven and various manufacturing process changes.
Wrote various validation SOPs on IQ/OQ's and computer validation.
Completed autoclave, SIP systems and media fills revalidation studies.
Hoffmann-La Roche Inc., Pharmaceutical Operations, Nutley, NJ
Validation Engineer, Pharmaceutical Validation Development and Services, 1993-1998
Executed IQ/OQ and validation on mixing vessels and HVAC system for a new liquid production facility.
Wrote and executed the computer validation of clinical packaging software, capsule checkweighers and a facility
environment monitoring system.
Created and established protocols pertaining to process and computer validation.
Organon Inc., Akzo Pharma Division, West Orange, NJ
Process Validation Engineer II, Technical Services, 1991-1993
Formulated and composed clear, defined IQ/OQ and validation documents in accordance with cGMP's and FDA guidelines.
Generated trend analyses and trained entry level Validation Specialists.
Conducted validation studies on autoclaves, lyophilizers, depyrogenation ovens, deionized water system, and HVAC system
for clean rooms and controlled areas.
Completed scale up of terminal sterilization of a new product: this project included intensive terminal sterilization studies as
well as software validation on a new production autoclave.


New Jersey Institute of Technology, Newark, NJ
Master of Science in Engineering Management, 1997
Bachelor of Science in Electrical Engineering, 1991
Fluent in English and French.
Internships at: Panasonic, Becton Dickinson & Company and DuPont de Nemoure & Company

Member of the Institute of Validation Technology (IVT)
Member of The International Society for Pharmaceutical Engineering (ISPE)
Member of the Parenteral Drug Association (PDA)

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