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Work experience

Aug 2008Present

Founder and Principal


·Developed curriculum for ASQ Quality Certification for Biopharmaceutical and Medical Device   

        Professionals in collaboration with Quality & Productivity Solutions, Inc.

·Delivered a training session on Scope Management at Quality & Productivity Solutions, Inc as a guest


·Current in the Training , Quality, Regulatory and Project Management field with my association with the ASTD National, ASQ, RAPs, ACS, DIA, PMO and PMI in LinkedIn groups.

·Contributed to successful launch of Healthcare Business Women’s Association (HBA) Boston Chapter Mentoring Program in 2009/2010 as a committee member and a connector.

Mar 2011Present


Boston Scientific

Corporate/Global Quality System

Working as part of a Project Transformation Team:

Developing Corporate Quality Procedures for Design Control for multiple sites.

Conducting gap analysis for the current quality practice at multiple sites.

Corporate Audit Support and Training Strategy Development.

Jun 2006Aug 2008

Program/Project Manager (Sr. Quality Engineer)

Boston Scientific

Managed and lead cross-functional teams (18-20 people) from multiple geographical sites including clinical, regulatory, R&D, analytical, and design assurance, in support of regulatory submissions.  Scope included chairing weekly team meetings, monitoring key project milestones, and procedures and investigation progress. Additional responsibility including managing bi-weekly departmental meeting focusing on quality system improvements. Co-managed monthly Review Board meetings consisting of departmental directors and VPs based on expertise in meeting management, facilitation and follow-up.

Key accomplishments included:

  • Initiated a new reporting structure for a Laboratory Information Management System (LIMS), harmonizing regulatory reporting to agencies and freeing up R&D and Quality resources for other projects.
  • Proposed and developed project for quality plan and use of Oracle Clinicalfor extract view of data in SAS for statistical analysis of stability data for regulatory submission in a validated environment in consultation with external consultant, Clinical SQA and Clinical Operations.
  • Planned for submitting wider specification to TUV based on technical justification in collaboration with Principal Regulatory Specialist, Director of EU Regulatory Affairs and Design Assurance.

  • Provided leadership direction and coaching to junior engineers on successful project management and leading investigations, producing more independent employees and freeing up management for more strategic tasks.
  • Successful FDA US Approval of PROMUSTM Everolimus-Eluting Coronary Stent System and second-generation TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System.
Dec 2004Jun 2006

QA Specialist


Scope included quality oversight of contract manufacturers and laboratories. Responsibilities included managing timeline for audit due dates, vendor quality agreement development and renewal. Development and Implementation of Technical Product Complaint Procedures and Process to notify and record complaints including those from the investigator's site.

  • Reviewed and audited CMC regulatory submissions, clinical packaging and labeling design and specification, direction for use (DFU), and clinical expiry documentations leading to approval of HCV protease inhibitor telaprevir (VX-950), Phase III Clinical Trials.
  • Developed and implemented batch record disposition procedures and oversight of development of Corporate Complaint System and validation of OPM. Provided training to Product Development, Supply Chain and Clinical, enabling launch of clinical trials.
  • Developed and Implemented Technical Product Complaint Procedure and Process to notify and record complaint including from the investigators site utilizing ARISg software.
  • Demonstrated knowledge of using ARISg software and trackwise for reporting drug safety and investigation reports.
  • Collaborated with contract laboratories and manufacturers in EU and US to conduct monitoring and requalifying audits.
Nov 1997Jun 2004

Associate Scientist II

Biogen Idec

Biogen Idec, Cambridge, MA  Initially recruited as a Development Chemist to do Analytical Method Development and rapidly promoted to Associate Scientist II. Scope included supplier and laboratory management. 

Oversight of corporate clinical and commercial stability program.                                                                                                                                   

Associate Scientist II/ Stability Project Manager (2001- 2004)Associate Scientist II (1999-2001)                                                                                                        Development Chemist (1997-1999)

  • Provided leadership direction and training to Formulation Development scientists and associates on new analytical methods, instrumentations and software applications, producing more competent users.
  • Contributed to successful FDA US Approval of AMEVIVE® (alefacept) and Avonex® Liquid.
  • Collaborated with clinical operation, QA and product development in managing  timeline of clinical expiry dating and batch disposition for clinical use.
  • Presented new protein characterization methods and initiated a literature review committee for Pharmaceutical Sciences and Technology Department, encouraging open dialogue and effective experiment design.
  • Collaborated with external suppliers for maintenance of laboratory instruments and data analysis and reporting.


Higher National Diploma

Halton College

Halton College/ICI Chemicals & Polymers Limited, Cheshire, UK

Higher National Diploma, in Chemistry (First Year).

May 1993Jul 1997

Masters of Science

University of New Mexico/Sandia National Laboratories, Albuquerque, NMMasters of Science in Physical and Biochemistry.  Course work included two semesters of graduate level Frontiers of Medical Biology and a semester of Bioinorganic chemistry.

Sep 1989May 1993

Bachelor of Arts

Middlebury College

Middlebury College,  Middlebury, VT

Bachelor of Arts in Inorganic Chemistry, cum laude


Computer and Quality Applications
  Visio, Microsoft Project, Minitab, SPC, Six Sigma, PDM, SDMS, LIMS, LMS (Learning Management System) and Track Wise.    
Project Management
  Quality Management Systems Chemistry Manufacturing and Controls Global Drug Stability Program Training and  Development  Corporate Audit    


Karen Malik

Audrey Louie

Kathleen Francis



Quality and Regulatory Strategy 

Quality Management Systems

Project and Program Management

Design and Development

Chemistry Manufacturing and Control

Internal and External Audit



Personal Development

Leadership Development

Organizational Development



Find Your Solution


Seeking a Quality/Regulatory program lead position utilizing my expertise in developing Regulatory and Quality compliance related programs for Medical Device and Pharmaceutical companies. Strategic skills include problem solving, quality decision, business acumen, strategic agility and having perspective. Excellent communication, client relationship management and leadership development skills. US Citizen. Core competencies include: • Quality and Regulatory Strategy Quality Policy/Procedure Development and Training• Program & Project Management

• Risk Management

• Quality and Laboratory System

• Drug, Device and Software Development Process

Recognized for successful FDA Audit Preparedness and Support at Boston Scientific. Biogen Award for outstanding improvement of Corporate Drug Stability Program.


Project Management Seminar

Cadence Management Corporation

Master Certified Coach of NLP

American Board of Neuro Linguistic Programming, NLP