About MWA

Our History

 

Since 1995, MWA Consulting (formerly known as Marion Weinreb & Associates, Inc.) has successfully partnered with clients worldwide to meet and exceed their regulatory compliance requirements and guidelines.

MWA provides exceptional compliance consulting expertise from development through commercialization for the pharmaceutical, biotechnology, cosmetics, dietary supplements and medical device industries. We are a trusted and reliable choice for your GCP, GLP, and GMP compliance consulting projects and audits.

With over 300 experienced associates in the US, Canada, India, Europe, and South America, we are geographically positioned to provide expert resources in the most cost-effective and timely manner.

MWA specializes in working with virtual start-ups, midsize and large established companies. Our associates have guided companies in implementing phase- appropriate Quality Management Systems with a hands-on approach. Our experienced associates work closely with clients to develop procedures that are compliant with current regulations, standards and guidelines, yet avoid the pitfalls of implementing too much, too soon.

Mission and Values

 

We offer quality and operational expertise to the life sciences industry, delivered from a strategic perspective with agility and efficiency.

Our mission is to:

  • Be the premier provider in GXP compliance consulting to the pharmaceutical, medical device, and biotechnology industries
  • Deliver innovative and holistic solutions to our clients
  • Uphold the highest standards of excellence in all aspects of the business
  • Establish and maintain strong partnerships to produce exceptional results

Meet Our Team

Ruben Taborda, CEO
Ruben is the CEO for Automation & Validation Solutions, LLC, which acquired MWA in January 2024. Ruben worked for 35 years as a Johnson & Johnson executive spanning a broad range in the healthcare sector. Most recently, he was VP, customer success (Supply Chain) where he was responsible for development and deployment of solutions that improve medical device delivery across a $1OB business. His team achieved best in class Net Promoter scores by customers. He also served as Senior VP in Sales, Account Management, Procurement, Finance, Logistics and Manufacturing in the Pharmaceutical and Medical Device sectors.

Lisa Helmonds, Vice President of Quality and Operations
Lisa’s focus is on developing and maintaining relationships with MWA’s consulting clients, implementing training programs, and ensuring that MWA’s consulting team continues to offer the highest quality services in the industry. Lisa has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry. She holds a BS in Zoology from the University of Rhode Island and an MBA from Santa Clara University.

Sumaiya Reza, Vice President of Client Services
Sumaiya oversees MWA’s client relations and business development strategies built on the successful match between client needs and our qualified consultants. Her tenure in the biopharmaceutical industry spans across Research and Development, Supply Chain Management, and Quality Operations. She has led many Quality and Project Management efforts within Global 500 Biotechnology companies and believes that great connections, in personnel and knowledge, are foundational toward achieving improved systems and services in health care. Sumaiya holds a BA from UC Berkeley in Molecular and Cell Biology, as well as MS degrees in Business and Biological Science.

Paula Pilecki, Senior Director, Project and Audit Management
Paula is the primary contact for clients and associates to schedule and oversee auditing projects and ensure compliance with scheduled timelines and deliverables for MWA audits. Additionally, Paula is responsible for screening and qualifying new associates, and providing communication updates on relevant GXP issues to both clients and associates. Prior to joining the MWA team, Paula was an executive in the non-profit sector, concentrating on the intersection between human resources and organizational management.

Michelle Hoover, Senior Manager, Account Management
Michelle is an experienced client services leader in the pharmaceutical industry in areas of Contract Manufacturing, Supply Chain, and Development. She has over ten years of experience with customer account management and is skilled in project management principles. Michelle holds a Project Management Professional (PMP) certification from the Project Management Institute (PMI) and a BS in Public Affairs from Indiana University.

Will Daniels, Finance Director
Will specializes in business leadership, financial management, and optimizing client relations. He has led finance, sales, and marketing teams for both small businesses and Fortune 500 companies. This includes developing and maintaining successful partnerships with clients such as Charles Schwab, Oracle, and Netflix. Knowledgeable on all things numbers-related, Will provides financial clarity and support for both clients and associates. A graduate of University of California, Santa Barbara, he is also a dedicated fitness enthusiast and world traveler.

Marion Weinreb, Founder and Advisor
With over 40 years of quality systems experience in the medical device and pharmaceutical industries, Marion has worked at major companies like Altana, Inc., Forest Laboratories, Johnson & Johnson, Syntex and Roche Bioscience. She focuses on GMP and/or QSR auditing in both non-sterile and sterile drug and device systems, Pre-Approval Inspection preparation, mock audits, quality systems development and continuous improvement, cGMP training, GMP document development, and problem resolution for compliance issues. She has worked for small and large companies and has a successful track record for dealing with complex compliance issues in Development and Commercial settings. Marion holds a BA in Biology and an MS in Pharmaceutical Marketing.

Giving Back

 

Each year MWA partners with a charity to contribute to & strengthen our community. We believe it is a duty and hold it as a privilege to be a part of such endeavors. Previously we have worked with: