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Our People

Oriel STAT A MATRIX's consulting and training services stand on a firm foundation of knowledge and real-world experience. Our team includes more than 130 experts in performance excellence, regulatory affairs, product manufacturing and testing, quality management, quality assurance, GMP compliance, and program management.

Their expertise allows them to identify issues, clarify needed decisions, and balance your business needs with compliance requirements.

Oriel STAT A MATRIX team members are based in more than 18 countries, and they speak a wide range of languages.   


Key members of our team:

  • Alan Marash

    Alan Marash - CEO

    Alan focuses on strategic planning and managing Oriel STAT A MATRIX’s key client relationships, partnerships, and global deployments. Alan is committed to maintaining the company’s heritage of driving performance improvement, with the goal of helping customers reach the highest levels of success and profitability.

  • Chad Hedlund

    Chad Hedlund - Sr. VP, Life Sciences Consulting and Education

    Chad provides the overall strategic leadership for Oriel STAT A MATRIX’s Life Sciences Consulting and Education services. His focus is on guiding our customers to a successful market entry of their product (e.g., medical device, IVD, or combination product) while also building and optimizing our customers’ quality and regulatory compliance functions in a manner that balances shareholder, customer, global regulatory, and employee needs. Chad’s experience in life sciences quality management systems and regulatory compliance spans nearly two decades and includes quality, regulatory compliance, technical, and leadership roles at companies such as Medtronic, Boston Scientific, and Guidant.

  • Kate Leith

    Kate Leith - VP, Training and Education

    Kate is responsible for ensuring that Oriel STAT A MATRIX’s Body of Knowledge is up to date with rapidly changing regulatory requirements and includes the tools and topics our customers need in order to stay competitive in a quickly evolving industry landscape.

    Kate brings over 25 years of experience in global quality, compliance, and learning and development in the life sciences sector to Oriel STAT A MATRIX.  Her expertise spans the total product life cycle, including design development, premarket quality, operations and supplier quality, and postmarket surveillance. Strategic accounts value Kate’s keen understanding of competency models and seek her assistance to develop scalable training programs that address their training needs in all facets of quality/regulatory, problem-solving, and technical topics.  Kate’s deep knowledge of regulatory and quality topics – coupled with her keen understanding of developing user-friendly and relevant training content – ensures that Oriel STAT A MATRIX’s training library is the best in the industry.

  • Ed Siurek

    Ed Siurek - VP, Quality Consulting

    Ed has more than 20 years of experience in practical, hands-on application of quality standards, process and continuous improvement, facility and supplier audits, and regulatory compliance in both the pharmaceutical and medical device industries. Ed has supported life sciences organizations on 6 continents and in more than 55 countries, giving him a unique perspective that allows him to easily perform and succeed in diverse environments.

    Ed holds an MS in Information Systems Management from the Keller School of Management in Cleveland, with a concentration in Project Management. He also earned a BS from Purdue University in West Lafayette, IN. He is a certified Six Sigma Green Belt and Black Belt.

  • Richard Vincins

    Richard Vincins - VP, Regulatory Affairs

    Richard brings over 25 years of global medical device, IVD, and pharmaceutical Quality Systems Regulation experience to each customer engagement, employing his extensive expertise in submission content, regulatory classifications, risk management, software-driven products, postmarket surveillance, complaint handling, adverse event reporting, inspection readiness, and auditing.

    Richard is responsible for over 30 FDA 510(k) clearances across 10 different branches. He has been involved in EC certification for 62 technical files covering 30 different project types, varying from Class I through III.   

    Richard holds a BS degree in Biomedical Biology. He is a voting member of ISO US Technical Advisory Groups (TAG) 176 for Quality Management Systems (ISO 9001) and 302 for Auditing Management Systems (ISO 19011).

  • Lori Kahler

    Lori Kahler - VP, Regulatory Affairs

    Lori has 25 years of domestic and international experience in RA/QA, with a broad multifunctional background in regulatory, clinical, and quality assurance. Lori has supported numerous organizations to gain global market entry and advance product performance, and has extensive experience interacting with FDA, the European Medicines Agency and regulatory authorities of individual EU Member States, the Australian TGA, the Japanese Pharmaceuticals and Medical Devices Agency, China’s FDA, Korea’s FDA, Health Canada, ANVISA in Brazil, and other regulatory authorities around the world. 

  • Carolyn Tomlinson

    Carolyn Tomlinson - Director, Quality Systems Training

    Carolyn brings more than 20 years of quality system development and management, quality system auditing, and quality engineering experience to the classroom. Her work experience has been in various industries, including medical device and pharmaceutical products, nonwoven materials, electronics, publishing, and polymer rigid film production. Carolyn leverages her diverse background and real-world experiences to ensure that students obtain a practical understanding of classroom topics. Students consistently comment that Carolyn’s involvement with a broad range of manufacturing technologies helps to personalize and enhance their learning experience.  

    Carolyn holds a BS from Virginia Tech in Chemical Engineering with a minor in Chemistry. She is a certified Six Sigma Black Belt.

  • Ernani Pires

    Ernani Pires - VP, Performance Excellence

    Ernani facilitates quality and productivity improvements using fact-based decision making to achieve key organizational objectives. He draws on more than 40 years of experience in quality management systems and performance improvement methodologies.

    Before joining Oriel STAT A MATRIX, Ernani was the first US President of SGS ICS – one of the largest Certification Bodies in the world.

  • Michele E. Jackson

    Michele E. Jackson - Director, Affiliate Relations

    Michele recruits and maintains relationships with Oriel STAT A MATRIX’s affiliate consultants. He brings 25 years of talent acquisition, staffing augmentation, and business development experience to the team. Most recently, he was a senior talent acquisition consultant for a global pharmaceutical, medical device, and biotechnology firm. 

  • Gina Abudi

    Gina Abudi - Vice President, Program Management

    Gina provides project management guidance and direction for our complex engagements. She has more than 25 years of experience in project management and has served a wide array of industries.

     

Our team is here to help. Call 1.888.532.6360 or contact us online ›