Executive Leadership Team

Executive Leadership Team

Michael Khavinson
Michael Khavinson
CEO
Michael has more than 29 years of experience working in the pharmaceutical, biotechnology, and consulting service industries. His primary role is to facilitate new business partnerships and investments for Azzur and its subsidiaries. He oversees the complete management process and delivers executive decisions supporting Azzur’s success.

Prior to Azzur, he held high-level management positions in several companies including CQV, and Stelex Inc. Michael uses his expertise in business strategy and quality assurance to ensure proper management and to advance the growth of Azzur.

Michael’s favorite color is orange. He is married with two children. His hobbies include setting up an annual model train display at Reading Terminal Market ACME Railroad, and sailing on his boat Com Pari Brieze. Michael received his Bachelor’s degree in Computer Science from Temple University.

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Michael Khavinson
Michael Khavinson
CEO
Dave Manku
Dave Manku
General Manager
Dave has more than 20 years experience in consulting in the FDA regulated and water treatment industries. He is a co-founder of BioSPEQ, Inc., a full-service consulting firm to the biotech/pharmaceutical, medical device, and food/cosmetics industries that merged with Azzur in 2014.

Dave has undergraduate degrees in Biochemistry and Chemical Engineering and a Master of Engineering degree in Chemical Engineering, all from the University of Ottawa. Dave is a registered professional engineer in Ontario, Canada.

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Dave Manku
Dave Manku
General Manager
Kevin Martin
General Manager


Kevin has over 40 years of FDA regulated industry experience that includes management positions at Wyeth and McNeil Pharmaceutical. He is considered a subject matter expert on risk-based systems validation conducted within QA, IT, Manufacturing, Operations, Clinical and R&D in FDA regulated environments.

He was a member of the PhRMA Computer Systems Validation Sub-Committee, was the Core Team Secretary for the PDA Part 11 Task Group, former co-chair of GAMP Global, and was previously a chair on the GAMP Americas Steering Committee.

He received his Bachelor's degree in Chemistry from Delaware Valley College of Science and Agriculture, and his Master's of Engineering from Penn State University.

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Kevin Martin
Kevin Martin
General Manager
Michael Kazakevich
Michael Kazakevich
General Manager
Michael serves as the General Manager of Azzur Solutions. Michael brings to Azzur more than 30 years of experience in technology recruiting, bringing together trusted expert teams to meet the needs of fast-growing companies. Throughout his time in the industry, Michael’s also developed a keen understanding of the cybersecurity technology, enterprise and network infrastructure, and data center services required to meet the needs of today’s IT.

Prior to building Azzur Solutions, Michael co-founded Quatro Systems, Inc., providing technical expertise to Fortune 500 and government organizations; Quatro was acquired in 2017.

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Michael Kazakevich
Michael Kazakevich
General Manager
Ryan Ott
General Manager


Ryan Ott is Managing Partner and Member of the Board of Directors for Azzur Group, LLC. He is also the co-founder of Azzur IT. Ryan is directly responsible for growing the depth and breadth of Azzur service offerings to the global Healthcare and Life Sciences industry. Ryan’s responsibilities include general management of Azzur IT, maximizing customer-partnerships and service delivery opportunities, identifying and developing new talent, and overseeing service delivery for Azzur customers.

Ryan has over 20 years experience working in a variety of FDA-regulated environments. His past experience reflects a broad understanding of IT quality & compliance, with consulting projects ranging from bespoke system implementation, integration and validation to enterprise-wide IT quality remediation. Ryan has an in-depth understanding of current GxP regulations and industry best practices, including GAMP 5.

Ryan is an active member of several professional organizations including ISPE, PDA, and ASQ, and has been involved with GAMP Americas as a Steering Committee member since 2015. He holds a Bachelor of Science from Allegheny College and has also completed post-graduate work in Regulatory Affairs & Quality Assurance at Temple University.

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Ryan Ott
Ryan Ott
General Manager
Shaleen Parekh
Shaleen Parekh
General Manager
Shaleen is a co-founder of BioSPEQ, Inc., a full-service consulting firm to the biotech/pharmaceutical, medical device, and food/cosmetics industries that merged with Azzur in 2014.

He continues to use his extensive cGMP experience in project management, quality system development, validation and process engineering to facilitate growth for Azzur. He is also focused on continuous improvement and operational excellence, driving key strategic projects to meet customer requirements in a timely manner.

Shaleen is an avid fan of the NBA (Los Angeles Lakers) and NFL (Indianapolis Colts). He received his B.S. in Biological Sciences from the University of California, Irvine and M.S. in Physiological Sciences from the University of California, Los Angeles.

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Shaleen Parekh
Shaleen Parekh
General Manager
Chris Mansur
General Manager


Chris Mansur is a general manager of Azzur New England who has been with Azzur since March of 2013. Chris specializes in mechanical C&Q, process and cleaning validation, computer system validation, and quality systems implementation. Chris loves working with Azzur because he likes helping companies solve problems that accelerate their product's lifecycle or project timeline while also helping employees take their career to the next level. He believes that Azzur's experienced team of experts understand the first-hand pains associated with pre-GMP startup, scale-up, and capital expansion and commercial operations. In addition to working with Azzur, Chris is a member of ISPE and PDA.

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Chris Mansur
Chris Mansur
General Manager
Kym Faylor
Kym Faylor
General Manager
Kym has over 20 years of experience in managing a microbiology laboratory and assuring compliance with governing agencies, client specifications, and developing the quality assurance aspect to conform to current advances in pharmaceutical, medical device, biotechnology and cosmetic industries. She has an extensive background in microbiology, specializing in validation of microbiological methods and compendia testing. Her experience includes compliance with USP, FDA, ISO, EU, AAMI & AOAC requirements, general microbiology testing, Environmental Monitoring data analysis and trending, and microbiology quality assurance programs. Recent certifications include: Certificate from UCSD in Regulatory Affairs, certified manager of quality/organizational excellence, and certified quality auditor from ASQ. Kym also serves on the Controlled Environments Testing Association as a board member, American Society for Microbiology as a Science Educators Network Mentor & Reviewer, and Society for General Microbiology as a reviewer.

Kym is a member of Regulatory Affairs Professional Society (RAPS), American Society for Quality (ASQ) -Senior Member, Parenteral Drug Association (PDA), Institute for Validation Technology (IVT) and Bio-pharmaceutical Education and Training Association (BETA). She has several publications and has served as a lecturer & trainer for USP <797> compliance.

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Kym Faylor
Kym Faylor
General Manager
Ravi Samavedam
General Manager


Ravi is a general manager for Azzur Group who has been with the company since 2012. His area of expertise lies in phase appropriate GMP implementation, validation, and supplier management. Ravi loves working with Azzur because together they can help bring critical therapies to market. He believes clients benefit from their risk-based approaches and speed and technical depth.

In addition to working for Azzur, Ravi is an active member of PDA and ISPE.  He has given several presentations at industry events over the last 12 years, and has been invited to speak at the FDA Well Characterized Biologics event in 2007.

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Ravi Samavedam
Ravi Samavedam
General Manager
Shelley Preslar
General Manager


Shelley is a general manager for Azzur Group and managing partner of Azzur Group, North Carolina. She's been with the company for over ​three and a half years. Shelley's service area of expertise is solving unique challenges related to delivering project results in all types of environments, including, compliance, quality​,​ validation, project management, and training. Her passion lies in helping other people succeed, whether with her family, team, or clients. 

Shelley works with Azzur to help make clients successful. Her driving motivator alongside of Azzur Group is to help clients ​achieve the most desirable project outcome by adding value to the process. In addition to working with Azzur, Shelley serves as the current Chair of the International Facilities and Engineering Interest Group of PDA​, and supports multiple technical and program committees.​

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Shelley Preslar
Shelley Preslar
General Manager