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Martin E. Zuzulo
Managing Director, Americas

Martin 2.jpg
  • LinkedIn

  • Over 30 years in Life Sciences R&D / Mfg

  • 5+ years of industry experience with Biogen (Manufacturing, Technical Transfer, Process Development, and Quality)

  • 25+ years in technical and management consulting (PwC, Deloitte, Accenture, IBM, Parexel)

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Specialties

  • Quality Risk Management 

  • Process Design & Optimization

  • Regulatory Information Management

  • Organizational Development

  • EUMDR / EUIVDR

  • SOP Systems and Process Flow

  • Technical Transfer Operations

Experience

  • Regulatory Information Management Program Lead – Currently leading the Regulatory Affairs Program Planning capability build-out for a leading brain health company’s Regulatory Information Management (RIM) System. The objectives were to develop specific program planning approaches, methods and artifacts to manage the overall RIM program, as well as develop extensible assets for the company’s Transformation Office function. Culminated in successful Go Live.

  • Market Authorization and Change Control Conformance – Led audit and assessment projects for multiple clients in multiple theaters, addressing conformance to change control, registration management, labeling and CAPA and Non-Conformance for both device and specialty pharma. 

  • Regulatory Affairs Organizational Blueprinting – Led the blueprinting design effort for the Regulatory Affairs organization of a leading Specialty provider resulting in increased effectiveness of Regulatory Operations resources and structure. 

  • Clinical Process Transformation – Led a large global team across three theaters in a large multi-million-dollar, multi-year transformational program for a top-tier pharmaceutical company. The complex engagement involved program planning and support for eight workstreams that addressed current and future state process and technology requirements.  

  • Medical Device “Internal” CRO Assessment – Led the process, technology and supplier capability and performance assessment of an internal centralized CRO organization at the largest medical device manufacturer that recently adopted this model.

  • cGMP Risk Assessments – Conducted numerous cGMP risk assessments of retrospective validation data for a variety of pharma and medical device manufacturers. Conducted full facility review and audit programs for inclusion into ELA/PLA submission for companies.  Coordinated on-site SOP and technical transfer operations training programs for multiple companies.

  • Consent Decree Program Management – Coordinated multi-year batch record review for key ethical and consumer products for a large diversified biopharmaceutical company operating under consent decree. Interfaced extensively with production, quality control and human resource groups, and served as the cGMP compliance resource between client and firm. 

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