Kelly Hnat's Location
Pottstown, Pennsylvania, United States, United States
Kelly Hnat's Contact Details
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About Kelly Hnat
Recognized industry leader in Regulatory Information Management and IDMP, including active participation on the EMA SPOR Task Force. Accomplished business process, organizational strategy, and technology leader with a reputation for building strategic business partnerships and leading top performing teams in execution of global programs.
Kelly Hnat Work Experience Details
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RetiredNoneUnited States
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PrincipalK2 Consulting | K2Rim.Com Apr 2018 - PresentHead small specialty consultancy providing expertise in business processes and systems for Regulatory Affairs and its partner functions. Services include systems strategy & vendor selection, project & program management, expert facilitation, and expert advisory on topics such as regulatory CMC conformance, IDMP, SPOR, electronic submissions, and other critical and emerging topics and standards. www.k2rim.com -
Board MemberIriss Forum (Iriss-Forum.Org) Feb 2023 - Present -
President & CeoIriss Forum (Iriss-Forum.Org) Dec 2020 - Feb 2023
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Vice PresidentIriss Forum (Iriss-Forum.Org) Apr 2018 - Dec 2020
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Senior Director, Regulatory Information ManagementTeva Pharmaceuticals Sep 2014 - Mar 2018Global head responsible for all aspects of implementation, improvement, and support of systems and processes related to the work of Global Regulatory Affairs and its partner functions. Oversaw implementation of new capabilities across Regulatory Operations, Labeling, Regulatory Strategy, Publishing and global document management. Actively represented Teva and Medicines for Europe in industry-wide initiatives including EMA SPOR Task Force and EU Falsified Medicines Directive (FMD), providing leadership on behalf of industry in these activities. Co-chair of Medicines for Europe Telematics Working group. -
Interim Head, Specialty Pharma Global Regulatory OperationsShire Pharmaceuticals Apr 2013 - May 2014Interim head overseeing all aspects of Global Regulatory Operations for Shire’s Specialty Pharma division, including Submissions Management, GRA Information Technology, and Quality, Standards and Training. -
Director, Global Regulatory Quality Standards & TrainingShire Pharmaceuticals Sep 2011 - May 2014Chesterbrook, PaLead business process development/continual improvement, organizational strategy, compliance and training for the Global Regulatory Affairs organization. Partner closely with Regulatory Affairs leadership and R&D/Commercial business functions to identify and execute initiatives to establish new and improve existing capabilities across the drug development and commercial lifecycle. Provide leadership in business aspects of GRA and R&D-wide system management including enterprise document management.
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Director, Regional Cmc Conformance HubsPfizer Pharmaceuticals Jul 2010 - Sep 2011As a member of the leadership team, spearheaded operational implementation of a new global regulatory CMC organization. Partnered closely with senior leaders of regulatory and commercial stakeholder organizations to ensure the scope and remit would meet the complex business requirements of a global supply chain and market. Ensured successful integration of the new organization into the global business model for managing conformance of CMC regulatory filings in all markets. Led a multifunctional team of consultants and colleagues to establish all business process interfaces with stakeholder organizations across the globe and through all of Pfizer’s human health business units (Pharma, Biopharma, Consumer Health and Nutritionals) and ensure the necessary systems were in place to support these. -
Pfizer Medical Integration Leadership TeamPfizer Pharmaceuticals Mar 2010 - Jul 2010
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Director, Global Product Conformance Systems & DeploymentWyeth Pharmaceuticals Apr 2008 - Mar 2010As a member of the leadership team for Wyeth’s Global Product Conformance (GPC) program, led technology development, system and process deployment, and change management components of this $100MM global regulatory compliance initiative. Directed local and global sub-teams of internal and contracted resources to successfully develop and globally deploy an integrated suite of systems spanning manufacturing, quality, regulatory and local commercial processes to all of Wyeth’s 65 country affiliate offices and 31 plants worldwide. Accountable for development and integration of multiple systems, GMP validation, global classroom training, communication, change management, country office and manufacturing site deployment. Established the organization necessary to support the system suite and processes post-deployment. Responsible for $25MM of the total $100MM program budget and 40+ resources. Delivered on budget within short timelines. Achieved full global deployment in an unprecedented six-month period.Following acquisition of Wyeth by Pfizer was a member of the integration leadership team that planned the incorporation of key achievements of this program into the integrated company’s future business processes.
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Business Systems & Processes (Bsp) Business PartnerWyeth Pharmaceuticals Aug 2003 - Jul 2008As internal consultant, owned the IS relationship with Wyeth business units. Led teams responsible for delivering solutions to establish new capabilities and support established production systems. Established and developed strong relationships with business unit executives and functional leaders, working in close partnership to understand the short- and long-term business goals and objectives of each organization and develop technology strategies to support their realization. Accountable for all aspects of defining and managing technology budgets for client organizations. Directed teams in all aspects of technology planning, software selection/development, project execution, and production support. Established a change management framework to support successful adoption to ensure business success of all initiatives and led expansion of this model across the full R&D Business Systems and Processes organization.
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Director, Global Regulatory Affairs Business Systems & ProcessesWyeth Pharmaceuticals Jan 2007 - Jun 2008Areas of responsibility included Global Regulatory Strategy, Global Regulatory Operations, CMC, Global Internal Audit, and Policy & Intelligence
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Associate Director, Global Safety Surveillance & Epidemiology Information SystemsWyeth Pharmaceuticals Jul 2005 - Dec 2006Areas of responsibility included Global Safety Operations, Medical Pharmacovigilance, GSSE Project Management
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Manager, Global Medical Affairs Information SystemsWyeth Pharmaceuticals Aug 2003 - Jul 2005
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Consultant, Research ApplicationsWyeth Pharmaceuticals Sep 2001 - Jul 2003
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Manager, Corporate Is ApplicationsWyeth Pharmaceuticals Feb 1999 - Sep 2001
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Information Systems ConsultantIndependent Consultant 1997 - 1998
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Project ManagerMediphacs 1995 - 1996
Kelly Hnat Skills
Pharmaceutical Industry
Strategy
Regulatory Affairs
Cross Functional Team Leadership
Business Process
Validation
It Strategy
Gmp
Program Management
Regulatory Requirements
Fda
Change Management
Business Analysis
Project Management
21 Cfr Part 11
Management
Leadership
Process Improvement
Change Control
Integration
Organizational Design
Software Documentation
Training
Process Simulation
Documentum
Business Process Improvement
Kelly Hnat Education Details
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Summa Cum Laude
Frequently Asked Questions about Kelly Hnat
What company does Kelly Hnat work for?
Kelly Hnat works for None
What is Kelly Hnat's role at the current company?
Kelly Hnat's current role is Retired.
What is Kelly Hnat's email address?
Kelly Hnat's email address is ke****@****ast.net
What is Kelly Hnat's direct phone number?
Kelly Hnat's direct phone number is +161042*****
What schools did Kelly Hnat attend?
Kelly Hnat attended Temple University.
What skills is Kelly Hnat known for?
Kelly Hnat has skills like Pharmaceutical Industry, Strategy, Regulatory Affairs, Cross Functional Team Leadership, Business Process, Validation, It Strategy, Gmp, Program Management, Regulatory Requirements, Fda, Change Management.
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