Senior Manager, GMP/GDP Audits

Robert J. Buta, Jr.



Newton, NJ 07860 · (973) 300-4090 (H) · (862) 432-6177 (C) · rjbuta@mindspring.com



 


Executive Summary


 


A pharmaceutical and medical device quality and regulatory professional with demonstrated experience in managing, and collaborating with, R&D, marketing, technical, scientific and operations staff across multiple projects with a thorough understanding of pharmaceutical development pre-clinical, clinical manufacturing and distribution processes.  Knowledgeable in regulatory affairs, implementation and management of quality systems and compliance operations within pre-clinical, clinical, scale-up, product transfer to third party manufacturing, direct site manufacturing and distribution operations under FDA, ICH, ISO, MHRA and EU requirements.  Experienced interaction with US FDA, MHRA, EU and other regulatory bodies regarding Compliance, Regulatory and Quality issues.


Professional Experience


 


Pharmaceutics International Inc. Hunt Valley, MD                                                         March 2016-October 2016


(Pharmaceutical Manufacturer)


 


Director, Quality Assurance and Compliance


 


Manage all functions of Quality Assurance Compliance for a Contract Manufacturer of Commercial Pharmaceutical and Clinical Trial Material. This incorporates:


 



  • Development and implementation of Quality Systems for Compliance, such as CAPA system management, Investigation Management, Documentation and Deviation Management and Data Integrity of computer systems within Sterile Manufacture/Fill, Highly Potent Hormonal Drug and Solid/Softgel Dosage manufacturing operations.

  • Lead Quality Council with senior management on a monthly basis, with Quality metrics discussed.

  • Responsible for Supplier Quality, Supplier Quality Agreements and external audit of critical suppliers

  • Management of regulatory audits from agencies such as MHRA, Health Canada, EU and FDA and associated responses to observations

  • Management of Change Control Systems, utilizing CAWeb software.

  • Provide guidance on Computer System Validation (Part 11 Compliance)

  • Management of Product Investigations, Customer Complaints, Field Alerts and Recall Activities

  • Responsible for Data Integrity in compliance with regulatory guidelines

  • Responsible for monitoring and review of upcoming regulatory requirements and implementation of strategies to achieve compliance.

  • Implementation of Compliance Metrics, such as CAPA Closure, Quality Event evaluation, Complaint Management,


Investigation closure rates, etc.



  • Direct management of 10 Quality individuals


 


Excellium Pharmaceutical/Leading Pharma LLC, Fairfield, NJ                                                  June 2014- March 2016


(Pharmaceutical Manufacturer)


 


Director, Quality Assurance / Quality Control


Manage all functions of Quality Assurance/Compliance/Quality Control for a Generic Drug Manufacturer and Distributor.


 



  • Development and implementation of quality systems to FDA and ICH guidelines

  • GxP compliance oversight of pharmaceutical manufacturing and laboratory operations.

  • Responsible for Finished Pharmaceutical Product Release.

  • Management of Field Alert Process and subsequent corrective Action (CAPA).

  • Management of  FDA PAI and cGMP inspections allowing for product registration and commercialization.

  • Process, equipment and laboratory method validation management.

  • Developed cGMP Documentation systems and Training program.

  • Management of Stability programs, supplier certification and 3rd party service providers.

  • Developed and manage Change Control and label management processes.

  • Management of continual process improvement within Quality Assurance and Regulatory functions.

  • Documentation Management



Robert J. Buta, Jr.                                                                                                                       Page 2



 


 


Reckitt Benckiser Inc., Parsippany, NJ                                                                                                                2011 – 2014


 


Global Area Quality Compliance Management - North America and Europe     


Managed Quality Compliance Function for Medical Device, OTC consumer healthcare, Sterile and personal care products in US, Canada, and Europe.


 



  • Managed, along with budgetary responsibility, for a direct staff of 16 GxP Quality Managers within Europe and North America.

  • Responsible for management of GLP Quality operations in North America Research and Development Facility utilized for development of global products.  

  • Developed, maintained and improved the Site Quality Management System in accordance with ICH and FDA regulations in regards to medical device, pharmaceutical R&D, manufacturing, supply chain quality and distribution, Consumer Complaints and Pharmacovigilance.

  • Successfully managed Field alert and Recall activities within assigned countries and regions.

  • Managed GxP inspections by domestic and international regulatory agencies.  Developed accepted responses and corrective actions to observions.

  • Managed GMP auditing of primary, 3rd party manufacturers and supplier risk assessment.  Authored International and Domestic Technical Agreements.

  • Management of drug and medical device product release to US Market from direct and third party manufacturers.

  • Secured and maintained ISO registration for medical device (ISO 13485) within international community.

  • Developed and managed GxP training programs.

  • Investigated quality issues, verified root cause, initiated and tracked CAPA through to effective closure

  • utilizing Trackwise software.

  • Planning, co-ordination and hosting of corporate and external inspections.

  • Management of 25 Quality Assurance personnel worldwide


 


 


Excellium Pharmaceutical Inc., Fairfield, NJ                                                                                           2010 – 2011


(Pharmaceutical Manufacturer)


Director, Quality Assurance / Quality Control


Managed all functions of Quality Assurance/Compliance/Quality Control for Generic Drug Manufacturer.


 



  • FDA cGMP and DEA compliance oversight of generic manufacturing and laboratory operations.

  • Responsible for Finished Pharmaceutical Product Release.

  • Management of  FDA PAI and cGMP inspections allowing for product to be registered and commercialized.

  • Process, equipment and laboratory method validation management.

  • cGMP Training

  • Development of Documentation systems

  • Development and implementation of quality systems


 


Independent Consultant, Newton, NJ                                                                                                                 2010


Provided compliance auditing to GMP and GLP requirements for various customers on a contract basis.


 



  • Managed business operations for the receivership (United States Court Appointed) of Azopharma to close and transfer assets of the Azopharma pre-clinical R&D facility in accordance with court directives. 


 


Azopharma Group, Hollywood, Fl; St. Louis, MO; Oxford, NJ                                                                             2007 – 2010


(Contract Manufacturer and Research Organization to the Pharmaceutical Industry)


 


Vice President - Aniclin Preclinical Services / Azopharma Regulatory Affairs 


Chairman - Research Institutional Animal Care and Use Committee (IACUC)


 


Managed operations of pre-clinical facility in addition to developing business opportunities within the FDA regulated industries.   This included responsibilities for quality assurance, personnel, budgetary, scheduling and profit and loss.


 


 



Robert J. Buta, Jr.                                                                                                                       Page 3



 



  • Provided regulatory consultant expertise to clients related to pre-clinical and CMC sections regarding requirements for Investigational New Drug Applications (IND), Abbreviated New Drug Applications (ANDA’s), medical device 510K’s and Common Technical Document (CTD).

  • Managed all FDA, USDA, DEA regulatory audits and client audits, and developed corrective action responses when appropriate.

  • DEA Registered Representative

  • Provided quality assurance consultancy for both internal and external parties.  Ensured successful FDA Pre Approval Inspections (PAI) and Medicines and Healthcare Regulatory Agency (MHRA) audits through management and performance of internal site cGMP compliance audits of manufacturing and laboratory operations.

  • Management of  staff of 35 GLP Quality Assurance, Veterinary and Animal Technicians.


 


Cardiovascular Research Foundation, New York, NY                                                                             2002 – 2007


 


Senior Director, Quality Assurance – Regulatory Affairs


Chairman, SCCR Institutional Animal Care and Use Committee (IACUC)


Directed and managed the Quality Assurance (Clinical and Pre-clinical) and Regulatory functions within the Foundation. 


 



  • Developed and implemented the Foundation’s quality assurance program to ICH GCP standards. This included data management, adverse event management, data safety management board and core laboratory operations.

  • Development and execution of software validation trial data management and analysis.

  • Development and management of vendor qualification and audit program for key suppliers of services

  • Managed and ensured CRO and Clinical Research Site compliance to applicable regulations



  • Directly participated in the design, building and licensure of an AAALAC Accredited (GLP) pre-clinical facility



  • Management of a team of pre-clinical and clinical quality assurance personnel to ensure successful and compliant medical device research trials



  • Manage all FDA regulatory audits and client audits.

  • Provided regulatory guidance and support for obtaining approval to sponsor a phase 4  international clinical trial, (HORIZONS), in addition to multiple other clinical trials


 


 


Consumer Product Testing Company, Fairfield, NJ                                                                                 1996 – 2002


(Contract Laboratory Services to Pharmaceutical and Medical Device Industries)


 


Senior Director, Regulatory Affairs and Quality Assurance                                                                        1996 – 2002


Responsible for all aspects of quality assurance, compliance and regulatory affairs in a FDA regulated contract research organization which performed Pre-clinical, Toxicology, Clinical Safety and Efficacy  studies, Analytical, Microbiological, and Stability to Good Clinical Practices (GCP), Good Manufacturing (cGMP) and Good Laboratory (GLP) practices for  Medical Device, Brand, Generic and OTC Pharmaceutical Product. 


 



  • Release of manufactured pharmaceutical products.

  • Development of site GxP compliance strategies for all functions of the operations.  

  • Management of Quality in Clinical studies to ICH E6 guidance.



  • Responsible for representing the company in all matters involving regulatory agencies, general GxP inspections in addition to PAI inspections.  Experienced in responding to agency observations (483’s).


 


American Technical Consultants, Inc., Yardley, PA                                                                                 1995 – 1996


Senior Consultant                                                                                                                                 


Responsible for the management and leadership of all project staff, project timetables and expenses for regulated industry projects which included:


 



  • International and domestic cGMP compliance auditing of pharmaceutical manufacturing operations.

  • Provided ISO 9000 quality system development assistance,


 


 



Robert J. Buta, Jr.                                                                                                                       Page 4



 


 


Devro, Inc.  (Subsidiary of Johnson & Johnson, Inc.), Somerville, NJ                                                         1991 – 1995


Manager Regulatory Affairs                                                                                                                  


 


 


Professional Affiliations & Certifications


Regulatory Affairs Professional Society (RAPS)   Regulatory Affairs Certified (RAC)  990000505


Certified ISO 9000 Lead Assessor # L-3513


American Chemical Society (ACS)         


Education & Instructing


Bachelor of Arts (Chemistry, Botany), Rutgers University, Newark, NJ


 


Instructor:   University of Wisconsin-Madison, Department of Engineering Professional Development


 


Courses:           


Pharmaceutical Water Systems:  Design, Installation and Validation – 2000 to 2012


Good Manufacturing Practice for Regulated Consumer Products and Dietary Supplements - 2003 to 2012


Establishing Pharmaceutical Stability Programs2005 to Current


 


 


 


Industry Presentations & Publications


Cosmetic and OTC Testing …Beyond Brand Equivalency


Sponsored by Quality Assurance Association         November 13, 2001        Chicago, IL


Pharmaceutical Water System Summit, May 2003, Philadelphia, PA


Sponsored by Center for Pharmaceutical Training, NYC, NY


Azopharma Phase One Express -  2007 – 2010


Various topics included: Pre-clinical, Toxicology, Regulatory Strategy, Pharmacokinetics and Clinical Trial Requirements.   


 


Establishing the Dividing Line:  Is Your Product a Drug?   Robert J. Buta, Jr,  Philip G. Trager and Edward J. Murphy, Cosmetic and Toiletries,  Volume 116, Number 4, pgs 63-66         


Chemical Documentation of the hybrid origin of Solidago x asperula  Giannasi DE, Buta R, Morton G.  1983 American Journal of Botany, 70 115

  • ID#: 137310
  • Location: Newton, NJ , 07860

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