Industry Consultant


  • Senior-level Executive with Operations, Quality and Compliance experience within some of the top Pharmaceutical, Consumer Products, Medical Device, Food Supplements (Human and Pet), Biologics manufacturing companies in the industry.   Demonstrated year-over-year improvements in Operations, Quality, cost, and delivery functions.  Multi-site and Global management experience. 
  • Site Project/Program Manager responsible for Mergers & Acquisitions/Integration projects, Equipment, Tech. Transfer, Process and Cleaning Validation/Qualification Projects, QMS Integration and/or design and implementation.
  • Strong, ethical, and approachable decisive leader.  Excellent analytical, organizational, team building and planning skills.   Uncompromising focus on high Quality and production improvement.  Effective technical and communication abilities
  • Designed and led improved training program that increased production output by 10% and Quality by 5% within first 6 months of implementation 
  • Led the implementation of a quality improvement initiative to track and improve first pass yield from 60% to consistently ranging between 80% and 90%
  • Successfully managed multiple Consent Decree’s, 3 cGMP/Quality and Operations Remediation Projects through Certification.  Successfully managed $15mm Consent Decree C&Q validation / compliance project. Projects consisted of multiple teams consisting of 5-20 people per team.  
  • Managed the Quality oversite of a new Oral Solid Dosage plant.  Conceptual Design, Detailed Design review, Quality system development, Quality oversight of all qualification and validation efforts.  
  • Managed Plant Operations and shaping the departments strategy for innovation and expansion into new technologies: Oral Solids, Liquid, Powders, Inhalation Products, combination products, medical device, Dietary Supplements, Personal Care and Biologics Operations experience.  Controlled Substances. P&L responsibility.  Experience implementing business strategies, plans, procedures, and ability to drive revenue.
  • Fact based decision maker, understands complex issues, and can make informed decisions when working on ambiguous issues
  • Able to make quality/compliance decisions in a business environment
  • Strategic and Forward-thinking attitude towards Production Operations, GMP and regulatory compliance
  • Managed Operations teams >20 Direct Reports and >200 indirect reports.  Project teams >60 direct and Indirect reports.

Core Competencies


Project/Program Management/Strategic Leadership and Planning    cGMP Compliance Remediation

Microsoft Office/Microsoft Project                                                              Process Improvement, Tech Transfer

Trackwise, Kaizen, 5s, Lean Mfg.                                                                  Operating Procedures/Work Instructions

CAPA, Deviations/Investigations                                                                 Training/Training Materials/Assessments

Quality Systems support/Auditing; GMP, PAI                                          Working knowledge of US FDA, EU GMP regulation

Plant Operations and Quality Site Lead                                                      Operational experience in Packaging and Manufacturing


Selected Accomplishments


Consulting Firm – Easton, PA Jan. 2009 – Sept. 2016

Industry Consultant                                                                                                                      Apr 2020 - Present   


  • Clients/Assignments: Working with Multiple Companies and business models within the Pharmaceutical, Biotechnology, Medical Device, Nutraceuticals, Cosmetics, CBD/Hemp and Consumer Products Industries.  Plant Operations, Quality and Compliance, Project/Program Management.
  • Ethicon: Senior Program Manager/Project Manager Quality Systems remediation
  • Isogen llc.: Manufacturing/Operations Quality/Compliance & C&Q Project Facilitator – Plant Manager, Tech. Transfer
  • Schering-Plough:  Global Clinical Supplies Project Manager
  • Merck: Bio/Sterile Validation Department Project Manager; oversight of the C&Q validation of new product.  20 direct reports.
  • McNeil: Senior Project Manager Consultant, Consent Decree Remediation Compliance Management; Operations across multiple domestic and international sites. 15 remediation projects across 3 sites
  • Atrium Innovations: Senior Consultant, Operations and Quality Systems Remediation, Interim Site Quality Director
  • Otsuka Pharmaceuticals:  External Supplier/CMO Site Operations and Quality representative, Person-In-Plant (PIP)
  • Janssen Diagnostics: Operations Product Support.  Implementation Project Manager
  • FlexFab:  Quality Systems review and assess for entering Pharm/Med Device Industries
  • BMS: Mergers and Acquisitions QMS integration SME
  • Ology Bioservices: Quality Systems and Operational support consultant. Reviewed CAPA’s, Investigations and SOP’s.  Worked with Training and QA to develop Clean room training, Investigation’s training and CAPA training programs.


  • Quality Systems Remediation, Auditing.
  • cGMP Consent Decree Management
  • Mergers and Acquisitions (M&A) Due Diligence and QMS Integration
  • External Supplier/Contract Manufacturing Site (CMO); Operations & Quality Site Representative. 
  • Manufacturing and Packaging Batch Record Review, Data Integrity, Serialization.
  • Investigations Review
  • CAPA Review and Tracking
  • Audit Response Process Development and review
  • Operations (Manufacturing/Packaging), Personnel training/qualification and Mentoring
  • Compliance, Quality and Operations oversight.  Operations Process review, improvement & implementation.
  • CAPA review and tracking.
  • Project/Program Manager; M&A, Equipment, Facilities, Utilities, Computer Systems validation/qualification
  • Tech Transfer
  • Covid-19 Remote testing site Quality needs assessment 


The Weinberg Group – Washington, DC                                                                                Sept. 2016 – Mar. 2020

Director of GMP Quality and Operations Compliance Services

(Sold to ProPharma Group and company was reorganized)


Direct oversight and Project Management of the services required to ensure a company’s compliance to all GxP's through a team of Qualified Staff and Subject Matter Experts that help with due diligence that a facility may need. As well as the auditing, design and implementation of all Quality Systems within an organization; Equipment System, Laboratory Controls System, Materials System, Packaging & Labeling System and Production System.  Projects are Domestic and International. 


        Project Management/Oversight/Worked with:

  • Mock audits
  • Audit teams of 1-8
  • Auditing against FDA CFR’s, ISO & ICH guidelines and assorted International regulatory bodies.
  • Quality Investigations, Process and CAPA reviews
  • GMP/GLP Vendor audits
  • Products worked with: Pharmaceutical (OSD, Capsules, Liquids, Powders), Medical Devices, Combination products, Cosmetics, Biologics, Nutraceuticals, Active Pharmaceutical Ingredients (API), Over the Counter (OTC) medicines, Cannabidiol (CBD)/Hemp manufacturing, Cell and Gene Therapy, Consumer Products
  • Pre-Approval Inspection (PAI) Audits
  • M&A Due Diligence
  • Attorney/litigation work-GMP Compliance review and assessment
  • Quality Systems design and remediation
  • Credited with shaping strategy for expansion into international markets 
  • Expanded resource availability to 6 Continents
  • GxP Services grew by 135% 
  • Business Development, Client Management


SCHERING – PLOUGH, Kenilworth NJ                   Sept. 2001 – Dec. 2008           

Manager, NJ Compliance Consent Decree Remediation Program Manager and Senior Project Manager of Manufacturing Technical Investigations

  • Successfully managed $15mm Consent Decree validation / compliance project of new and legacy equipment and utilities as well as computer systems within the Pkg./Mfg. Dept. across multiple domestic and international sites.  55 direct reports.
  • Successfully managed the technical transfer of an MDI packaging line (Nasonex™).
  • Managed Claritin™ Allergy relief move from Prescription (Rx) to Over the counter (OTC) for Operations Department.  
  • Managed CAPA and Customer Complaint investigations associated with Pkg. operations


BEN VENUE LABS (Boehringer Ingelheim), Bedford, OH                                                        Sept. 1999 –  Aug. 2001

Department Manager, ILP (Inspect, Label & Package) 

  • Liquid and Lyophilized products
  • Safety needle/syringes
  • Expanded into new technologies for the inspection of liquid and lyophilized inspection
  • Led the implementation of a quality improvement initiative to track and improve first pass yield from 60% to consistently ranging between 80% and 90%.
  • 3 shift Operation: 20 Direct Reports, +/- 100 Indirect reports


MIKART INC., Atlanta GA                                                                                                                     Dec. 1995 – Aug. 1999

Head of Packaging Dept. Operations / Dir. Corporate Training

  • DEA CII Liquid and Solid dosage
  • Designed and led improved training program that increased production output by 10% and Quality by 5% within first 6 months of implementation
  • Managed a 2 shift Operation 

INWOOD LABS, New York City, NY                                                                                                     May 1995 – Dec. 1995

Assistant Director of Packaging Operations

  • Full P&L responsibility for 2 sites and 3 shifts consisting of approximately +/-100 direct and indirect reports.
  • Led a new plant re-layout to consolidate and enhance packaging operations

CARTER-WALLACE, Cranbury, NJ                                                                                                May 1985 – May 1995

Operations Supervisor


  • Operations Supervisor: Manufacturing and Packaging.  Pharmaceuticals, Diagnostic Kits, Over-the-Counter medications, Consumer products, Pet products and vitamins.
  • PM Engineering Dept.: Investigations



  • B.S., International Business / Marketing, Quinnipiac College, Hamden, CT
  • Member: PDA, and ISPE

Submit the form below to express your interest in this professional.