Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional with years of Project Management, Operations, Compliance, and Validation experience within major Pharmaceutical, Consumer Products and Biologics Manufacturers with demonstrated year-over-year improvements in quality, cost and delivery functions.  Broad experience as a strong, ethical, approachable, decisive leader, with excellent analytical, organizational, team building and planning skills. Consultant with effective technical and communications skills, displaying an uncompromised focus on high quality and production improvement. Background successfully managing multiple Consent Decrees, 3 cGMP/Quality and Operations Remediation Projects through Certification as Site Project/Program Manager responsible for Equipment, Process and Cleaning Validation/Qualification Projects for Oral Solids, Liquids and Biologics Operations.

CORE COMPETENCIES

  • Project/Program Management
  • Strategic Leadership and Planning
  • Microsoft Office/Microsoft Project
  • Trackwise Electronic Systems
  • Kaizen/5s/Lean Manufacturing
  • CAPA/Deviations/Investigations
  • Quality Systems/Quality Auditing
  • Technology Transfers
  • cGMP Compliance/Remediation
  • Process Improvement/Quality Improvement
  • Operating Procedures/Work Instructions
  • Training/Training Materials/Assessments
  • FDA 21CFR Parts 3/4/11/210/211/803/820
  • Packaging/Warehouse/Distribution Operations
  • Validation Management/IQ/OQ/PQ
  • Supply Chain Operations

SELECTED ACCOMPLISHMENTS

  • Managed projects as Implementation Specialist that interfaced with multiple organizations both internally and with external partners, including:
    • Ensured alignment, prioritization and maintenance to schedule.
    • Managed technology transfer of diagnostic test kit.
  • Managed  project for bio-sterile validation for major pharmaceutical manufacturer, including:
    • Developed and maintained project schedules for department engineering projects.
    • Reviewed/edited validation protocols for technical and compliance requirements.
    • Managed/participated in validation protocol upgrading project and product extension validation (clean room experience).
    • Managed resources (25 engineering validation consultants).
    • Managed $3mm validation project.
    • Oversaw and negotiated change orders as required and new project proposals.
    • Set-up and lead weekly departmental project scheduling meetings.
    • Proactively monitored and reported progress to the department’s Associate Director and Project Team against project plan to ensure deliverables were on time and costs were within budget.
  • Managed supply chain that supplied specific demands for assigned clinical trials as global clinical supplies project manager, including:
    • Negotiated with internal supply chain groups: Clinical Manufacturing, Packaging, Regulatory Affairs, Contract Research Organization outsourcing, and PharmSci Quality.
    • Maintained close communication with appropriate ‘customers’ representative regarding international requirements, clinical study forecasts, timelines, resource capacity constraints, and drug supply.
  • Project managed quality/compliance for technology transfer on new Science Center for start-up Bio-Tech Clinical Phase 1 to 4 contract manufacturer, ensuring that all projects met timeline and adhered to GxP requirements, including clean room requirements.
    • Helped design, draft and implement GxP training program, safety training program, preventative maintenance program, and waste stream management program.
    • Drafted operating procedures for: water for injection (WFI), clean steam system, unidirectional airflow systems and pre-treatment water system.
    • Drafted qualification document for unidirectional airflow systems.
    • Help design vial/syringe inspection and packaging program.
    • Facilitated and managed clients’ products/projects through facility and technology transfer.
    • Compliance/quality reviewed, edited, and approved all engineering qualification documents for site.
    • Drafted qualification document summary reports and project time lines.
  • Developed and managed remediation project plan to meet new regulations for combination products as Senior Project Manager, including:
    • Identified and analyzed issues affecting project.
    • Monitored ongoing progress of key deliverables against plan goals, including identification of potential risks and contingency plans.
    • Mentored team members in compliance remediation.
    • Communicated progress of project deliverables to teams and Senior Management.
    • Conducted CAPA Tracking and review.
  • Developed and managed required major process steps toward consent decree remediation deliverables concurrence for Warehousing, Distributions, Shipping, and SAP and Materials/Components As Senior Project Manager, including:
    • Managed 34 projects and approximately 100 project team members across 2 solids and liquids manufacturing sites, utilizing process excellence tools.
    • Developed, enhanced, and implemented mechanisms to track and report on remediation work plan progress
    • Managed gap analysis and remediation of procedures and standards to regulatory findings.
    • Facilitated and drove teams based upon accountability to achieve robust and sustainable processes.
    • Managed project plan development and management with project status updates and progress reporting for 2 manufacturing sites.
    • Drove cross-functional teams to resolve issues.
    • Conducted “As-Is” and “To-Be” Process mapping.
    • Managed auditing of new processes for sustainability.
    • Identified and analyzed issues affecting project.
    • Facilitated achievement of goals for project plan.
    • Monitored ongoing progress of key deliverables against plan goals, including identification of potential risks and contingency plans.
    • Communicated progress of project to teams and Senior Management.
    • Mentored team members in compliance remediation.
    • Project/program managed certification re-start (Warehousing, Distribution, SAP and Materials/Components) on new liquid production facility.
  • Acted as single point of contact for all technical and quality-related activities at external supplier as external supplier/site auditor, including:
    • Audited processes to ensure cGMPs were properly executed for combination products, medical devices, and liquid biologics.
    • Managed all manufacturing investigations and CAPA reviews.
  • Identified/reviewed/edited quality systems and procedures and remediated to current FDA 21CFR Parts 111/210/211 and EU Part II for quality systems and manufacturing, packaging operations, and compliance remediation, including:
    • Mentored in Quality Compliance, as change agent in Quality, Packaging, Manufacturing, Facilities and Warehouse operations.
    • Conducted supplier quality audits.
    • Remediated deviation/investigations, CAPA, audit tracking, GDP, facilities and ERP systems SOP’s.
    • Acted as interim site quality manager/lead at pharmaceutical manufacturer (developer and manufacturer of liquid filled capsules).
    • Participated and helped manage regulatory agency audits.
  • Managed $15MM consent decree validation/compliance project for new and legacy equipment, utilities, and computer systems within Packaging/Manufacturing areas, including:
    • Managed technical transfer of packaging line.
    • Managed CAPA and customer complaint investigations associated with packaging operations.
  • Project managed packaging and labeling of liquid and lyophilized products, syringes, and DEA CII liquid and solid dosages pharmaceuticals.

PROFESSIONAL EXPERIENCE

  • Acro Staffing Inc., Contract Implementation Specialist, (Livonia, MI) – January to March 2016
  • Otsuka Pharmaceuticals, Contract Ext. Suppl./CMO Auditor (Princeton, NJ) – July 2014 to March 2016
  • Atrium Innovations, Contract Senior Consultant (Pittsburg, PA) – March 2015 to September 2015
  • Ethicon, Contract Senior Program Manager (Somerville, NJ) – December 2014 to March 2015
  • Solution Systems Inc., Contract Senior Project Mgr. Consultant (Narberth, PA) – November 2011 to December 2014
  • Valsource, Contract Program Manager (Downingtown, PA) – October 2009 to October 2011
  • Schering-Plough, Contract Global Supplies Project Mgr. (Summit, NJ) – August 2009 to October 2011
  • Isogen, LLC, Contract Program Mgr., Tech Transfer (Newark, NJ) – January 2009 to July 2009
  • Schering Plough, Consent Decree Program Mgr. (Kenilworth, NJ) – 2001 to 2008
  • Ben Venue Labs, Dept. Mgr. ILP (Bedford, Ohio) – 1999 to 2001
  • Mikart Inc., Mgr. Packaging/Director Corporate Training (Atlanta, GA) – 1995 to 1999
  • Inwood Labs, Assistant Director Packaging (New York, NY) – 1995

EDUCATION

  • B.S. International Business/Marketing, Quinnipiac College, Hamden, CT – 1994

AFFILIATIONS

  • Member IOPP, PDA, ISPE