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
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: Manufacturing and Packaging. Pharmaceuticals, Diagnostic Kits, Over-the-Counter medications, Consumer products, Pet products and vitamins.
- PM Engineering Dept.: Investigations
EDUCATION / MEMBERSHIPS
- B.S., International Business / Marketing, Quinnipiac College, Hamden, CT
- Member: PDA, and ISPE