Pharmaceutical Quality Assurance Consultant with Worldwide Experience

Technical Consultant #1057

Forty years of pharmaceutical and biotech industry experience - Production and development environments.
Validation (computerized systems, equipment, processes), pre-acquisition - due diligence, quality assurance, compliance, quality control, research and development, technology transfer and clinical operations.
Small and large molecule and vaccines, (Flu, Anthrax, and Rabies).
International and domestic experience and assignments, (Europe, China and India).
Exit strategy development, tracking and adjustment.
Working with small, medium and large firms, assisting and managing; start-ups, start-overs and providing individual consulting services, of well established organizations.

Sterile Products

Noted clients served: DuPont Pharmaceuticals, Ohmeda Pharmaceuticals, Searle Pharmaceuticals and Aventis Behring.
Marketed product, research and development, pilot plant operations, (product formulation) and technology transfer.
Liquids, emulsions and lyophilized products.
Aseptically filled, terminally sterilized, formulations with preservative systems.
Buffered and non-buffered formulations.
Ampules, multi dose vials, single dose syringes (i.e. Hypak System).
Two container purge/fill/purge (i.e. Cozzoli) and high speed lines (i.e. Strunck and Calumatic).
Manual light inspection and automated equipment (i.e. Esai).
Manual and high speed labeling.
Manual and automated packaging lines.
Sterile facility (and supporting micro lab) design, construction, start up, validation and operation.
Equipment selection, FAT, Installation, start up, validation.
SOP, work instruction and batch record development, implementation and training.

Consulting

Automated systems (general): Selection, implementation, validation, training and go-live assistance.
Enterprise Resource and Planning (ERP - SAP) and SAS (Clinical Data Management) - System implementation, validation, training and utilization: Guided clients during the planning, implementation and go-live transition phases to assure that planning, logistics, data migration and quality management were enhanced.
Quality / quality systems and compliance: Evaluation, enhancement and remediation.

Undisclosed Company, Founder, 2004 - Present

Quality and compliance consulting.
Consent decree auditing and remediation.
SAP Implementation - Quality and compliance oversight.
Sterile and solid dosage form manufacturing subject matter expert.
Project team management: RFP development, proposal evaluation, partner and personnel selection, scheduling, cost estimates and containment, status reporting and presenting, deliverable assurance, SOP's and training - making it all happen.
Compliance auditing: Conducting, reporting, evaluation for regulatory exposure potential, remediation planning and execution project management
Quality systems: Evaluation of status, enhancement suggestions, planning and execution.
Management substitution: Short and long term.
AIP (Application Integrity Policy): Comprehensive data review to assure the integrity of data presented to the FDA, this included:
- Clinical data review.
- Evaluation of data management procedures and processes.
- Analytical data.
- Validation - methods, processes computerized systems.
- All records.

Clarkston Consulting, International Consultant and Project Management, 2002 - 2004

SAP implementation with vaccines manufacturer - focus on quality management (in United States and United Kingdom).
Focus on Clients who manufacture sterile products.
Facilitated a very effective SAP implementation.
Bridging the understanding gaps among SAP / automated system implementation consultants and client quality management, successful alignment of these groups.

KMI/Parexel Consulting, Senior Consultant, 2002

Quality systems evaluation and implementation.
Focus on clients who manufacture sterile products.
Facilitated useful quality system evaluations from which effective remediation plans were developed.
Capability to quickly understand company culture from quality management and business perspectives and then draw the client in to remediation planning that is intuitive to the majority/key players.

Aventis Behring, Marburg, Germany - Sr. Director, Quality Assurance and Compliance, 2001

Remediation planning and preparation for FDA and EU regulatory agency inspections.
FDA inspection host; successful in shaping employees thinking relative to perception of what the FDA is looking for during as inspection of a foreign manufacturer and risk assessment in alignment with the ethics of the pharmaceutical industry.

Duramed Pharmaceuticals, Cincinnati, OH, Vice President Quality Operations, 2001

Generics and NDA.
Staff of one hundred twenty QA, QC and compliance professionals.
Managed preparation for and successful FDA, German MOH and DEA inspections.
FDA Inspection Host.
Guided management towards balance decision making with regards to potential product recalls.
Articulating the facts in an objective and structured manner thereby facilitating appropriate decisions, actions and management of opinions.

Searle Pharmaceuticals, (Monsanto), Chicago, IL, Director, International Quality Assurance, 1997 - 2000

Provided client with manufacturing expertise and FDA experience.
Quality operations for strategic and regional operations in Europe.
International support in: Germany, Italy, United Kingdom and Moscow and Russia.
Managed preparation for successful FDA and other EU regulatory agency inspections.
FDA Inspection Host.
Implemented corporate quality systems into European pharmaceutical operations.
Successful FDA inspections of sites that had minimal or no experience in managing foreign (U.S.) inspections.
Effective organizational and teaching skills.

Ohmeda Pharmaceuticals, Liberty Corner, NJ, Associate Director Validation, 1991 - 1997

Sterile manufacturing, (emulsions), API and biotech manufacturing process validation in Puerto Rico, the U.K, and other European locations.
Subject matter expert during FDA and MCA inspections.
Key input and presentation during PAI and pre PAI relations, complete with perseverance and good communication skills.

Fluor Daniel, Marlton, NJ - Validation Department Manager, 1990 - 1991

Eastman Pharmaceuticals and Sterling Drug, Great Valley, PA, 1988 - 1990

Manager of Quality Assurance and Research and Development.
Small molecule and biotech research operations including, Laboratory operations in the U.S. and the U.K.
Clinical site selection, auditing and routine monitoring, working at numerous two sites: MD Anderson in Houston, TX and Royal Victoria Institute in the U.K.
Motivated non-GMP lab operations to become acceptable to perform marketed product release testing.

Dupont Pharmaceuticals, (Endo Laboratories), Manager, 1972 - 1988

Working in several locations: Garden City, NY, Wilmington, DE and Manati, Porto Rico.
Manager sterile manufacturing operations and manager sterile pilot plant operations.
Marketed sterile products manufacturing, sterile formulation development, technology transfer and formulation trouble-shooting.
Solid dosage formulation.
Packaging line supervisor.
Quality assurance Supervisor.
Key player during transfer of line of sterile products to new facility in Manati, PR.

Other Professional Activities