Sterile Injectable and Medical Devices Quality Expert

Expertise

• Quality for small and large volume sterile injectable and medical devices.
• Quality assurance policies for sterile injectable dosage, and product assurance.
• Procedures for out of specification (OOS) results for analytical and biological laboratories for sterile injectable dosage.
• Quality investigation teams to investigate high and medium level deviations to determine root cause, implement appropriate CAPAs and check for CAPA effectiveness.
• New product development and sterility assurance of sterile disposable products.
• ISO 9001 certification.
• Validate syringe filling operations and validation strategies for mixing (compounding), sterilization, packaging as well as technical transfer of new products and methods.
• Management of multi-site quality organizations, nano-technology facility expansions, infrastructure upgrades or modifications, equipment acquisition, equipment installation, validation and new product transfer.
• Establishing, managing and leading the implementation of highly efficient quality systems: Management review, Corrective and Preventive Action (CAPA) and non-conformance process.
• Interacting with the Food and Drug Administration (FDA) and other global regulatory bodies.
• Managing and supporting international facilities located in Switzerland, Germany, India, China and Dominican Republic.

Experience

Undisclosed Company, President and Principal Consultant, 2011 - Present

• Independent Consultant servicing clients in the pharmaceutical, biotechnology, vaccines and medical device fields supporting both the industry and governments.

Hospira Inc., Rocky Mount NC, Site Quality Director, 2008 - 2011

• Established and implemented quality assurance policies for sterile injectable dosage ensuring that product conforms to established specifications, procedures, and government regulations (cGMP) as well as establishing the quality assurance strategy for the facility.
• Developed, recommend and direct the implementation of objectives, goals, policies, budgets and plans for programs and organizational arrangements aimed at the most effective utilization of the quality organization.
• Responsible for approximately 300 quality associates through 7 direct reports, responsible for all quality assurance, quality control and related activities.
• Interfaced directly with national and international regulatory agencies i.e., FDA, EMEA, TGA, and third party clients.
• Led and implemented global corporate procedure for out of specification (OOS) results for analytical and biological laboratories for sterile injectable dosage.
• Organized and implemented highly efficient quality investigation team to investigate high and medium level deviations to determine root cause, implement appropriate CAPAs and check for CAPA effectiveness.
• Led a multi-functional risk assessment project that evaluated all products manufactured at the site (over 300). This project established the road map to the overall approach of the site validation strategy.
• Active member of the site validation steering committee. Active participation in establishing corporate and site validation policies and the site master validation plan.
• Responsible for approving site validation strategies for mixing (compounding), filling, sterilization, packaging as well as technical transfer of new products and methods.
• Implemented lean operating systems in the chemistry laboratory that allowed for a 90% utilization of laboratory resources to assure on-time release of products.

APP Pharmaceutical, Inc., Senior Director Quality Management, 2004 - 2008

• Directed and implemented quality systems programs to assure that sterile injectable dosage manufacturing operations met established and expected quality, regulatory and customer requirements for aseptically filled sterile dosages.
• Directed the quality units located at Ruby St. Melrose Park, IL, Staley Rd. Grand Island, NY, Barceloneta, Puerto Rico, and Barbengo, Switzerland manufacturing facilities.
• Collaborated with Senior Directors of manufacturing in support of manufacturing activities.
• Directed quality management planning activities associated with successful on time validation of facility expansion for new nano-technology process.
• Directed teams in identifying and prioritizing operational opportunities.
• Directed and authorize efforts to develop remediation.
• Directed activities associated with evaluations of processes and results; drive development of continuous improvement projects and programs.
• Participated with company teams to conduct reviews of potential acquisition candidates. Managed/participated in the integration of such acquisitions.
• Active participation in the acquisition of the Pfizer Cruce Davila, Barceloneta plant in Puerto Rico.
• Hired and established current quality management team at the Barceloneta P.R. plant.
• Successful transfer of phase I products into the Barceloneta, P.R. plant.
• Active participation in the acquisition of Astra Zeneca's U.S. portfolio of anesthetic product line.

Baxter Healthcare Corporation, 1987 - 2004

Director Quality Systems - Medication Delivery Division, 2002 - 2004

• Direct quality systems programs, standards, policies and provide quality management support for the Medication Delivery Division business units and plants.
• Quality management representative for oncology cellular therapy business unit.
• Direct development and implementation of divisional quality initiatives such as Management Review, Corrective and Preventive Action (CAPA), non-conformance process.
• Create system design concepts to enhance quality system efficiency and consistency.
• Led teams in acquiring and, or developing and implementing quality concepts.
• Established divisional management review process by creating a new process in compliance with federal regulations. Effectively conducted management review sessions with Medication Delivery Division senior management.
• Established new process and core requirements for divisional personnel training.
• Simplified process by establishing one training procedure.
• Consolidated 17 SOP's into one divisional procedure.
• Created web-based annual refresher GMP training course as a commitment to FDA. This training module was made available to Baxter on a global basis.
• Active participant in divisional CAPA process implementation and played a leadership role in the implementation and training of the new CAPA process.
• Member of the divisional CAPA review board.
• Responsible for managing the field corrective action process.
• Established required links between change control, CAPA, and complaint evaluation process to better assess field corrective action needs.

Quality Manager II - Compass, 2000 - 2002

• Responsible for management and support of 5 remote pharmacy-compounding sterile dosage operations and one sterile combination medical device manufacturing facility.
• Compass pharmacy was an outsourcer for compounded admixtures to institutional pharmacies and as a manufacturer of aseptically filled 0.9% saline and heparin flush syringes.
• Started up a new state-of-the-art schedule II pharmacy compounding facility. This included validation of new compounding clean room and compounding equipment and establishment of an effective quality system. No DEA or FDA findings were made during inspection of facility.
• Successfully validated a new Class 1000 clean room for pharmacy compounding.
• Built a new clean room to comply with New Jersey State Pharmacy Board requirements. No FDA findings during last inspection.
• Validated syringe filling operations; which including validation of new clean room, filling environment, filling equipment, and establishing an effective aseptic filling quality system.
• Implemented efficient quality systems for Compass pharmacy compounding and syringe operations reducing customer complaints 30% and achieving 90% on time product release.

Quality Manager II, 1999 - 2000

• Managed operations at medication delivery's drug delivery facility.
• Quality responsibility included line operation activities across aseptically filled small and large volume sterile dosage of Cephalosporin, Non-Cephalosporin and Penicillin manufacturing cells, quality control chemical and microbiological labs, quality engineering and validation, and documentation center and product release.
• Reduced by 21% finished goods release time by creating and leading a multifunctional team to deal with unexpected situations that might cause release delays.
• Attained better than 90% on time release of finished goods by leading weekly decision-making meetings with a multi-functional team.
• Reduced process non-conformities (exception reports) by 30%. Led the quality team in the identification and elimination of root cause of non-conformities.

QA Section Manager, 1989 - 1993

• Supervised and managed chemical and environmental control laboratories, incoming chemical raw material inspection and testing, document control center, sterilizing process qualification and re-qualification, and technical review for NDA submissions.
• Transferred the divisional stability program from Round Lake, IL to Maricao, Puerto Rico resulting in a $200,000 cost savings.
• Maintained chemical release of finished product at 4 days or better which kept final release of product under 10 days.

Quality Control Section Manager, Fenwal Division S.A., Haina, Dominican Republic, 1988 - 1989

• Supervised and managed in-process testing and release of finished goods, incoming inspection of raw material, document control center, environmental laboratory, PMA technical reviewer.
• Reduced product release time from 34 to 14 days.
• Successful transfer and on time start-up of new product line.
• No FDA 483 on plant's first establishment inspection.

Quality Control Supervisor, 1987 - 1988

• Responsible for QC inspection of in-process and final product, SOP control, environmental control.
• On time start-up of the Fenwal Dominican Republic operations, clean room validations and compressed air validation.

Hudson RCI, Quality Assurance Manager, 1997 - 1999

• Managed a laboratory manager, quality engineer, vendor/product specialist, seven quality technicians, and the documentation center.
• Responsibility included chemical and microbiological laboratories, in-process inspection, quality engineering, vendor audits, document control, and aseptically filled finished goods release.
• Achieved 30% reduction in vendor-related non-conformance due to implementation of a vendor audit program for the Arlington Heights facility.
• Significantly reduced corporate audit findings through implementation of a corrective action follow-up program. No findings in last corporate audit.
• Played leadership role in communicating quality and safety awareness with significant reduction in quality-related issues and no safety-related incidents for 18 months.
• Key contributor to more than $90,000 in successful cost reduction projects

Dentsply International, Midwest and Gendex Divisions, 1995 - 1997

Quality Assurance and Regulatory Affairs Manager

• Responsible for QC incoming inspection, final inspection of finished goods, process improvements, regulatory compliance (FDA), and complaint handling system.
• Supported new product development as well as line extensions of existing products. Responsible for managing a regulatory affairs manager, two quality engineers, and three QC inspectors.
• Implemented the application of quality tools (SPC, FMEA etc.) that resulted in a 40% in-process scrap reduction.
• Implemented process capability studies for CNC equipment.
• Co-Chair Person of the steering committee for ISO 9001 certification.
• No major FDA 483 in last establishment inspection.

Stryker Instruments, Dental and Blood Technologies Division, 1993 - 1994

Quality Assurance Manager

• Managed a QC associate manager and four QA engineers.
• Responsibility included QC incoming inspection, in-process and final inspection, the supplier management program, process improvement, new product development, and sterility assurance of sterile disposable products.
• Achieved successful and on time market introduction of new blood technology product.
• Established environmental monitoring program for clean room operations.
• No FDA 483 observations during last establishment inspection.

Institiuto Technologico de Santo Domingo, (INTEC) Dominican Republic, 1985 - 1987

• Director - Basic Science Department
• Professor of Biochemistry for the School of Medicine.

Honors & Publications

Languages

• Fluent in Spanish

Education

• M.A. Molecular Biology, Johns Hopkins University, Baltimore, MD
• M.S. Biochemistry, Odessa State University, Ukraine, USSR
• B.S. Biology, Odessa State University, Ukraine, USSR