Executive Profile

Published Expert “A New Quality Approach to Reducing Vascular Access Infections” in the Nephrology Nurses Journal as a national Continuing Education Unit (CEU) for Nursing.

Achieved 95% or greater in organizational and departmental evaluations and accreditations.

Leader in Process/Performance Improvement and Cost Reduction strategies.

Published Four Pinnacle Award performance improvement projects through Health Care Association of New York (HANYS) Profiles in Quality and Patient Safety.

End Stage Renal Disease (ESRD) Network Quality Champion Award received from the Centers for Medicare and Medicaid for the “Most Improved Fistula Rate with Outstanding Results”

Five (5) distinguished Military Achievement awards for excellence.

Professional Experience

Bryant Ranch Prepack (Pharmaceutical), Burbank, CA 04/15/2022-Present

Compliance and Regulatory

Designed new organizational label for branding make over.

Developed a cleaning validation for hazardous drug production.

Ensures the proper preparation and coordination of resources needed to achieve regulatory compliance related to all functions within the organization.

Expert in regulatory compliance and regulatory standards,

Co-chaired Quality Committee related to performance improvement, to include the collection, analyses, reporting and on-going monitoring of quality and safety data needed to meet accreditation requirements.

Quality Improvement and Data Analytics develops, monitors, and effectively regulates departmental budgets.

Serves as a catalyst and mentor for motivating productivity, innovation, improvement, high employee morale and commitment to the organization.

GSMS (Pharmaceutical), Camarillo, CA 06/15/2020-03/25/2022

Quality Systems

Ensures Quality System policies, procedures and performance conforms to regulatory requirements, standards, and guidelines of the DEA, FDA and other pharmaceutical regulatory agencies.

Owns and leads quality system processes performance and improvements; including, but not limited to, Management Review, Product and Customer Complaints, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, Deviation reporting and investigations, Corrective Action and Preventive Action (CAPA)

Works directly with internal and external suppliers and customers to ensure quality system requirements are met.

Performs internal audits and inspections, including writing of audit report and presenting to upper management. Responsible for adherence to audit timelines and reporting.

Assists with external audits of suppliers as needed.

Responsible for managing customer and regulatory audits and inspections, including audit/inspection response and tracking.

Leads recall related activities for customer communication, product returns and FDA reporting.

Prepares and presents quality system performance reports to senior management.

GSMS (Pharmaceutical), Camarillo, CA 02/24/2018-06/15/2020

Promoted to Quality Engineer

Collaborating with cross functionally with other areas such as Packaging, Corporate Development, Marketing, Compliance and Engineering.

Resident expert, providing guidance and direction within areas of Pharmaceutical Stability, Validation, Change Control, Deviations, Technical Writing and high-level data analysis.

Data Analysis and Process Improvement Subject Matter Expert.

Develops Corrective and Preventive Action plans throughout the organization.

Determines equipment qualification, process validation, and product line design/modifications requirements.

Focuses process improvement on installation and maintenance of inspection and testing procedures, packaging materials, components specifications and regulatory requirements.

Packaging final product and kitting GMP materials.

Responsible for Manufacturing and Quality Engineering to provide feedback to packaging and production personnel for improved process flow.

GSMS (Pharmaceutical), Camarillo, CA 02/24/2018-02/22/2019

Pharmaceutical Regulatory/Compliance

Develops reports for submission to DEA, FDA, state and local agencies.

Solely responsible for the reduction of cost (Greater than $9,000.00 monthly) by internalizing the FDA submission process, bypassing the third-party vendor.

Controlled Substance lead for Risk, Evaluation, Mitigation Strategy (REMS) program.

Perform regulatory research to obtain relevant histories, precedence and develops policies and procedures to ensure organizational efficiency.

Evaluates and communicates all regulations and current regulatory environment as it pertains to labeling.

Point of contact and develop relationships with points of contact at the FDA on specific product assignment.

Strong working knowledge with FDA cGMP regulation and documentation practices.

Documents and communicates details correspondence of FDA interactions for the organization.

Streamlined the SPL submission process to eliminate waste and increase efficiency by reducing submission time by 250%. (5 days reduced to 2 days)

Responsible for Pharmaceutical/Medical correspondence and reporting.

Bakersfield Behavioral Healthcare Hospital, Bakersfield, CA 07/31/2017-12/06/2017

Bakersfield Behavioral Hospital is a 90-bed acute mental health hospital in Bakersfield, CA.

Director of Quality, Risk and Compliance

Conducted daily organizational meeting to focus leadership for daily milestones and aided in eliminating barriers to routine events.

Developed Plan of Corrections for county, state and federal agency when needed.

Mitigated risk throughout the hospital daily utilizing data analytics.

Proven expert knowledge in redesigning hospital processes and procedures.

Develop new policies to ensure compliance with all agencies.

Sierra View Medical Center, Porterville, CA 05/ 2016-02/27/2017

Sierra View is a 168 bed Acute Care rural hospital in Porterville, CA.

Director of Quality/Risk/Patient Safety/Accreditation

Conducted an outstanding Joint Commission survey with 22 minor deficiencies reduced from 40+ in previous years.

Organizational expert in validating of all hospital data that influences reimbursement.

Managing the Risk, Performance Improvement, Accreditation and Patient Safety departments.

Created strategic plans and instructed the operationalized development of those plans.

Developed and managed the operational budgets of the Risk, Quality Patient Safety and Accreditation departments.

Identified Population Health metrics for the institution of the new state driven PRIME project.

Vibra Hospital, Folsom, CA 11/ 2015-05/2016

Vibra is a 58 bed General Long Term Acute Care hospital (LTACH) in Folsom, CA.

Interim Director of Quality/Risk/Compliance

Reports to the CEO on all issues related to Quality, Risk and Compliance.

Interim Case Management Director during lapse in departmental oversight.

Compliance Officer for Joint Commission and state surveys.

Responsible for Root Cause Analysis to the Department of Health on all adverse occurrences and Sentinel Events as well as Complaints and Grievances.

Responsible for Healthcare Failure Modes Effects Analysis (HFMEA) as required by Joint Commission.

LTRAX oversight administrator.

Provides correspondence with all state, federal and local regulatory agencies.

Attending Cal University Doctoral Program, Irvine, CA 01/2015-11/2015

Gold Coast Health Plan of Ventura County, Ventura, CA 09/2014 -11/ 2014

Gold Coast is an independent public entity governed by the Ventura County Medi-Cal Managed Care Commission and serving 168,000 Medi-Cal beneficiaries in Ventura County.

Interim Quality Improvement Director

Revamped the Quality Management Department that included hiring 3 Data Analysts, a Quality Oversight RN and Administrative Support.

Revised the QI program, its evaluation and work plan, and presented for review and approval.

Developed quarterly QI activity progress reports by tracking and trending the organizational dashboard.

Developed/revised QI policies and procedures for Medi-Cal and Medicare programs, such Disease Management Reporting guidelines for providers.

Utilized quality informatics, metrics and quantitative analytics to identify areas for quality improvement activities and to measure the outcomes of interventions based on HEDIS results.

Monitored/reported to the QIC on quality improvement activities based on HEDIS measures and plan needs.

Collaborated with regulatory agencies, such as Health Services Advisory Group, Department of Healthcare Services.

Provided strategy deployment, systems development, workflow development, ongoing operational compliance, and consistent delivery of results and metrics in the areas of oversight.

Consistent operational compliance and reporting to satisfy and exceed state and federal standards.

Accountable for budget planning and adherence.

Interface with all internal departments to ensure compliance with the QI program and policies and procedures as they relate to case management and utilization management.

Streamline the credentialing and re-credentialing processes, including facility site reviews and physical accessibility requirements to facilitate the increased number of providers.

Directed Organizational staff to act as a liaison with delegated health networks and physician medical groups, ancillary providers and facilities regarding clinical quality issues.

Coordinate activities with Compliance and Audit and Oversight areas.

Developed and presented reports and facilitate review and action by the QIC, QI Work Committees, Joint Operations Meetings, Policy Review Committee, Compliance Committee and Quality Assurance Committee.

Supervised and evaluated QI department personnel.

Interfaced with the CMO and Human Resources regarding department personnel management issues.

Increased the QI staff by 130% by recruitment and retention of competent staff to execute upcoming operational plans.

Developed the Potential Quality Issues (PQI) database for tracking and trending quality issues based on systems, outcomes and provider compliance.

End Stage Renal Disease Network 18

Health Services Advisory Group (HSAG), Glendale, CA 11/2009 to 3/2014

Formerly Southern California Renal Disease Council Inc, Los Angeles, CA

The External Quality Review Organization (EQRO) and former Quality Improvement Organization for California, HSAG is contracted to provide quality oversight for Dialysis facilities, Managed Care Organizations other healthcare clinics and hospitals.

Director of Quality Improvement

Responsible for Quality Oversight for all Healthcare Clinics to ensure CMS, DMHC, CDC and other agency guidelines and requirements were met throughout southern California.

CMS “Grant Reviewer” for the Innovative grant approval team.

Established onsite training and education for healthcare organizations throughout southern California.

Former Chairman of Marketing and Communications for national Fistula First Breakthrough Initiative.

Former Chairman of the Internal Review Committee for Southern California Renal Disease Council.

Former Western Region ESRD Lead Quality Improvement Director for the 11 western states.

Developed education materials for Medical Directors with regards to Conditions for Coverage and other CMS Policies and initiatives.

Oversight for NCQA focused initiatives.

Collaboration with several Organ Procurement Agencies.

Presented a “Psychonephrology project” at the CMS sponsored QualityNet Conference.

Resident Expert on NHSN, CrownWeb, PPS, QIP, HAI, ICH CAHPS and other CMS initiatives.

Prepared contract proposal for CMS government contract.

Developed regional policies and procedures to align all dialysis facilities in southern California.

St. Mary’s Hospital, Amsterdam, New York 2/ 2006 to 1/2008

This Ascension Healthcare group facility is an acute hospital with 280 beds and multiple ancillaries throughout New York.

Clinical Project Manager

Created a Surgical Risk Assessment policy for Ambulatory care. Reduction in Birth trauma and several other projects that were published in Health Association of New York’s (HANY) Profiles of Excellence/Quality and Patient Safety.

Provided quality process improvements for all departments of the 120-bed acute hospital and ancillaries.

Monitored and improved all CORE measures throughout the hospital and ancillaries.

Directed Surgical Care Improvement Project initiatives, increased the overall scores by 17%.

Developed annual Failure Modes Effects Analysis as required by Joint Commission

Approved St. Mary's submissions of Root Cause Analysis to the Department of Health on all adverse occurrences and Sentinel Events.

Conducted periodic Healthcare Failure Modes Effects Analysis (HFMEA) with subsequent implementation of risk strategies to the Health Department (DOH), Joint Commission (JCAHO), and Centers for Medicaid and Medicare Services (CMS) for the entire organization.

Streamlined Emergency Room flow-through as well as Operating Room capacity analysis.

Instrumental in the system analysis and approval of the Electronic Health Record (EHR).

Developed the Emergency Response team that reduced hospital codes by 26%.

Instrumental in the standardization of hospital protocols and policies.

Designed systems and reports for quality improvement, including credentialing, readmissions, adverse events and other quality management reports.

Self-employed Consultant 2003-2006

Provided consulting services to healthcare, manufacturing and aviation businesses in the New York area.

Process improvement, financial and operational consults.

U.S. Navy 1986-2003

Operations Chief

Began my career in an entry level role and rapidly progressed to middle management and was deployed on variety assignments globally. In charge of Operations Chief Auxiliary Security Force with oversight for 250 service members. Majority of positions were in Operations, Quality Management and Risk Stratification.

Education

Master of Business Administration (MBA), 2007

American Int. University - Hoffman Estates, IL, USA

Bachelor of Business Administration (BA), 2005 Ohio State University/American Int. University - Columbus/Hoffman Estates, OH/IL, USA

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