Michael Schwendiman
Mesa,AZ
Summary
Compliance Manager focused on minimizing company liability by keeping all records, processes and training in full compliance with established standards and legal requirements. Quality-driven and hardworking with proven skills in spotting issues, developing resolutions and implementing corrective actions.
Overview
26
26
years of professional experience
Work History
Director of Quality Management
Community Medical Services
10.2022 - Current
- Responsible for development and implementation of clinical audits, compliance, medical chart reviews within the framework of CMS policies and regulatory compliance requirements
- Conducts quality record reviews to ensure compliance with DEA, CARF, state and federal performance standards
- Facilitates root cause determination and corrective action development with operations
- Follows up on all plans of corrections, external audit results and record requests received from oversight agencies
- Develops a schedule to visit all sites as needed to assist with quality and compliance needs
- Completes site visit reports and facilitates problem solving for issues discovered in a facility
- Assists management team with preparations and ongoing updates for CARF program and administrative standards and CARF surveys at all locations
- Provides timely oversight to all agency plans of correction, quality improvement plans, or related compliance reports
- Remains aware and informed of all oversight agency and regulations
- Suggests policy updates
- Responds to critical incidents on behalf of the agency
- Serves as the first contact for quality of care concerns from oversight agencies
- Provides oversight to all subpoena and government agency requests
- Attends external meetings, such as oversight agencies or payers
- Provides training to operations for compliance or quality management
- Manages quality Management Coordinators, Records Management.
Manager, Clinical Data Monitoring
Caris Life Sciences
08.2021 - 10.2022
- Responsible for management of team of 50 Clinical Data Monitors and Clinical Data Coordinators (remotely located across United States), new and ongoing training of all staff in industry led change/updates of clinical trial activities
- Responsible for initial drafting of study protocols, study contracts and budgets
- Liaison for remote study site startup activities, regulatory submissions, IRB filings
- Investigative site staff training and study contact
- Daily assignment of all staff clinical data auditing/quality assurance tasks for 27 operative remote sites
- Daily reporting of data submission and auditing/quality assurance metrics to the executive team
- Initial draft of Standard Operating Procedures and annual review/revision of company policies
- Member of the study executive review committee: responsible for assessment of additional study protocol opportunities
- Liaison with governmental regulatory agencies (example FDA)
- Quarterly/annual employee review.
Research Operations Supervisor, Compliance Officer & Training Specialist
Ironwood Cancer and Research Centers
10.2018 - 08.2021
- Responsible for operations department management, budgeting, financial analysis
- Budgets and contract negotiation, financial system auditing and accountant training
- Vendor management and training
- New employee training
- Clinical operations auditing, quality program management and CRA/Monitor liaison
- GCP training for clinical staff and Oncologists
- SOP authoring and review
- Currently manages 54 clinical trials and supportive operations team to vet, complete study startup, SIV, PSV and IMV management
- Conducts interim study audits and performs CAPA with department staff and medical (Oncology) staff
- Completes budgetary reviews and contract analysis, PI and Sub-investigator training for all protocols
- Liaises with study CRAs to ensure trial queries are addressed to completion
- Ensures complete study closeout with sponsor/CRO/site teams to ensure clinical data and financial reconciliation.
Regional Compliance Officer/Regional EHS Manager
LabCorp
08.2014 - 08.2018
- Regional EHS Manager: 19-year veteran of EHS Management systems
- Responsible for management of regional safety programs, site auditing and inspection, staff training activities
- Acts as liaison between company and regulatory agencies (i.e
- OSHA, EPA, DEQ, DEP)
- Workman's compensation case investigator
- Completes annual staff/contractor training across 22 states/452 operations locations (client phlebotomy offices, phlebotomy service centers, hospital work groups, STAT labs and regional laboratories)
- Administrating worker injury reduction program; 2016 employee injury metric reduced from 18 (across 22 states) in 2014 to 8 in 2015, further reduced to 2 employee injuries in 2016
- Ergonomic injuries also reduced from 8 in 2014 to 3 employee injuries for 2016
- Completed evaluator assessments with the FAA, FDA, DEQ, DEP, EPA and OSHA within 22 states over the 2015 to 2016 period
- As a result of these inspections there were a cumulative total of zero non-compliances and 2 program specific recommendations
- Regional Compliance Officer, regulatory compliance, staff trainer
- Acting Compliance Director/EHS Director, January 2016 to August 2018
- Regional Compliance Officer, Mid-America Division: ensures compliance to local, state and federal statutes, laws and ordinances pertaining to patient care, HIPPA privacy act and CAP/FDA standards
- Custodian of patient records, specimens and maintenance of pertinent procedures
- Completes facility inspections for assigned geographic work area of 22 states for interim CAP, ISO 9001, 14001 and 15189 and NY State program accreditations and compliance to federal, state and municipal code requirements
- Performs administrative management and laboratory management conferences to address ongoing compliance updates and facilitate corrective action, remediation and effectiveness check review.
Regional Environmental Health and Safety Manager
Tandem Labs (acquired by LabCorp in February 2008)
05.2005 - 08.2014
- Responsible for the management of safety programs
- Staff regulatory compliance trainer at 4 regional laboratories across US
- Regulatory agency liaison (i.e
- OSHA, DEP, DEQ)
- Workers’ compensation case investigator
- Other responsibilities include facilities management, purchasing, Archivist, training coordination, assistant radiation safety officer, and documentation management
- During the 2005 thru 2014 period completed 17 FDA programmed and interim investigations for Phase I thru Phase IV studies with no cited deficiencies
- Completed client inspections annually with > 300 pharma industry auditing teams
- Completed staff retraining in Woburn, MA, West Trenton, NJ, Durham, NC, Salt Lake City, UT and San Diego, CA employee groups
- Completed annual staff retraining on GLP and GCP regulation (Part 11 and Part 58) and EHS/Compliance training.
Tissue Bank Specialist
US Tissue and Cell
01.2004 - 03.2005
- Responsible for donor tissue transplant research, functional design and creation of transplant products to FDA compliance standards
- Equipment sterilization in preparation for surgical transplant procedures
- Created demineralized bone bandage from donor iliac crest bone segments and authored proof of concept and stability/functionality testing for FDA submission in 2004
- Created demineralized bone putty from donor femoral and tibial bone fragments for transplant
- Proof of concept and function testing authored for FDA submission in 2004.
Senior Technician-Inorganic Chemistry Department
DataChem Laboratories
06.1998 - 01.2004
- Responsible for preparation of sample media, analysis and reporting of data, management of hazardous waste materials and documentation
- Provided support for post 9/11 air quality testing as emergency response team support
- Created testing methodology for metals analysis by FLAA Beryllium and Lead) for pilot research program studying beryllium disease/spongiform encephalopathy
- Authored EPA investigative report and presented methodology to the EPA in 2003
- Supported base closure efforts in Rocky Flats, CO and Dugway Proving Grounds, UT by providing remediation testing
- Completed EPA, NIOSH, US Army, US Air Force and US Navy department and numerous non-governmental entities
- Performed organic chemistry explosives research support and inorganic chemistry research support, method authoring and staff EHS training support.
Education
Bachelor of Science - Consumer Economics
University of Utah
Salt Lake City, UT04.2004
Skills
- Customer Satisfaction Focus
- Quality assurance expertise
- Analytical thinking abilities
- Decision-Making Competence
- Process Planning
- Quality Management Systems
- Team Development
- Documentation And Reporting
- Process improvement strategies
- Conflict resolution techniques
- Risk Management
- Operational assessment
- Procedure Implementation
- Root Cause Analysis
- Compliance
- Strategic planning capabilities
- Qualitative Analysis
- Continuous improvement techniques
- Performance Metrics Development
- External quality assessment
- Performance Improvement Programs
- Auditing and Compliance
- Key Performance Indicator development
- Accreditation processes
- Quality improvement prioritization
- Audit plans
- Regulatory Requirements Understanding
- Quality improvement dashboards
- Document control systems
- Quality Management
- Corrective Action Planning
- Strong Work Ethic
- Customer Service
- Attention to Detail
- Effective Multitasking
- Critical Thinking
- Team Collaboration
- Employee Supervision
- Employee Training
- Interpersonal Communication
- Data Collection
- Staff Supervision
- Process Documentation
- Performance monitoring
- Report Writing
- Policy Reinforcement
- Operation Monitoring
- Deadline Adherence
- Budget Preparation
- Business Administration
- Statistical Analysis
- QMS
Timeline
Director of Quality Management
Community Medical Services
10.2022 - Current
Manager, Clinical Data Monitoring
Caris Life Sciences
08.2021 - 10.2022
Research Operations Supervisor, Compliance Officer & Training Specialist
Ironwood Cancer and Research Centers
10.2018 - 08.2021
Regional Compliance Officer/Regional EHS Manager
LabCorp
08.2014 - 08.2018
Regional Environmental Health and Safety Manager
Tandem Labs (acquired by LabCorp in February 2008)
05.2005 - 08.2014
Tissue Bank Specialist
US Tissue and Cell
01.2004 - 03.2005
Senior Technician-Inorganic Chemistry Department
DataChem Laboratories
06.1998 - 01.2004
Bachelor of Science - Consumer Economics
University of Utah