SUMMARY:

• Experienced project manager, trainer, auditor, customer service and supplier quality support, clinical and research laboratory manager/scientist, with extensive experience in Medical Device, Pharmaceutical, Biological, and Clinical Laboratory, Quality Systems, Regulatory areas.
• This experience includes oversight and remediation of complex CAPA processes for all types of equipment, manufacturing, corporate and laboratory facilities.
• Total Quality Management cGMP, GCP, GLP, QSIT, GAMP - 4, ISO 9000/2000, CFR Requirements
• Corrective/Preventive Action
• Nonconforming product Investigations and resolution
• GXP programs
• Internal and external quality systems and focused audits
• Regulatory and inspectional host
• Clinical trial data analysis/review for submissions
• Total Quality Management
• CE Marking of products for European and Asian export
• European Medical Device Directive (MDD) cGMP, GCP, GLP, QSIT, GAMP-4, ISO 9000/2000, CFR Requirements
• FDA
• Internal and external quality systems and focused audits
• Corrective/Preventive Action
• GXP programs
• Nonconforming product Investigations and resolution
• Regulatory and inspectional host
• Clinical trials oversight and data review/analysis
• 510K submission support
• Total Quality Management cGMP, QSIT, GAMP-4, ISO 9000/2000, CFR Requirements
• Computer system validation
• Process validation
• Good Documentation Practices
• Internal and external quality systems and focused audits
• Corrective/Preventive Action
• Total Quality Management cGMP, QSIT, GAMP-4, ISO 9000/2000, CFR Requirements, FDA, EU
• GXP programs
• Process validation
• Internal and external quality systems and focused audits
• Corrective/Preventive Action
• Quality Manager for manufacturing oversight - Pharmaceuticals
• Manufacturing oversight for all contract/vendors- Pharmaceuticals
• Clinical trial oversight for Pharmaceutical manufacturer
• Facilities support-installation, validation, commissioning of critical equipment and systems
• Total Quality Management cGMP, GCP, GLP, QSIT, GAMP-4, ISO 9000/2000, CLIA, COL, OSHA, Blood borne Pathogens Standards
• FDA, EU, Canadian Regulations
• Internal and external quality systems and focused audits
• Corrective/Preventive Action; initiation, closure, monitoring, documentation via deviation reporting process
• Good Documentation Practices
• GXP programs
• Quality improvement projects
• FDA pre-license, coaching, mentoring, assessments for plasma centers
• Plasma center remediation for compliance/quality processes/manufacturing unexpected events
• Biotech manufacturing processes
• cGMP, GCP, GLP, QSIT, GAMP-4, ISO 9000/2000, CLIA, COL, OSHA, Blood borne Pathogens Standards
• State and National Laboratory Regulatory Requirements
• Internal and external quality systems and focused audits
• Corrective/Preventive Action
• Good Documentation Practices
• GXP programs Regulatory and inspectional host
• Registered Medical Technologist - hands on operation of all clinical laboratory equipment
• Equipment and method validation and commissioning activities

INDUSTRY / PROJECT EXPERIENCE:

Quality, Compliance, Validation and Regulatory Consultant

Confidential

Responsibilities:

• Direct and indirect support of complex non-conformance CAPA investigations which include manufacturing measurement systems, equipment calibration and maintenance, Gauge studies, approved and unapproved supplier non-conformances, testing laboratories (chemistry and environmental)
• Internal and External Audits (including suppliers, labs, storage and transportation of products and supplies for Biotechnology, Pharmaceutical and Medical Device business areas)
• Customer Complaint investigation and resolution
• Technical writing including creation and revisions; policies, procedures, procedures, presentations (including graphics and tables which illustrate tracking and trending)
• Validation investigation and resolutions (equipment, processes and methods) for laboratory and manufacturing facility, process improvements
• Regulatory Submissions and Quality System improvements

Regulatory Manager and Acting Director of Field Quality

Confidential

Responsibilities:

• Directly supervise, mentor, and support the Regional Quality Directors and Corporate Auditors
• Indirectly supervise plasma center Quality Assurance Supervisors and Quality Assurance Technicians
• Recruit and hire field quality staff and Corporate Auditors
• Provide support for Senior Management in growing the business and providing a competent, experienced, well trained Quality staff to support the growth and customer requirements
• Provide for corporate and plasma center staff as required.
• Provide Subject Matter Expert support for the organization specifically (but not limited to) in the areas of Quality, Validation, Compliance, and Auditing.
• Perform internal and external audits as required.
• Provide project management for remediation and new business acquisition.
• Corporate quality representative to the Change Control Board
• Create, review, and approve technical documentation including standard operating procedures, regulatory submissions, CAPA investigations and reports, tracking, trending, statistical reports to senior management.
• Responsible for performing or direct oversight of all CAPA process steps including conducting and documenting complex CAPA investigations (These numbered in the hundreds over a six months span of time).
• Direct use of MasterControl for documentation control, tracking and trending of CAPA activities.

Associate Director

Confidential

Responsibilities:

• Directly supervise large staff of Quality Supervisors, Trainers, and Operational. (Leads (23 Confidential staff)
• Indirectly supervise the New Center Staff from hire date to FDA audit date (currently approximately 100 center staff.
• Recruit and hire New Plasma Center Staff future plasma centers
• Facilitate for new and existing staff the scheduling, travel, deployment, process as well as facility readiness, for 16 new plasma centers ( )for TPR
• Provide support for senior management in growing the business and providing a competent, experienced, well trained staff to support the growth and customers
• Provide Subject Matter Expert support for the organization specifically (but not limited to) in the areas of quality, validation, compliance, and auditing.
• Perform internal and external audits as required.
• Provide project management for remediation and new business acquisition.
• Perform as part of the Risk & Compliance Team for Confidential .
• Provide review and analysis tracking and trending reports to identify systemic issues requiring corrective and preventative actions.
• Responsible for performing all CAPA process steps including conducting and documenting complex CAPA investigations.
• Direct use of the Trackwise data system for documentation and tracking of all CAPA activities.
• Create, review, and approve technical documentation including standard operating procedures.

Director, Quality & Compliance

Confidential, Indiana

Responsibilities:

• Responsible for performing all CAPA process steps including conducting and documenting complex CAPA investigations using a predetermined format and documentation system.
• Four projects in sterile fill facility/manufacturing lines; these projects included liquid fills and lyophilized products (calibrators and controls for laboratory test kits and diabetes instrumentation.
• Provide consultation for a fortune 500 Medical Device Manufacturer, Indiana
• Complex CAPA investigation team activities for five sterile fill facilities including documentation of investigation, problem statements, root cause analysis, verification of effectiveness and closure statements.
• Projects included were aseptic fill finish services, sterile fill syringes (bone cement) and lyophilized vials (bone cement)
• Provide consultation for a fortune 500 Nutritional Food Manufacturer, Worldwide
• Provide CAPA investigation elements, review, documentation and analysis of tracking and trending reports for three projects.
• These projects were for liquid fill and lyophilized containers.
• Provide quality, compliance and regulatory guidance for Confidential management team
• Provide client support by direct and indirect supervision of consultants on engagements.
• Activities were project management and participative or supporting for the following; 21CFR Part 11 compliance remediation, FDA 483 remediation (manufacturing and corporate systems), laboratory method and equipment validation, (Auditor, GXP, Safety), process validation, facility and equipment commissioning, project management, computer software and hardware validation, regulatory and compliance initiatives, auditing (external and internal)
• Regulatory, compliance and quality oversight for all Life Sciences projects
• Provided comprehensive support for all (GXP worldwide) manufacturing
• Clinical trial, laboratory, regulatory and compliance activities (IND and AND submissions)
• Internal and external auditing,
• Vendor qualifications; monitored contractor/vendor performance and compliance
• Customer complaint resolution
• Planned, scheduled, and monitored all manufacturing and distribution activities for clinical trial and drug substance materials. This included the writing and/or approval of quality plans/agreements which defined the quality requirements, product specifications, contractual obligations of the contractor and company.
• Tracking, trending, monitoring contract and vendor activities
• Designated party for all signature approval relating to manufacturing oversight and product release of drug and drug substance
• Represented corporate quality project management.
• Project manager for 21CFR Part 11 and SOX harmonization and remediation; Creation, execution, and monitoring of Information Technology validation activities for all hardware and software as related to regulated activities.

Corporate Quality Assurance Systems Manager

Confidential, North Carolina

Responsibilities:

• Conducted GXP and GMP compliance audits both internal and external (vendors and suppliers); Plasma center and lab investigations, Pre-German and Pre-TAC Audit evaluations
• Acted as Corporate Quality Assurance Representative for GMP Milestone Reviews
• Acted as Corporate Quality Assurance Liaison for Regulatory Agency and Customer Audits
• Directed assessments of processes and systems as required.
• Direct contributor for a complex CAPA project for a sterile fill and manufacturing facility in California (2002) with input including documentation of investigation, problem statements, root cause analysis, verification of effectiveness and closure statements.
• Direct use of the Trackwise data system for documentation and tracking of all CAPA activities.
• Resourced person for miscellaneous CLIA, FDA, QA, QC, Laboratory, Manufacturing, Plasma Centers, and special projects
• Lead Corporate Special Projects as requested
• Maintained ASQ Auditor, Medical Technologist Licensure and other related professional affiliations
• Performed Corporate Quality Assurance Audit/Oversight Functions as directed. This included review and/or initiation of procedural and/or technical remediation as required by auditing observation responses.
• Responsible for Monitoring of GMP, GLP, GCP Practices/Procedures and Regulations through the Corporate QA oversight/audit process.

Corporate Quality Assurance Systems Manager

Confidential, Indiana

Responsibilities:

• Designated Reliability Engineering -Technical Complaint Manager
• Performed System Audits on Medical Device/Reagent/Control systems
• Performed System Audits on Laboratory Equipment/Reagent/Control systems
• Provided support to Customer Service in and troubleshooting products
• Audited various field/in-house trials; i.e. Clinical Trials, Reagent Manufacturing Trials, and Medical Device Trials.
• Provided Active Support for Research and Development Performed Vendor/Supplier audits as requested
• Provided monthly statistical analysis of system failures, Corrective and Preventative Actions
• Represented department at various internal and external meetings and seminars
• Performed testing to obtain various instrument compliance s and European licenses
• Monitored GXP compliance; Good Clinical Practices (GCP) Regulations, QSR, and ISO status through the QA oversight/audit process.
• Performed system testing for 510 K submissions
• Provided product for customers