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Quality Medical Device

Severn, MD
February 19, 2020

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An experienced Quality Compliance professional with a balance of education, technical and leadership ability within the Pharmaceutical, Biotech and Medical Device Industries. An established background in overall Quality Systems including, Quality Engineering/Validation, Compliance Audits, and Process Improvement. Depth of experience in the following:

Medical Device Reporting, Field Actions, Product Recall

Implementation/Validation of Industry Applications

Industry Applications (TrackWise®, SAP, EtQ, LIMS, Empower, Documentum, STATURE, Compliance Wire)

Capital Project Portfolio Management (Capital Expenditure, Resource Planning, Project Management)

BD Quality System Internal Lead Auditor Certification

E2E Process Development and Deployment

Quality Systems Training Module Development, Train-the-Trainer, QS-Wide Training Delivery

AAMI Quality System Regulations Certification

GxP Auditing & Compliance Investigations CAPA & Root Cause Analysis, Quality Risk Assessments Pharmaceuticals (Sterile Manufacturing and Terminally

Sterile Manufacturing sites): ICH, 21 CFR11, 210, 211,803, 806, and 820. ISO9001, ISO13485:2016, ISO14971


Quality Systems Management Consultant April 2019 - Present

Responsible for developing and implementing robust, compliant quality systems processes for clients in the Cosmetic, Pharmaceutical (sterile and terminally sterile manufacturing), Biotech and Medical Device (including Software as a Medical Device) industries while compiling, measuring and analyzing, and recommending process improvements to ensure engrained Quality culture.

JUBILANT CADISTA PHARMACEUTICALS, INC., provides the highest quality generic pharmaceutical products to assist patients in managing their health.

Quality Systems Compliance Manager January 2016 – June 2018

Responsible for quality by continually improving quality methods and processes through collaboration with local and global Business Process Excellence Teams.

Established a strategic direction and direct the development, implementation and execution of effective 21 CFR 11, 210, 211compliant Quality Systems with short and long-range objectives.

Initiated and lean 5S process for GMP improvement to gowning flow and process to ensure safety of products and employees.

Provided guidance and leadership to the Quality Systems Compliance Team (CAPA, Document Control, Complaints, Inspection Readiness, Recall Management, Change Control, Deviation Management, Audit Management and Training).

Ensured potential and existing quality issues are addressed to an appropriate end.

Partnered with the Business Process Excellence Team for the identification and implementation of continuous improvement activities including a review system of effective quality metrics, identifying early trends, and continually evaluating the effectiveness of quality information streams.

Designed and developws training items (for procedural documents, eLearning, on-the-job, instructor-led) to ensure personnel development and/or increase organizational effectiveness for GMP processes.

Delivered training and/or support local Subject Matter Experts providing training, as needed. Including, GMP Orientation, Train-the-Trainer and routine GMP training courses.

Planed, defined, and directed the site auditing control program to ensure compliance to all procedures and policies to ensure compliance to GMP standards.

Integrated and cultivated a culture of Engrained Quality across the site.

Ensured departmental performance meets the expectations of customer (internal and external) and support of business goals.

Served as Compliance Liaison to Corporate Quality Compliance to ensure the alignment with company’s Corporate Quality Management System.

ROCHE CAROLINA, INC., one of the world’s leading research-focused healthcare groups where success is built on innovation, curiosity and diversity.

Quality Systems Technical Manager April 2013 – January 2016

Responsible for actively contributing to the development and implementation of Policy/Standard Operating Process / Procedures in supporting regulatory requirements for application in execution Pharmaceutical Quality System (PQS) for functions impacted within the Roche/Genentech Drug Substance Small Molecule 21 CFR and ICH compliant organization.

PQS Site Business Process Manager: Proactively develops and manage changes in controlled processes and procedures as the organization evolves, industry practices change and/or regulations change to assure high quality standards with applicable laws, regulations, guidelines and Roche policies.

Discrepancy Management System Site Business Process Manager: Ensures executing the process as designed. Guide the process implementation and process changes at the site/unit and provide ongoing support (first line) to business areas. Monitoring and trending of the discrepancy Management process performance to ensure that it meets customer needs and to foster continuous process improvements.

CAPA Management Business Process Owner for CAPA Continuous Improvement Conference in Basal, Switzerland.

Provided support for SMEs for Annual Product Quality Review.

Served as a key contact for communicating controlled document and policy changes within/across the Roche Carolina organization.

Served as team member for cross-functional site governance team with the purpose of managing the Site Portfolio and Capital Assets (Global Capital Budget and expense budget).

Participating member or the Daily Operations meeting for resource and production planning.

Provided support and guidance during and following internal audits and external regulatory inspections. Support the internal inspection management program by serving as Lead Auditor for internal audits.

Developed QS Training Modules and facilitated site-wide Annual Good Manufacturing Practices (GMP) Training, Quality System processes (CAPA, Discrepancy Management, Change Control) Training and Lead Internal Auditor Training.

Monitored the impact and effectiveness of training solutions; evaluated training Quality System programs & processes through LMS data, the development of surveys and other feedback mechanisms. Interpreted data/feedback, discussed with stakeholders, and suggested improvements to further enhance learning program effectiveness and sustainability.

Served as Subject Matter Expert (SME) on business initiatives involving systems, processes, procedures, regulations (CAPA, Discrepancy Management, and Change Control) and system tools (TrackWise) intended for use compliance and continuous improvement activities.

Provided regular updates to senior management functions and participate in the resolution of quality issues by fostering effective interdepartmental and cross-functional relationships.

Organized and facilitate Site Quality Department Team Builders.

BECTON DICKINSON: DIVISION: WOMENS HEALTH AND CANCER, a medical technology company that manufactures medical supplies, devices, laboratory equipment and diagnostic equipment.

Quality Systems Specialist April 2011 – April 2013

Responsible for sustaining the development, implementation, and improvement of an effective 21 CFR 820 quality system designed to meet appropriate Business, Division, Corporate, Government, and international standards for efficacy, safety, and quality.

Ensured programs are consistent in complying with FDA Quality System Regulations (QSR), ISO 13485, ISO 9000, JPAL (and similar) standards for all of BD Diagnostics - NC's IVD and/or medical device products.

Developed and delivered site-wide compliance and Quality System training for BD Diagnostics - NC.

Developed and promoted continuous quality improvement activities through effective utilization of the CAPA system as well as direct involvement in all situation analysis processes.

Hosted and participated in external audits by regulators, notified bodies, or third party auditors.

Supported facilitation of Quality System Management Review meeting to support the management review process.

Ensured effective and compliant field action decisions and oversee the execution of the action for Medical Devices. Ensured MDR, Vigilance and Canadian reporting requirements are met per 21 CFR 803 and 806.

CAPA Remediation (Consultant) January 2011 – April 2011

Responsible for performing activities required for investigation, implementation and effectiveness checks associated with the CAPA program. Coordinated CAPA systems to ensure corrective/preventive measures are documented, implemented and measured for effectiveness. Verified the implementation of the policies and procedures described in the documented quality system related to CAPA. Impelled CAPAs to closure through performance of effectiveness checks, which include focused internal audits, data analysis and observation of operations.


Quality Systems Consultant May 2006- January 2012

Responsible for developing and implementing robust, 21 CFR 11, 210, 211, 820 compliant quality systems processes to clients in the Medical Device, Pharmaceutical (sterile and terminally sterile manufacturing) and Biotech industries while compiling, measuring and analyzing process improvements.

Ensured compliance with national international quality standards and validate all system components per FDA guidance. Supervised and lead the Quality organization to identify, develop, and implement best quality practice. Supervised all creation and implementation of procedures, master documents, reports, and other controlled documents.

Collaborated with company leadership to establish quality and performance objectives, budgets and forecasts and manages all actives to ensure these objectives are met. Managed performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Coordinated activities during GxP product and process audits; prepared inspection instructions, systems and procedures to ensure audit results are incorporated as required. Investigated non-conformances and analyzed causes of defects and provided recommendation of corrective actions for issues raised during GxP audits and compliance investigations.

Managed the planning and execution of all critical success factors within the project, i.e. scope, time, cost and quality. Coordinated validation projects throughout the entire life cycle - from proposal to final project handover. Assured that product and process validations meet regulatory, local, and corporate requirements. Developed Validation Plans and Maintained Master Validation Plan: Develop and execute IOPQ Protocols. Participated in new product and process development to assure Validation is addressed and arranges the QA tests required by the Validation protocols.

Developed a system for tracking, filing, and maintaining the list of Approved Suppliers. Maintained and supported ongoing assessment processes for service providers. Assigned criticality for all service providers; Evaluated probable vendors to be audited. Conducted GxP audits of the functions within the Operations Compliance organization and prepared reports of the audit findings for distribution to responsible personnel and management.

Performed incident investigations and root cause analysis to identify compliance and/or other failures and establish an agreed upon corrective action plan to resolve identified issues. Documented and tracked CAPAs and CAPA action items to completion. Prepare Quality System reports, including corrective actions and Quality Incidents. Interfaced with internal and external (to US Site Ops) customer departments during all phases of, investigations and CAPA implementation. Maintained GMP, GLP and GCP audit documentation for internal/external audits as well as CAPA.

Provided training and technical assistance as requested/needed by teams such as development, maintenance, and reporting of Key Performance Indices (KPIs). Develop and deliver training sessions and/or components of training as directed and make presentations and/or assist in making presentations and coordinating group activities during training.

Assured that no product is released until its quality has been held in accordance GCP, GLP, and cGMP and other applicable regulations. Conducted audits of the functions within the Vaccine Development Department and prepared reports of the audit findings for distribution to responsible personnel and management. Conducted investigations and corrections for incomplete/unexplained issues found during the record review process. Tracked and ensured completion of corrective actions resulting from record issues assist with the trending of issues not requiring an investigation or Non Conformance Report.

LEINER HEALTH PRODUCTS, a lean manufacturer of vitamins, mineral supplements, and OTC drugs sold primarily under private labels, including Wal-Mart and Costco.

Quality Assurance Specialist May 2001 – May 2006


Livingstone College, Salisbury, NC, “In the Business of Producing Leaders.” B.S., Biology

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