SKILLS AND COMPETENCIES:

Fluent in English and Spanish (speaking native speaker, reading, writing and presentation)

COMPUTER SOFTWARE SKILLS:

• Proficient in Microsoft Office Suite (Outlook, MS Excel, PowerPoint, MS Word, Visio), and Adobe Acrobat Professional.
• Proficient in electronic systems used in clinical trials including Electronic Data Capture (EDC) Systems (i.e., DataLabs Perceptive, Inform Oracle, and Rave Medidata ); Electronic Trial Master File (i.e., Veeva Vault and other in - house systems); SharePoint.

EMPLOYMENT:

Confidential, Saint Charles, IL

Quality Assurance Good Clinical Practices (GCP) Auditor and Consultant; Business Manager

Responsibilities:

• Planning, leading, and conducting reviews, assessments and audits of domestic and international clinical research trials against applicable GCP regulations and guidelines (FDA, EMA, and local requirements; ICH Guidelines), standard operating procedures (SOPs), and Good Documentation Practices (GDP; ALCOA) for a variety of clients/sponsors.
• Reviews and audits of clinical trial and regulatory documents including study protocol, informed consent form (ICF), case report form (CRF), clinical study report (CSR), clinical sections of the Common Technical Document (CTD/eCTD, mainly Modules 2 and 5), Summary of Clinical Efficacy (SCE), Summary of Clinical Safety (SCS), Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and Investigator’s Brochure (IB).
• Conducting audits of the Trial Master File (TMFs; electronic eTMF, paper and hybrid systems), Investigator Site File (ISF), Investigator Sites, For - Cause Audits, Clinical Database, Data Management, SOPs and policies, and Quality Management Systems related to GCP operations.
• Providing training and support to sites for Inspection Readiness and Management.
• Reporting of findings and potential concerns to auditees and clients/sponsors, both through verbal presentations and written audit reports; escalate significant findings as required by the client/sponsor.
• Reviewing responses of audit findings for appropriateness and completeness; following up with auditees until agreed closure/completion of responses.
• Therapeutic areas: Cardiovascular, Dermatology, Endocrinology, Nephrology, Neurology, Oncology, Psychology/Psychiatry, Urology and Vaccines.
• Proficiency in electronic systems including Electronic Data Capture (EDC) Systems (i.e., DataLabs Perceptive, Inform Oracle, and Rave Medidata ); Veeva Vault; SharePoint.

Confidential, Abbott Park, IL

Humira Global Change Control Director

Responsibilities:

• Management and maintenance of a global quality system of change control to ensure compliance to market requirements for the global manufacturing process of Humira, a biopharmaceutical product.
• Management of a cross-functional team to execute reviews of all changes included membership from Quality Assurance, Regulatory Affairs, Manufacturing Operations, Manufacturing Science & Technology, and ad hoc members as needed (e.g., Statistics, Safety, Medical Operations, Research & Development, and Marketing) from domestic and international sites.
• Reviews of planned and unplanned changes (i.e., documents, deviations and nonconformances) affecting Drug Substance and all finished drug product to evaluate impact on product quality, assess corrective/preventive action plans (CAPA), and ensure compliance to corporate requirements and regulatory filings (US, EU and Rest of World).
• Development and coordination of internal (Abbott) and external (Third Party Manufacturer in Germany) quarterly Quality Management System (QMS) Reviews to determine and demonstrate appropriateness, suitability and effectivity of the Quality Systems and deliverables.
• Management and support for corporate audits and Regulatory Authority Inspections including review of final reports, input and evaluation of responses and CAPA plans and follow-up on findings.
• Support and assistance with regulatory submissions including Biological Product Deviation Reports (BPDRs), Annual Product Reviews (APR) and Product Quality Reviews (PQR).
• Development and periodic evaluations of departmental SOPs.
• Management of two quality professionals including directing workflow, staffing responsibilities, performance reviews, growth plans, personnel development and department budget.

International Quality Assurance Compliance Program Manager

Confidential

Responsibilities:

• Planning and conducting internal audits and/or assessments to evaluate compliance of International manufacturing plants and distribution centers against polices, current Good Manufacturing Practices (cGMP), local requirements and applicable guidelines.
• Coordination of process/system improvement plans to address compliance concerns including recommendation for CAPA and prioritization to minimize or mitigate compliance risk (e.g., projects to promote personnel training, production processes improvements, and evaluation of new systems and contract services to support manufacturing requirements).
• Support international affiliates on quality and technical issues.
• Management and support of corporate audits and Regulatory Authority Inspections.
• Management of one quality professional including directing workflow, administrative staffing responsibilities, performance reviews, growth plans and personnel development.

Quality Assurance Cell Source Project Coordinator

Confidential

Responsibilities:

• Development, implementation and maintenance of Quality Systems to comply with industry standards for Good Tissue Practices (cGTP), cGMP and applicable guidelines, for two out-of-state Third Party Manufacturers (TPMs) providing the starting material for a biopharmaceutical product (i.e., thrombolytic).
• Management and support of TPM audits, corporate audits and Regulatory Authority Inspections.
• Training of TPM personnel on cGTP, cGMP and applicable guidelines, and Aseptic Manufacturing Operations personnel on Basic Microbiology and Applied Microbiology.

International Clinical Auditor

Confidential

Responsibilities:

• Organizing, leading, conducting and follow-up of internal and external GCP audits to assess compliance to Sponsor study protocols and SOPs, International Conference on Harmonization (ICH) Guidelines, applicable US Food and Drug Administration (FDA) regulations and local regulations.
• Internal audits: reviews of clinical trial study protocol, informed consent form (ICFs), trial master file (TMF), database audit, clinical study report (CSR) and clinical quality system audits.
• External audits: clinical investigator site, contract research organizations (CROs) and facility audit of Phase I units.
• GCP compliance presenter at external and internal training workshops (e.g., Investigator meetings, Clinical Research Associate CRA workshops, clinical project management and GCP auditor training).
• Periodic evaluation and revision of departmental SOPs, forms and templates.
• Management and support for corporate audits and Regulatory Authority Inspections.

Associate Scientist

Confidential

Responsibilities:

• Laboratory support for research projects targeted towards the discovery, characterization, and development of diagnostic assays for hepatotropic viruses.
• Development of immunoassays for the detection of antibodies to various microorganisms.

Confidential, Mundelein, IL

Laboratory Assistant

Responsibilities:

• Sterility and bioburden testing of hospital products.