Connie Smith

About Connie Smith

Information Technology/Quality professional with extensive experience in the pharmaceutical and CRO industry, specifically Business Relationship Management, IT Quality, and Computer System Validation. Detail oriented, strategic thinker who excels at delivering business critical solutions that meet regulatory requirements, on time and on budget. Proven leader responsible for company compliance with FDA and Sarbanes-Oxley (SOX) regulations. Areas of expertise include: • Business Relationship Management• Business Process Improvement• Customer Engagement• SDLC Methodologies (Waterfall/Agile)• Project Management (PMP® certified)• Computer System Validation (CSV)• End to End System Implementations• IT Compliance (GAMP5, 21 CFR Part 11)• Vendor Management/Vendor Qualification• IT Audit

Experience

1. Directory, IT Quality & Compliance

   Crinetics Pharmaceuticals

   Oct 2023 — Present

   Develop and maintain the IT Quality Management System (QMS) by review existing SOPs and prepare new procedures required to serve as the framework for Computer System Validation Projects. Support all aspects of IT Quality & Compliance including SOX, privacy, auditing, etc. – both in development and execution of processes.Develop, validate, and maintain computerized system applications and processes in compliance with GxP regulatory guidelines and expectations. Develop and support all IT Quality processes, including SOX reporting, privacy compliance (GDPR, CCPA, etc.), vendor audits, and any other aspect of IT Compliance. Participate in corporate committees that set strategy for compliance in order to provide the IT perspective and lead the development of IT processes to support initiatives. Support data integrity activities for computer systems and assume responsibility for the implementation, administration and process improvements needed to meet business and domestic / international compliance requirements. Strong ability and experience in the development of processes and the auditing of vendors that provide SaaS and PaaS.Conduct external / internal audits associated with computer systems for privacy, GxP and other compliance frameworks, and develops overall audit process for IT in conjunction with the corporate quality and compliance functions.Ensure compliance of computerized systems to relevant regulatory requirements (e.g, GxP/GAMP). Assist in the development of a validation remediation strategy.Support of electronic system applications (QualityDocs, QMS, Training Vault, etc.) through validation, maintenance, quality administration, training, and process improvement initiatives and activities.

Education

• East Carolina University

  Bachelor of Science (B.S.), Biology/Biological Sciences, General

  1987 — 1991

• East Carolina University

  Bachelor of Science (B.S.), Biology, General

  1987 — 1991

Skills

• Process Improvement
• Management
• Team Building
• Clinical Trials
• Customer Engagement
• Quality System
• Regulatory Compliance
• U.s. Title 21 Cfr Part 11 Regulation
• U.s. Food and Drug Administration (Fda)
• Gmp
• Quality Assurance
• Customer Support
• Standard Operating Procedure (Sop)
• Corrective and Preventive Action (Capa)
• Software Implementation
• CRO
• Six Sigma
• Gxp
• Validation
• Vendor Audit
• IT Strategy
• Change Control
• Biotechnology
• IT Audit
• Business Analysis
• Software Development Life Cycle (Sdlc)
• Leadership
• Clinical Trial Management System (Ctms)
• Software Documentation
• Sdlc
• Ctms
• Pharmaceutics
• Life Sciences
• Vendor Management
• Cross-Functional Team Leadership
• Computer System Validation
• Gamp
• Medical Devices
• Capa
• Relationship Management