Jason Smyth

About Jason Smyth

Quality Assurance leader with extensive experience in the pharmaceutical, biotechnology and medical device industries. Twenty-five years experience in commercial and clinical manufacturing. Successfully managed quality system development and implementation.Experience:Provide strategic and operational leadership for all GXP activities for oncology company with a focus on developing a sustainable Culture of Quality. Positioned the organization to support Development activities while building for Commercial readiness and launch. Development and implementation of Quality Management System to support Commercialization.QA management of clinical manufacturing operations for qualification/validation, deviations, CAPAs, change control, product release, clinical lot release for US and European trials.Managed QA operations with multiple CMOs (drug product, API, testing labs, suppliers)Internal and external auditor (suppliers, CMOs) Extensive experience resolving discrepancies and developing CAPAs in commercial and clinical manufacturing operations.Expertise in validation, change control, risk management, manufacturing requirements, environmental monitoring, and project managementCorporate responsibility for DEA regulation compliance and management for global controlled substance programsSpecialties: Quality Leadership and StrategyChange control, document control Deviations, OOS, CAPAValidation (process, facility, equipment, cleaning, master plan)Auditing, supplier qualityTrend analysisQuality metricsTrainingAPI and Drug Product releaseLabel approvalLine ClearanceApprovals: SOP’s, master batch records, specifications, validation reports, GLP reports, Clinical Study Reports, COAMaterial Review BoardChange Control Review BoardInspection ReadinessIND, IMPD, NDA preparation/review

Experience

1. Vice President of Quality

   Vera Therapeutics, Inc.

   Jan 2025 — Present

   Head of the Quality organization responsible for all aspects of GxP Compliance including GCP, GMP, and GLP. Provide leadership to quality staff and provide strategic direction for the Quality function. Collaborate with senior leaders across the organization to ensure business objectives are met while building an appropriate Quality approach to ensure alignment with regulations and industry best practices across Vera’s programs.

Skills

• Pharmaceutical Industry
• Sop
• Fda
• Technology Transfer
• U.s. Food and Drug Administration (Fda)
• V&V
• Quality Control
• Gmp
• Biotechnology
• Computer System Validation
• Manufacturing
• Validation
• Change Control
• Quality Assurance
• Medical Devices
• Capa
• 21 Cfr Part 11
• Verification and Validation (V&V)
• Change Management
• U.s. Title 21 Cfr Part 11 Regulation
• Corrective and Preventive Action (Capa)
• Pharmaceutics
• Sdlc
• Standard Operating Procedure (Sop)