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vTv Therapeutics · 3 weeks ago

Manager / Senior Manager, Quality Assurance (GxP)

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

vTv Therapeutics is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. The Manager/Senior Manager, Quality Assurance is responsible for supporting the design, implementation, and maintenance of the Quality Management System, ensuring compliance with regulatory requirements and overseeing day-to-day quality operations.

BiotechnologyHealth CareInnovation ManagementPharmaceutical

Responsibilities

Plans, prepares and conducts GCP/GLP/GVP audits of clinical investigators, nonclinical and clinical vendors and systems and follows up on any findings/observations, including corrective actions and preventative actions (CAPAs), and communicates results to internal and external stakeholders

Assists in the development and tracking of internal and external GxP annual audit plans for sites and vendors and update the audit plan as needed based on identified risks and trial priorities

Participates in the risk assessment of all new and current GxP vendors/CRO, partners and conduct or coordinate vendor qualification audits/assessments as needed

Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to stakeholders consistent with GCP/GVP

Provides clinical compliance and quality oversight within the context of cross-functional study team

Supports and ensures compliance of quality management system (QMS) with applicable regulations, quality guidelines and standards

Tracks and manages standard operating procedures (SOP) lifecycle activities, including creation, review, approval, training, and periodic review to ensure alignment with current regulatory requirements and company processes

Maintains and monitors the Approved Vendor List, ensuring qualification status is current and supported by risk assessments and audit outcomes

Manages personnel training compliance, ensuring all training records are current, accurate, and aligned with role-specific requirements and applicable SOPs

Oversees document management and control processes, including filing, archival and retrieval of QA documentation

Assists in the development and maintenance of GxP audit management processes and documentation including policies, SOPs, and guidelines

Tracks and manages SOP lifecycle activities, including creation, review, approval, training, and periodic review to ensure alignment with current regulatory requirements and company processes

Collaborates with Clinical Trial Team members to assess ongoing audit needs and provide GxP guidance to functional teams, and execute directed audits, where required

Participates in inspection readiness and preparedness activities (i.e., sponsor, monitor, sites, etc.) and provide guidance and support for all GxP inspection activities

Supports internal and external audits, regulatory inspections, and Inspection Readiness activities

Coordinates and manages QA Consultants and contract auditors, as appropriate, ensuring deliverables are completed according to timelines and quality standards

Qualification

Quality AssuranceGxP ComplianceAudit ManagementSOP DevelopmentRegulatory InspectionsClinical Trial SupportRisk AssessmentPersonal IntegrityProfessional MannerComputer System ValidationInterpersonal Skills

Required

BS/BA Degree in a scientific discipline

8+ years experience in a related industry

5+ years experience in a Quality Assurance role, GLP/GCP/GVP, including both external and internal audits

Experience working with and providing GCP advice to clinical trial teams

Experience in drafting and reviewing SOPs

Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels

Must be able to travel domestically and internationally (approximately 10–15% or about four times per year, or as needed)