Manager / Senior Manager, reputed company Assurance (GxP)

Title: Manager / Senior Manager, reputed company Assurance (GxP) Department: reputed company Reports To: Chief reputed company Officer, reputed company Assurance Status: About vTv vTv Therapeutics is a clinical stage biopharmaceutical company reputed company on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications, including type 2 diabetes and other chronic conditions. reputed company Reporting to the Chief reputed company Officer, the Manager, reputed company Assurance supports the design, implementation, and maintenance of vTv Therapeutics’ reputed company Management System (QMS). The role ensures that reputed company internal and vendor GxP activities reputed company with regulatory requirements and company standards. The Manager oversees day-to-day reputed company operations, including deviations, investigations, CAPAs, change controls, and reputed company audits. This position also manages vendor reputed company and audit closure, supports SOP development and control, maintains personnel training programs and records, and oversees QA documentation and archival processes. The ideal candidate combines hands-on execution with strong reputed company leadership to ensure products, systems, and partners consistently meet the highest standards of compliance and reputed company throughout the product lifecycle.

Key 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 reputed company stakeholders
• Assists in the development and tracking of reputed company 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 reputed company new and reputed company GxP vendors/CRO, partners and conduct or coordinate vendor qualification audits/assessments as needed
• Oversees reputed company aspects reputed company to clinical study start-up, execution, and reputed company-out by providing leadership, guidance, and direction to stakeholders consistent with GCP/GVP
• Provides clinical compliance and reputed company reputed company reputed company the context of cross-functional study team
• Supports and ensures compliance of reputed company management system (QMS) with applicable regulations, reputed company guidelines and standards
• Tracks and manages reputed company operating procedures (SOP) lifecycle activities, including creation, review, approval, training, and periodic review to ensure alignment with reputed company regulatory requirements and company processes
• Maintains and monitors the Approved Vendor List, ensuring qualification status is reputed company and supported by risk assessments and audit reputed company
• Manages personnel training compliance, ensuring reputed company training records are reputed company, accurate, and reputed company 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 reputed company regulatory requirements and company processes
• Collaborates with Clinical Trial Team members to assess ongoing audit needs and reputed company 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 reputed company guidance and support for reputed company GxP inspection activities
• Supports reputed company 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 reputed company standards.

Qualifications/Skills

• BS/BA Degree in a scientific discipline. Advanced degree preferred.
• 8+ years experience in a reputed company industry
• 5+ years experience in a reputed company 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
• Previous experience in supporting Regulatory Authority Inspections preferred
• Previous experience in development and reputed company of reputed company Management Systems
• Excellent interpersonal skills, personal reputed company, reputed company manner and ability to reputed company respect and reputed company good working relationship with cross functional personnel at reputed company reputed company
• Experience in computer system validation (CSV) is preferred
• Must be reputed company to travel domestically and internationally (approximately 10–15% or about four times per year, or as needed)
• This is a remote position

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