Manager / Senior Manager, Quality Assurance (GxP)

Title :

• Manager / Senior Manager, Quality Assurance (GxP) Department : Quality Reports To : Chief Quality Officer, Quality Assurance Status : About vTv vTv Therapeutics is a clinical stage biopharmaceutical company focused 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.
• Description Reporting to the Chief Quality Officer, the Manager, Quality Assurance supports the design, implementation, and maintenance of vTv Therapeutics’ Quality Management System (QMS).
• The role ensures that all internal and vendor GxP activities comply with regulatory requirements and company standards.
• The Manager oversees day-to-day quality operations, including deviations, investigations, CAPAs, change controls, and internal and external audits.
• This position also manages vendor oversight 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 quality leadership to ensure products, systems, and partners consistently meet the highest standards of compliance and quality 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 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.
• Qualifications / Skills   BS / BA Degree in a scientific discipline.
• Advanced degree preferred. 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 Previous experience in supporting Regulatory Authority Inspections preferred Previous experience in development and oversight of Quality Management Systems Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels Experience in computer system validation (CSV) is preferred Must be able to travel domestically and internationally (approximately 10–15% or about four times per year, or as needed) This is a remote position   Powered by JazzHR