Director / Senior Director, Quality Assurance (GMP)

Title: Director / Senior Director, Quality Assurance (GMP)Department: QualityReports To: Chief Quality Officer, Quality AssuranceStatus: Full- TimeAbout VTvvTv 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.DescriptionReporting to the Chief Quality Officer, Quality Assurance, the Senior Director will provide strategic GMP direction and quality oversight for to the chemical, controls and manufacturing (CMC) teams for overall product technical development. The role will be responsible for GMP batch record review, disposition and change management for API, drug product and finished goods and general quality oversight and quality control of the contract development manufacturing organization (CDMO) process and delivery for the lifecycle drug process development. The Sr. Director is responsible for developing, implementing, and overseeing a cGMP comprehensive Quality Assurance (QA) strategy to ensure the highest standards of compliance across all applicable manufacturing, packaging, and analytical testing across all aspects of drug development. In addition, the Sr. Director will perform GMP vendor audits and internal audits to ensure compliance with regulatory requirements, internal procedures, and industry standards. This role will serve as the primary Quality leader for the CMC team, ensuring that products, processes, and systems meet regulatory requirements, corporate objectives, and industry best practices.Key ResponsibilitiesEnsures cGMP analytical activities, such as analytical methods, release testing results and method validation, and Certificates of Analysis (CoA), comply with internal SOPs, company policies and procedures, and safety, environmental and regulatory requirementsDevelops and reviews with the CMC team and CDMOs: drug substances (DSs), drug products (DPs), key raw material and intermediates, specifications and stability requirements, master batch records, validated manufacturing processes and analytical methods, clinical trial materials (CTMs) and commercial packaging and labelingReviews cGMP batch manufacturing and packaging records and provides recommendations for approval/rejection and dispositionReviews and approves annual drug stability program with foresight for requirements for post market requirements for designated batches per regulatory and commercial viability Manages and approves cGMP investigations, quality issues, deviations, CAPAs, change control and out-of-specifications/out-of-trends (OOS/OOTs), including adequate and compliant investigations; follows up to verify effectivenessPartner with CMC and Regulatory Affairs on development projects, method and process transfer/optimization and validation program requirementsAssists with development and implementation of cGMP compliant systems, including internal SOPs, forms, and work instructionsLeads the GMP gap assessment and corrective actions in preparation for new drug application (NDA) filingPerforms independent audits for compliance to policies and proceduresAssists with preparation of internal quality audit programs and conducts internal audits per approved schedules in accordance with pertinent quality documents; prepares all corresponding documents and reports;Leads all external GMP audits of domestic and international vendors, including conducting GMP vendor audits outside the US, as needed;Coordinates annual and ongoing cGMP training;Acts as a primary contact for GMP regulatory inspections;Qualifications/SkillsBachelor's degree in Science or related field; advanced degree preferredAt least 12 years of experience in the pharmaceutical or biotechnology industry, with significant expertise in Quality or a related functionMinimum of 8 years of Quality leadership/management experience in director or higher-level positionMust have strong knowledge of GMP and US FDA regulatory requirements with emphasis on compliance and experience in regulatory submissions, with hands-on experience implementing and managing Quality systems Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic environmentProven ability to foster cross-functional collaboration and build relationships at all organizational levelsSuperior team leadership, communication, collaboration, and problem-solving skillsExperience in all phases of regulatory submissions and interactions; international experience desiredExperience with documentation systems and with document review and auditingExtensive experience handling health authority inspectionsSmall molecule drug development experience highly desirableExperience in overseeing or participating in GMP audits and building team for batch review and releaseAdvanced knowledge of Quality Assurance principles, concepts, industry practices, and standardsMust be able to travel occasionally, approximately 10–15% annually (equivalent to about four trips per year). 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