Director / Senior Director, Quality Assurance (GMP)

Title :

• Director / Senior Director, Quality Assurance (GMP) Department : Quality Reports To : Chief Quality Officer, Quality Assurance Status : Full- Time 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, 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 Responsibilities   Ensures 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 requirements Develops and reviews with the CMC team and CDMOs :