Sr. Director, Quality

COMPANY INTRODUCTION Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine.  We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect. SUMMARY   Triveni is in search of an experienced Sr. Director, Quality, to lead Triveni’s Quality function, ensuring compliance and excellence in our clinical and manufacturing operations. Reporting directly to the CEO, you will play a pivotal role in shaping and executing our quality strategy, while owning and evolving our Quality Management System (QMS).  On a day-to-day basis, you will oversee quality operations, guide internal teams and external partners, manage audits and inspections, and collaborate cross-functionally to ensure regulatory compliance and continuous improvement. You must have extensive experience in GMP compliance and a strong understanding of GCP principles, ideally within a biotech environment. This role requires a strategic leader who can operate across disciplines and drive quality excellence in early development. As part of a lean and agile team, you’ll have the opportunity to shape quality systems that support Triveni’s mission.  RESPONSIBILITIES   Lead and manage Triveni’s Quality organization, including GxP Quality Systems, Quality Assurance (GMP, GCP, GLP), and Quality Control oversight.  Define the overall Quality vision and strategy that is tailored to Triveni’s size, stage of development, and business needs.  Serve as primary contact for internal teams and CROs/vendors on GMP, GCP, and GLP matters.  Ensure compliance with FDA, EMA, ICH, and other applicable regulatory requirements.  Maintain a phase appropriate Quality Management System (QMS), including SOPs, training, document control and vendor oversight.  Serve as the company’s quality authority in support of regulatory inspections/submissions and partner audits.  Provide quality oversight of Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and Contract Testing Laboratories (CTLs).  Ensure robust vendor qualification, quality agreements, and performance management systems are in place.  Develop and report quality metrics to executive leadership.  Partner cross-functionally with members from Regulatory Affairs, Manufacturing, Clinical Operations, Supply Chain, and Nonclinical to ensure seamless integration of quality processes throughout the product life cycle in alignment with GxP requirements.  Other duties as assigned.   EXPERIENCE & QUALIFICATIONS Bachelor’s degree in a scientific or engineering discipline  12+ years of experience in Quality roles within the biotech industry.  Deep understanding of global GxP regulations (FDA, EMA, ICH) and quality expectations for biologics and/or advanced therapies.  Proven leadership experience in building and scaling quality systems and teams.  Experience managing QMS platforms and regulatory inspections.