Associate Director, Quality Compliance

About Jade Biosciences

Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead candidate, JADE
101, is designed to inhibit the cytokine APRIL (A Proliferation‑Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN), a chronic kidney disease that can impair kidney function over time. JADE
101 aims to reduce harmful IgA antibodies, lower proteinuria (a key marker of kidney damage), and preserve long‑term kidney function. A Phase 1 healthy‑volunteer study of JADE
101 is ongoing, with interim, biomarker‑rich data expected in the first half of 2026. Jade’s pipeline also includes a second development candidate, JADE
201, and an undisclosed antibody discovery program, JADE‑003, both currently in preclinical development. For more information, visit  and follow us on Linked In.

The Associate Director, Quality Compliance will lead the development, implementation and management of external and internal GxP (GLP, GCP and GMP) audits. This key position is responsible for all aspects of the audit lifecycle from development of Jade’s risk‑based annual audit plan to monitoring and presentation of the performance and maturity of the audit program. In addition, this individual will support due diligence supplier assessments and continuous monitoring of supplier inspection performance.

The position reports to the Executive Director, Quality and Compliance.

• Implement and deliver a risk‑based and data‑driven strategic audit plan.
• Manage all aspects of the audit lifecycle including scheduling, planning, agenda issuance, audit execution, report issuance, response evaluation, request clarification, observation report creation, timely closure and tracking of supplier audit CAPA(s), and audit closure.
• Work directly with cross‑functional departments to gather key information and feedback prior to conducting supplier audits to ensure that the audit agenda is risk‑based and has the appropriate internal and/or external subject‑matter experts as part of the audit team.
• Communicate directly with suppliers to schedule audits, request required documentation prior to audit commencement, provide formal audit outcome, obtain responses and provide formal notice of audit closure.
• Ensure CAPA(s) address compliance concerns identified during audits are commensurate with observation classification, overall risk and current biologics industry practices.
• Provide oversight and direction to contractor auditors, including monitoring performance and adherence to established processes to drive consistency with audit report observation writing, classification, status and overall risk.
• Own the development, implementation and maintenance of systems, procedures and templates to assist in the monitoring, evaluation and improvement of the auditing process.
• Gather and report GxP audit performance measures and maturity at senior leadership meetings such as quarterly Management Review.

• 13+ years of relevant experience in the pharmaceutical industry; an advanced degree in a relevant field (e.g., Biotechnology, Biochemistry, Molecular Biology, Engineering) is preferred.
• Background in Biologics Operations (Manufacturing, Quality Control, Quality Assurance).
• Expert level experience in scheduling, planning, execution and follow‑up on audits.
• Excellent verbal, written and interpersonal skills.
• Thorough knowledge of compliance requirements, and an understanding of current global and regional trends in compliance.
• Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205, 210, 211, 600, 610, 820;
  Eudra Lex Volume 4 and applicable annexes; and Health Canada R.S.C., 1985, F‑27, Section 30; as well as ICH, ISO, PIC/S and USP/NF, EP, and JP compendial standards and principals as applicable.
• Experience in leading investigations, root cause analysis and CAPA implementation preferred.
• Excellent analytical, problem‑solving and decision‑making skills preferred.
• Strong leadership and project management abilities preferred.

This is a fully remote role with up to 20%…