Associate Director, Compliance at Jade Biosciences

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Jan, 26

Salary

185000.0

Posted On

25 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Compliance, Auditing, Risk Management, Quality Assurance, Quality Control, Biologics Operations, Regulatory Knowledge, Investigation, Root Cause Analysis, CAPA Implementation, Project Management, Analytical Skills, Problem-Solving, Interpersonal Skills, Communication Skills, Leadership

Industry

Biotechnology Research

Description

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, JADE101, 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. JADE101 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 JADE101 is ongoing, with interim, biomarker-rich data expected in the first half of 2026. Jade’s pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both currently in preclinical development. For more information, visit JadeBiosciences.com and follow us on LinkedIn. Role Overview The Associate Director, 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. This position will report to the Executive Director, Quality and Compliance. Key Responsibilities 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 supplier to schedule audit, request required documentation prior to audit commencement, provide formal audit outcome, obtain response(s) 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. Conduct due diligence assessments as part of global expansion as required. Continuously monitor inspection performance of current suppliers. Provides support for domestic and foreign regulatory agency site inspections, as needed. Support investigation teams on quality issues/events investigations, as appropriate. Support other quality functions based on qualifications and resource needs. Required Qualifications and Experience: Bachelors degree with 13+ years of related experience or Masters with 10+ years of related experience 10+ 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; EudraLex 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% domestic and/or international travel as a key position requirement. Position Location This is a remote role; periodic travel to team and company events is required. The anticipated salary range for candidates for this role is $170,000 - $185,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Responsibilities

The Associate Director, Compliance will lead the development, implementation, and management of GxP audits. This role involves managing the entire audit lifecycle and ensuring compliance with industry standards.