Senior/Executive Director, Quality Management System

About the role

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL and is currently in a Phase 1 clinical trial for immunoglobulin A nephropathy. Jade’s pipeline includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, and JADE301, an undisclosed antibody candidate, both in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics.

Responsibilities

• Select, implement, manage, and oversee GxP electronic systems including any associated Purchase Orders and contracts.
• Develop, implement, manage, continuously improve, and oversee processes such as Document Management, Training Management, Change Control, Management Review (MR), Annual Product Quality Review (APQR), Deviation/CAPA/Risk Management, and GxP Computer System Assurance.
• Guide and support GxP process owners with implementation and improvement /optimization of key functional area processes.
• Establish and improve policies and standard operating procedures for efficient and compliant management of GxP QMS processes.
• Establish, track and report quality metrics for QMS processes and present improvement opportunities at Management Review meetings.
• Implement phase appropriate, risk-based, fit-for-purpose approaches to QMS processes.
• Ensure that QMS processes comply with phase applicable regulatory standards, regulations and guidelines.
• Maintain awareness of new regulations, technologies, industry trends and best practices and apply them as may be relevant.
• Manage resources to achieve company, department and functional area goals and objectives.
• Contribute to the development and maintenance of a positive team-focused company culture.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, CMC and other departments to drive inspection readiness and support regulatory interactions.
• Prepare KPIs, metrics and analysis and present status updates as needed.
• Apply risk-based thinking to identify the quality activities that meaningfully influence outcomes.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Qualifications

• Bachelor's + 17 or Master's + 14 or PhD + 10 years of related experience within the pharmaceutical industry.
• Minimum of eight (8) years building, implementing and/or managing Quality Management Systems within the pharmaceutical industry.
• At least five (5) years of experience with Phase 3 and/or commercial products.
• At least three (3) years of experience in an outsourced environment.
• Successful track record of translation and implementation of requirements into operational execution.
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations (e.g. EU, China, Japan, Australia) and practices.
• Excellent verbal, written, interpersonal, organizational and communication skills both internally and externally.
• Strong technical understanding and experience in implementing and validating cloud-based (hosted) computer systems.
• The ability to perform at executive levels while collaborating with key stakeholders in an exciting, dynamic environment with a high degree of engagement and enthusiasm.
• Ability to make timely and sound quality decisions when faced with complex compliance, technical and regulatory considerations.
• Highly skilled in the ability to work with ambiguity and complexity.
• Ability to work with minimal supervision, to set priorities to meet timelines, and to manage, motivate and influence others with variable workloads and demanding timelines.
• Prior management experience is required.
• Able to tactically and strategically execute the day-to-day operations to support Jade’s goals.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs) from scratch.
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Proficiency in using SharePoint, Veeva and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).