Senior Executive Director, Quality Management System

🔥 5 minutes ago

🏄 California, Massachusetts, +1 more states – Remote

🏄 California – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

💵 $250k - $300k / year

⏰ Full Time

🟠 Senior

👔 Director

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Jade Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• 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 • Provide coaching as a manager and team member, make quality decisions and be Quality Approver as appropriate. • Act as the primary QMS subject matter expert and point of contact for all related matters and issues. • Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings. • Champion continuous improvement and simplification across quality systems. • Contribute to building a strong quality culture within the organization. • 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. • Provide leadership in inspection preparedness. • Apply risk‑based thinking to identify the quality activities that meaningfully influence outcomes. • Understand when to escalate, when to intervene, and when to let teams move forward. • Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

🎯 Requirements

• Bachelors + 17 or Masters + 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 product • 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. • Must have 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. • Ability 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).

🏖️ Benefits

• This is a remote role, however, 10-20% travel to team and company events is required.