Senior/Executive Director, Quality Management System

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
• 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, Chi

Benefits

Additional Information

About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade's lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade's pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn . Role Overview The Senior/Executive Director, Quality Management System (QMS) will be responsible for driving and delivering the activities necessary to develop, implement, and continuously improve a phase appropriate GxP QMS. This role will be directly involved with both strategy development and day-to-day tactical execution related to QMS 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. The Sr./Exec. Director will be responsible for the maintenance of both paper-based and electronic processes and lead quality initiatives to support the pace and growth of the organization. This role will maintain and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with all applicable quality requirements and regulatory standards. The ideal candidate brings hands-on expertise in creating and maintaining a GxP QMS, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of quality and compliance.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at jadebiosciences? Share your experience