Jade Biosciences
Biotechnology
Senior/ExecutiveDirector,QualityManagementSystem
Neural analysis suggests this role is
optimal for Director candidates.
“Senior/Executive Director, Quality Management System at Jade Biosciences. Skills: Quality Management System, GxP QMS, Regulatory compliance. Drive GxP QMS development. Implement GxP QMS”
Industry & Context.
Problem-solving; Risk-based thinking
10-20% travel
What They're Looking For.
Must Have
Bachelors + 17 years experience, Masters + 14 years experience, PhD + 10 years experience, 8 years building QMS, 5 years Phase 3 experience, 5 years commercial product experience, 3 years outsourced environment experience, Extensive FDA regulations knowledge, Extensive ICH guidance knowledge, Knowledge of global regulations, Prior management experience required, Proficiency in SharePoint, Proficiency in Veeva, Proficiency in MS Outlook, Proficiency in MS Word, Proficiency in MS Excel, Proficiency in MS PowerPoint
Nice to Have
Experience with commercial product, Experience in an outsourced environment, Experience implementing cloud-based systems, Experience validating cloud-based systems
What You'll Do.
Drive GxP QMS development
Oversee GxP electronic systems
Manage GxP electronic systems
Develop GxP processes
Implement GxP processes
Improve GxP processes
Oversee GxP processes
Guide GxP process owners
Support GxP process owners
Track quality metrics
Report quality metrics
Present improvement opportunities
Implement risk-based approaches
Ensure QMS process compliance
Maintain awareness of regulations
Apply new regulations
Achieve company goals
Achieve department goals
Achieve functional area goals
Contribute to team culture
Make quality decisions
Act as Quality Approver
Review service agreements
Approve service agreements
Review qualification forms
Approve qualification forms
Review onboarding forms
Approve onboarding forms
Review regulatory filings
Approve regulatory filings
Champion continuous improvement
Champion simplification
Build quality culture
Direct yearly training
Deliver yearly training
Drive inspection readiness
Support regulatory interactions
Present status updates
Apply risk-based thinking
Identify quality activities
Intervene when needed
Let teams move forward
Keep teams inspection ready
Translate requirements
Implement requirements
How You'll Work.
Team & Collaboration
Cross-functional teams; Key stakeholders; Development department; Clinical Operations; CMC department
Communication Scope
Verbal skills; Written skills; Interpersonal skills; Organizational skills
Process & Methodology
GxP, Risk Management
Full Job Description
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. Key Responsibilities Select, implement, manage, and overse
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