Jade Biosciences
Biotechnology
Senior/ExecutiveDirector,QualityManagementSystem
“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
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