Kailera Therapeutics, Inc.
Biotech/Pharmaceutical
SeniorDirector,QualitySystems
“Senior Director, Quality Systems at Kailera Therapeutics, Inc.. Skills: Quality Systems, GxP regulations, Veeva QualityVault, Regulatory inspections. Define and execute the long-term vision for the Quality Management System (QMS). Provide Quality oversight for GxP systems change controls”
Industry & Context.
pragmatic problem-solving
What They're Looking For.
Must Have
12+ years of experience in Quality Assurance within the Biotech/Pharmaceutical industry, at least 5 years in a senior leadership capacity, Direct experience implementing or managing Veeva QualityVault is mandatory, Proficient in configuring workflows and leveraging the platform for data-driven decision-making, Proven track record in mid-sized companies navigating the transition from early-phase clinical trials to late-stage pivotal studies, Deep knowledge of global GxP regulations, experience participating in (or leading) successful regulatory inspections, Exceptional ability to translate complex quality requirements into actionable business strategies for non-quality stakeholders, Bachelor’s degree required, scientific or engineering discipline preferred
Nice to Have
Advanced degree preferred
What You'll Do.
Define and execute the long-term vision for the Quality Management System (QMS)
Provide Quality oversight for GxP systems change controls
Support validation planning
Act as the Business Owner for Veeva QualityVault
Lead the optimization of modules including Document Control
Establish and lead Quality Management Reviews (QMR)
Develop and report on Key Quality Indicators (KQIs) and metrics
Ensure the QMS meets global regulatory requirements
Lead the QMS strategy for inspection readiness
Serve as a key interface during regulatory inspections
Oversee the internal and vendor audit programs
Champion a culture of Quality
Streamline complex workflows to reduce cycle times
Build and mentor a high-performing team of Quality professionals
How You'll Work.
Team & Collaboration
fostering a collaborative environment; balancing technical rigor with pragmatic problem-solving; translating complex quality requirements into actionable business strategies for non-quality stakeholders
Communication Scope
translate complex quality requirements into actionable business strategies for non-quality stakeholders
Process & Methodology
validation planning, validation execution, validation approvals, change controls, deviation closures
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