The Associate Director – Quality Assurance - Operational Readiness is a key site quality leader responsible for ensuring quality readiness of the Houston site as it transitions from project phase to GMP operations
Job Summary
The Associate Director – Quality Assurance - Operational Readiness is a key site quality leader responsible for ensuring quality readiness of the Houston site as it transitions from project phase to GMP operations.
The role partners closely with Project, Engineering, Operations, TSMS, Regulatory, and Global Quality to embed quality into design, qualification, operational readiness, and execution.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
Matching Summary
The Associate Director – Quality Assurance - Operational Readiness is a key site quality leader responsible for ensuring quality readiness of the Houston site as it transitions from project phase to GMP operations.
Salary
Base: $123,000 - $180,400; Bonus/Equity: company bonus; Benefits: comprehensive benefit program
Skills & Requirements
Must-have
Quality Operational Readiness strategy
GMP compliance and inspection readiness
Quality Management Systems establishment
Risk identification and mitigation
Execution readiness and performance monitoring
Cross-functional alignment and partnership
Nice-to-have
Collaborative leadership style
Strong communication and stakeholder management
Ability to lead through ambiguity
Foster a strong mindset
Key Requirements
Bachelor's degree in scientific or engineering discipline
8+ years in Quality within regulated GMP environments
Experience supporting site startups or major projects
Strong knowledge of GMP regulations
Experience with regulatory submissions and inspections