Associate Director – Quality Assurance - Operational Readiness

About the role

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. This role provides end-to-end quality leadership to ensure that facilities, utilities, equipment, systems, processes, and teams are inspection-ready, compliant, and capable of sustained GMP execution at startup and beyond.

Responsibilities

• Define and drive the site Quality Operational Readiness strategy to ensure GMP compliance, inspection readiness, and successful regulatory approval.
• Ensure quality requirements are embedded into design, qualification, validation, and startup activities.
• Partner with Project Management, Engineering, Operations, TSMS, Regulatory, and Global Quality to align quality readiness activities with project milestones and startup timelines.
• Act as the primary quality interface for site readiness governance.
• Partner with other stakeholders within and outside the quality team to establish and execute the site Quality Management Systems (e.g., deviations, change control, document management, training).
• Identify, assess, and mitigate quality and compliance risks through structured risk assessments, readiness reviews, and escalation mechanisms.
• Drive disciplined execution of quality deliverables across all startup phases.
• Support building and developing the site Quality organization through effective staffing, training, coaching, and knowledge transfer.
• Foster a strong “Safety First & Quality Always” mindset from project phase through commercial operations.

Requirements

• Bachelor’s degree in a scientific, engineering, or related discipline.
• 8+ years of experience in Quality within regulated GMP environments (Pharma, Biotech, or Medical Devices).
• Demonstrated experience supporting site startups, major expansions, or large capital projects from a Quality perspective.
• Strong working knowledge of GMP regulations, inspection readiness, validation, and quality systems.

Additional Preferences

• Prior experience in greenfield or brownfield manufacturing startups.
• Experience working with regulatory submissions, approvals, and pre-approval inspections.
• Strong understanding of aseptic manufacturing, utilities, equipment qualification, and data integrity principles (preferred for parenteral facilities).
• Proven ability to lead through ambiguity, manage competing priorities, and make risk-based quality decisions under time pressure.
• Excellent communication and stakeholder management skills, with the ability to influence across functions and levels.
• Collaborative leadership style with the ability to balance compliance, speed, and business needs.