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) to support initial licensure and sustainable operations.
• Identify, assess, and mitigate quality and compliance risks through structured risk assessments, readiness reviews, and escalation mechanisms. Ensure timely resolution of gaps impacting startup or regulatory commitments.
• Define readiness metrics, dashboards, and governance routines to track progress and ensure accountability. 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.