Associate Director - QA

About the role

The Associate Director of Quality Assurance will lead QA operations for Bionova Scientific's pDNA manufacturing site in The Woodlands, Texas. This senior position provides site‑level quality leadership for GMP pDNA production, QC laboratory activities, and the overall Quality System.

Key responsibilities

• Provide day‑to‑day leadership for QA supporting GMP pDNA manufacturing and QC.
• Oversee site Quality Systems, ensuring compliance with cGMP and internal standards.
• Lead client, corporate, and regulatory audits/inspections, manage observations to closure.
• Partner with Manufacturing, MSAT, Facilities, Supply Chain, and Program Management to enable compliant, on‑time program execution.
• Identify quality risks early, communicate them clearly, and develop risk‑based mitigation plans.
• Maintain inspection readiness and integrate quality requirements into technology transfer and product disposition.

Required profile

• Extensive experience in cGMP, microbial/biologics manufacturing, and laboratory quality.
• Proven track record leading QA teams in a CDMO environment.
• Strong ability to work cross‑functionally and build trust with manufacturing and engineering groups.
• Excellent communication skills for risk reporting and audit coordination.

Required skills

• cGMP
• GMP
• pDNA manufacturing
• QC laboratory operations
• Quality Systems management