Associate Director - QA

Associate Director Of QA

The Associate Director of QA is a driven, resourceful, and solution-oriented leader for Bionova Scientific's pDNA site in The Woodlands, Texas. This position will provide site-level Quality leadership and oversight for GMP pDNA manufacturing, QC laboratory operations, and the site's Quality Systems.

The ideal candidate will bring strong cGMP, microbial/biologics manufacturing, laboratory Quality, and Quality Systems experience together with a practical CDMO mindset. This leader will partner closely with Manufacturing, QC, MSAT, Facilities/Engineering, Supply Chain, and Program Management to enable compliant, predictable, and timely execution of pDNA client and internal programs.

The role requires proactive identification of Quality and release-critical dependencies, clear and timely risk communication, consistent application of regulatory and internal requirements, and the ability to develop compliant, risk-based paths forward. Success will depend on maintaining inspection readiness, strengthening the site's Quality Systems, building cross-functional trust, and integrating Quality requirements early into program planning, technology transfer, manufacturing, testing, and disposition.

Essential Duties and Responsibilities:

• Provide day-to-day leadership and oversight for QA Operations supporting GMP pDNA Manufacturing and QC, together with site Quality Systems.
• Demonstrated experience leading and hosting client, corporate, and regulatory audits/inspections including preparation, front-room/back-room coordination, response development, and management of audit observations through closure.
• Maintain regular and transparent communication with the Site Head through scheduled 1:1s, leadership meetings, presentations, and periodic Quality updates, providing clear visibility to Quality System health, compliance risks, audit/inspection readiness, Manufacturing and QC issues, release-critical dependencies, and emerging concerns.
• Develop and present concise, data-driven Quality updates and presentations for Site Leadership as needed. Escalate urgent or high-impact Quality risks promptly to ensure timely awareness and cross-functional action.
• Provide appropriate Quality oversight and guidance for GMP activities while working collaboratively across functions to support compliant and effective execution.
• Provide QA presence and support on the manufacturing floor, including real-time assessment of GMP events, documentation practices, deviations, line clearance, material status, and adherence to approved procedures and batch records.
• Provide QA oversight of QC laboratory operations supporting pDNA, including sample management, specifications, analytical method qualification/validation, data review, laboratory investigations, OOS/OOT events, reference standards, stability, and release testing.
• Ensure Manufacturing and QC readiness requirements are identified and resolved before execution, testing, or disposition activities become schedule-critical.
• Ensure release-critical Quality requirements and cross-functional interdependencies are identified early, assessed for risk and criticality, assigned clear ownership, and communicated through project and site governance.
• Review and approve, as applicable, specifications, master and executed batch records, SOPs, protocols, reports, deviations, CAPAs, change controls/MOCs, investigations, method qualification/validation documentation, facility/equipment qualification documentation, and other GMP records.
• Support disposition and release activities for raw materials, master/working cell banks, intermediates, pDNA drug substance/product, reference standards, and other applicable GMP materials in accordance with approved specifications, procedures, and Quality Agreements.
• Lead and continuously improve site Quality Systems, including document control, deviations, CAPA, change control, training, risk management, supplier quality, audit management, and Quality Management Review.
• Lead the evaluation of data integrity practices and drive the assessment and implementation of digital Quality and laboratory systems, including LIMS and/or new or enhanced electronic QMS platforms. Ensure Quality requirements are applied consistently and that regulatory requirements, internal Quality System/procedural requirements, client requirements, and risk-based Quality decisions are clearly understood, documented, and communicated.
• Drive timely investigation and closure of deviations, CAPAs, change controls, OOS/OOT events, and other Quality records using scientifically sound root cause analysis and effective corrective and preventive actions.
• Partner with PM, Manufacturing and QC leadership to establish and monitor Quality KPIs that provide early visibility to compliance, investigation, testing, release, and execution risks.
• Partner with Process/Analytical Development and MSAT to ensure appropriate transfer of pDNA processes, analytical methods, specifications, controls, and supporting documentation…