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.
Location: Woodlands, TX
Essential Duties and Responsibilities:
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Provide day-to-day leadership and oversight for QA Operations supporting GMP pDNA Manufacturing and QC, together with site Quality Systems.
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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.
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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.
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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.
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Provide appropriate Quality oversight and guidance for GMP activities while working collaboratively across functions to support compliant and effective execution.
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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.
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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.
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Ensure Manufacturing and QC readiness requirements are identified and resolved before execution, testing, or disposition activities become schedule-critical.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Partner with Process/Analytical Development and MSAT to ensure appropriate transfer of pDNA processes, analytical methods, specifications, controls, and supporting documentation into GMP Manufacturing and QC operations.
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Partner with Facilities/Engineering and Validation to support qualification and lifecycle management of facilities, utilities, manufacturing equipment, laboratory equipment, cleaning processes, computerized systems, and environmental controls as applicable.
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Provide Quality input during client onboarding, project planning, technology transfer, manufacturing readiness, analytical readiness, GMP campaign planning, and schedule development as required.
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Serve as the site Quality escalation point for Manufacturing and QC issues, driving timely resolution collaboratively with management or independently, as appropriate based on risk and criticality.
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Support development and execution of Quality Agreements and ensure client-specific Quality and release requirements are translated into site execution plans.
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Lead Quality Management Review inputs and ensure meaningful trends, recurring issues, systemic risks, and improvement opportunities are escalated and acted upon.
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Promote a culture in which Quality is integrated proactively into operations and program execution rather than functioning only as a final review or approval step.
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Build, coach, and develop a high-performing QA team capable of supporting a growing, multi-client pDNA CDMO operation.
Working Conditions:
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Requires regular presence in GMP microbial manufacturing and QC laboratory areas.
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May require standing, sitting, walking, gowning, and movement through controlled manufacturing and laboratory spaces.
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May require support outside normal business hours during critical manufacturing operations, testing, investigations, client activities, or inspections.
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Occasional travel up to 15% may be required for client engagement, audits, training, conferences, or vendor visits.
Qualifications:
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BS/MS in Biology, Microbiology, Biochemistry, Chemistry, Engineering, Pharmaceutical Sciences, or a related life science discipline; advanced degree preferred.
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5 to 10 years of progressive Quality experience in biopharmaceutical, biologics, plasmid DNA, microbial manufacturing, cell and gene therapy, vaccine, or related GMP environments, including meaningful leadership responsibility.
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Demonstrated experience leading or providing senior QA Operations oversight for both GMP Manufacturing and QC laboratory functions.
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Strong working knowledge of 21 CFR Parts 210/211, applicable ICH guidance, EU GMP expectations, data integrity principles, and pharmaceutical Quality Systems.
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Demonstrated experience with batch record review, disposition/release, deviations, CAPA, change control, OOS/OOT, specifications, investigations, validation/qualification, document control, and Quality risk management.
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Experience establishing, maintaining, and improving Quality Systems in a growing, changing, or start-up GMP manufacturing organization.
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Strong understanding of QC laboratory operations, analytical method lifecycle, method qualification/validation, specifications, reference standards, stability, data review, and laboratory investigations.
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Experience supporting manufacturing-floor QA and making timely, risk-based Quality decisions during GMP execution.
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CDMO experience strongly preferred, including experience supporting multiple client programs, Quality Agreements, competing priorities, and aggressive timelines.
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Strong risk management, root cause analysis, strategic thinking, troubleshooting, and continuous improvement capabilities.
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Excellent written and verbal communication skills, including the ability to translate complex Quality and regulatory issues into clear, actionable recommendations.
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Authorized to legally work in the United States without visa sponsorship.
The base compensation range for this role is $150,000-$164,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.
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