Associate Director - QA

About the role

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 provides site-level Quality leadership and oversight for GMP pDNA manufacturing, QC laboratory operations, and the site's Quality Systems. The ideal candidate brings strong cGMP, microbial/biologics manufacturing, laboratory Quality, and Quality Systems experience together with a practical CDMO mindset. This leader partners 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.

Responsibilities

• Provide day-to-day leadership and oversight for QA Operations supporting GMP pDNA Manufacturing and QC, together with site Quality Systems
• Lead and host 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 into GMP Manufacturing and QC operations
• 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
• Provide Quality input during client onboarding, project planning, technology transfer, manufacturing readiness, analytical readiness, GMP campaign planning, and schedule development as required
• Anticipate potential compliance or execution roadblocks, communicate them proactively, and bring forward viable compliant paths with clear scientific and risk-based rationale
• 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
• Support development and execution of Quality Agreements and ensure client-specific Quality and release requirements are translated into site execution plans
• Lead Quality Management Review inputs and ensure meaningful trends, recurring issues, systemic risks, and improvement opportunities are escalated and acted upon
• 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
• Build, coach, and develop a high-performing QA team capable of supporting a growing, multi-client pDNA CDMO operation
• Develop staffing, capability, training, and succession plans for QA Operations and Quality Systems as the pDNA business grows
• Champion continuous improvement, digitalization, and efficient use of the electronic Quality Management System while maintaining data integrity and compliance
• Support additional site, Quality, and business initiatives as needed, including special projects, cross-functional activities, and other responsibilities aligned with the needs of the pDNA site and assigned by the Site Head or senior leadership
• Collaborate closely with the Site Head and enterprise Quality/Regulatory leadership to ensure site practices remain aligned with Bionova and Asahi Kasei Quality expectations

Expectations from the role

• Solution-oriented: Brings compliant, practical paths forward rather than only identifying problems
• Proactive: Identifies Quality and release-critical dependencies before they impact manufacturing, QC testing, disposition, client commitments, or timelines
• Transparent and communicative: Maintains open communication with Site Leadership, ensuring appropriate visibility to Quality risks, priorities, decisions, and emerging issues, with timely escalation when urgent action or alignment is required
• Independent and collaborative: Protects independent Quality authority while working constructively with site leadership and cross-functional teams
• Consistent in judgment: Applies regulations, Quality System requirements, client commitments, procedures, and risk-based decisions consistently and transparently
• Clear in ownership: Understands QA authority and accountability while recognizing the broader impact of Quality decisions on the pDNA site and client programs
• Strong communicator: Raises concerns early, clearly explains the regulatory/scientific basis and risk, and supports timely alignment and escalation
• CDMO-minded: Understands that compliance, product quality, client commitments, execution predictability, responsiveness, and speed must be managed together

Working conditions

• This position is primarily on-site at the Bionova Scientific pDNA facility in The Woodlands, Texas
• Requires regular presence in GMP microbial manufacturing and QC laboratory areas
• May require standing, sitting, walking, gowning, and movement through controlled manufacturing and laboratory spaces
• May require support outside normal business hours during critical manufacturing operations, testing, investigations, client activities, or inspections
• Occasional travel up to 15% may be required for client engagement, audits, training, conferences, or vendor visits

Qualifications

• BS/MS in Biology, Microbiology, Biochemistry, Chemistry, Engineering, Pharmaceutical Sciences, or a related life science discipline; advanced degree preferred
• 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
• Demonstrated experience leading or providing senior QA Operations oversight for both GMP Manufacturing and QC laboratory functions
• Strong working knowledge of 21 CFR Parts 210/211, applicable ICH guidance, EU GMP expectations, data integrity principles, and pharmaceutical Quality Systems
• Demonstrated experience with batch record review, disposition/release, deviations, CAPA, change control, OOS/OOT, specifications, investigations, validation/qualification, document control, and Quality risk management
• Experience establishing, maintaining, and improving Quality Systems in a growing, changing, or start-up GMP manufacturing organization
• Strong understanding of QC laboratory operations, analytical method lifecycle, method qualification/validation, specifications, reference standards, stability, data review, and laboratory investigations
• Experience supporting manufacturing-floor QA and making timely, risk-based Quality decisions during GMP execution
• Experience with microbial fermentation and downstream purification is strongly preferred; direct plasmid DNA manufacturing experience is highly desirable
• CDMO experience strongly preferred, including experience supporting multiple client programs, Quality Agreements, competing priorities, and aggressive timelines
• Strong risk management and decision-making skills with the ability to balance compliance, product quality, and business needs