The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
Company:
Bionova Scientific LLC
Job Description:
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 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, root cause analysis, strategic thinking, troubleshooting, and continuous improvement capabilities.
- Excellent written and verbal communication skills, including the ability to translate complex Quality and regulatory issues into clear, actionable recommendations.
- Experience with electronic Quality Management Systems; MasterControl, VEEVA or comparable systems preferred.
- 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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