Associate Director - QA

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.

Bionova Scientific LLC

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.

• 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…