Sr. Director of Quality Assurance

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:

Company Summary:

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, agilityand an interest in transformative action are also common attributes among our team.

Position Summary
The Sr. Director of Quality Assurance will provide leadership and oversight of end to end operations and systems activities, including client facing interaction, batch disposition activities, inspection readiness, amongst others. The also acts as the Management Representative for the Bionova Scientific Quality Management System (QMS).

Duties and Responsibilities

• Lead the Quality Assurance organization to generate a strong quality culture of engaged and motivated staff maintaining strong working relationships with clients, internal and external customers: Quality Control, Manufacturing, Engineering, supply chain and Process Development.
• Implement and maintain a compliant QMS that is fit for purpose (clinical vs commercial) and follows and improves business performance and efficiency. Including measurement of the effectiveness of the QMS highlighting areas of risk/improvement to Site Leadership governance structure (e.g. Management Review).
• Participate as subject matter expert in deviation management investigations, CAPA and effectiveness check processes for continuous improvement and inspection readiness. Overall responsibility for quality systems performance and health of the QMS.
• Establish and manage the Inspection Readiness program, Supplier Qualification program and overall Supplier lifecycle program.
• Overall responsibility for the Batch Disposition program ensuring compliance with relevant regulations.
• Manage relationship with clients’ QA organization.
• Define and maintain a strong people management, training, and engagement culture to ensure a high and constantly improving right first time rate in manufacturing and QC.
• Identify, recruit and manage the QA team, implementing a strong quality culture and ensuring staff engagement and development in line with the site competency framework. Own the succession plan for the team ensuring business continuity and staff retention/engagement.
• Act as deputy for the SVP Quality and Compliance.
• Perform other duties as assigned commensurate with job grade.

Working Conditions:

• This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching.  The employee must occasionally lift and or move up to 20 pounds independently.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline with 15+ years of relevant experience, or combination of experience and relevant advanced degree.
• In-depth understanding of technical documentation and knowledge of regulations: 21 CFR, ANNEX 1, ICH Q, etc.
• Experienc