Associate Director, Quality Assurance
Bionova Scientific LLC

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. As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals who are dedicated to advancing the field of Plasmid DNA process development and manufacturing. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and empowering them in an agile, energized culture focused on solving difficult client challenges.

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.

Position Summary:

The Associate Director of Quality Assurance will provide leadership and QA oversight of end-to- end operations and systems activities at the Bionova Scientific Plasmid DNA facility in Houston, TX. Key activities include oversight of GMP facility readiness, client facing interaction, oversight of manufacturing and QC operations, amongst others.

Essential Duties and Responsibilities:

• Implement overall quality strategy for facility expansions and readiness projects and ensure it is aligned with the Site's expansion strategy
• Act as the Lead Quality Assurance SME in relation to facility GMP readiness and overall oversight of operations at Houston
• Collaborate with Corporate Quality organization to ensure alignment in the quality plan and implementation of the quality management system at the Houston site
• Participate as subject matter expert in deviation management investigations, CAPA and effectiveness checks
• Responsible for QA approvals of validation, QC and manufacturing records
• 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 the first-time rate in Bionova operations
• Identify, recruit and manage the QA team under his/her area of responsibility, 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.
• Identify and implement QA improvement projects for Plasmid DNA and Viral Vector assets, following corporate quality systems and regulatory requirements (e.g., US FDA and European)
• Perform other duties as assigned commensurate with job grade.

Working Conditions:

• This position requires 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 5 pounds independently

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related discipline with 10+ years of relevant experience, or combination of experience and relevant advanced degree.
• In-depth understanding of technical documentation and knowledge of regulations: ISO, 21 CFR, ANNEX 1, ICH Q, etc.
• Experience leading and participating in regulatory inspections, client audits, etc.
• Flexible mindset for a dynamic environment.
• Strong project management capabilities.
• Ability to independently evaluate technical situations and propose potential solutions.
• Ability to communicate clearly and professionally in writing and verbally
• Flexibility with work hours to meet business needs.
• Strong analytical and problem-solving skills

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

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