Manager, 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:

This role presents a unique opportunity to establish the foundation and set direction for the facility currently being designed and constructed. The role will be responsible for leading Quality Assurance activities, staffing the functional area, and ensuring compliance of site manufacturing processes according to cGMP regulations. Also responsible for implementing, maintaining, and monitoring all Quality processes necessary for that assurance. This includes running the operations according to cGMP regulations, and identifying and implementing business process improvements and that will drive site's business performance and Quality innovation.

The QA Manager also provides technical expertise on Quality Assurance standards and processes to team members; and provides input on QA strategy.

Essential Duties and Responsibilities:

• Establishing QA operations and ensuring alignment with regulatory expectations and industry standards.
• Write, review, and/or approve SOPs, Quality Standards, etc.
• Participate as subject matter expert in deviation management investigations, CAPA and effectiveness check processes for continuous improvement and inspection readiness.
• Performs review and approval for CAPAs, commitments, change requests, investigative protocols, and final reports.
• Ensures compliance with Data Integrity principles and alignment with internal procedures and regulatory requirements.
• Provide quality oversight of commissioning and qualifications related to computerized system, utilities and/or software associated with GMP equipment to ensure compliance and adherence with BNS procedures, cGMP, and ISPE GAMP guidelines and regulations.
• Review and approve validation related system lifecycle documents (URS, F/DS, qualification protocols/reports, plans, trace matrices, etc.).
• Review and approve engineering, facilities, and quality documentation as applicable.
• Provide quality oversight of QC activities, review and approve test records, specifications, test methods etc.
• Prepares for, manages and coordinates regulatory and client audits including leading inspection/audit readiness efforts as a part of cross-functional & multi-departmental team.
• Collaborates with clients and other departments (Facilities & Engineering, Technical Operations, Clinical Operations, Quality Control, and IT).
• Provides coaching and guidance to new personnel and to Quality Specialists who are training new personnel.
• Facilitate a continuous improvement culture with other departments.
• Keep abreast of industry trends, emerging technologies, and best practices in Plasmid DNA testing to ensure the company remains competitive and innovative.
• Perform other duties as assigned.

Working Conditions:

• This position requires to work in a mfg/lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 10 pounds independently.
• Initially, remote working conditions transitioning to long term permanent, onsite position; occasional travel.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related discipline with 5+ years of relevant experience, or combination of experience and relevant advanced degree.
• Flexible mindset for a dynamic environment.
• Ability to communicate clearly and professionally in writing and verbally.
• Strong analytical and problem-solving skills
• Strong knowledge of cGMP standards, validation principles, Quality Systems, manufacturing, and facility equipment/systems
• Strong independent judgment and decision-making abilities and strong conflict resolution required.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint.
• Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.

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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