VP of Quality Compliance

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

Bionova became a subsidiary of Asahi Kasei Medical, a division of Tokyo-based Asahi Kasei Group, in 2022. 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.

Position Summary:
Bionova Scientific is seeking a Vice President of Quality Compliance to oversee all quality areas, including Quality Assurance, Quality Control, and Quality Systems. This individual will be a key player in the Company's success and will be responsible for managing client audits and other efforts with a proactive approach. The Company is looking for an exceptional candidate who can demonstrate strong leadership skills in the management of Quality Compliance. The ideal candidate should possess prior experience in the field of monoclonal antibodies and E. coli to effectively oversee and drive the quality compliance agenda.

Primary Responsibilities:

• Ensure the success of the of Bionova Scientific’s Quality Compliance through strategic and tactical leadership.
• Lead the quality organization in the continuous improvement of the quality management plan and serve as the final decision maker for all quality decisions including release of commercial or investigational product for market or clinical distribution, respectively.
• Execute on all aspects of the Quality Management System including but not limited to Audit planning and Execution, Deviations, CAPAs, Change Controls, Good Documentation Practice, cGMP System Validation, Inspection Readiness, Issue Management, Process Development, Risk Management and Training
• Demonstrated success in evaluating quality compliance issues in all phases of commercial readiness, followed by a recommendation for effectively resolving the business challenge.
• The VP of Quality will be responsible for QA aspects of vendor oversight including audits, establishment of Quality Agreements, major deviation review, and batch disposition/release.
• Oversee the planning and conduct of internal and external audits to ensure compliance with regulatory requirements for clinical trials and for investigational drug manufacturing, and ensure corrective actions are implemented to resolve audit findings.
• With the Quality organization and through existing Quality Systems and processes, lead all aspects of required quality support to various product development projects and support progression from Clinical to Commercial (readiness) Programs throughout their lifecycles.
• Establish and maintain a robust compliance audit program that ensures compliance of external and internal functions in the execution of cGMP responsibilities.
• Respo