VP of Quality Compliance

Job Description

Bionova is a rapidly growing CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our success is built on top scientific talent, the best available tools, and an agile culture focused on solving difficult client problems.

Bionova became a subsidiary of Asahi Kasei Medical in 2022, accelerating growth of the business and expanding into new service offerings.

Bionova Scientific seeks a Vice President of Quality Compliance to oversee all quality areas, including Quality Assurance, Quality Control, and Quality Systems. The VP will manage client audits, lead quality initiatives, and drive the quality compliance agenda for monoclonal antibodies and

E. coli processes.

• Lead strategic and tactical quality leadership to ensure Bionova Scientific’s quality compliance success.
• Serve as final decision maker for all quality decisions, including release of commercial or investigational products.
• Execute all aspects of the Quality Management System: audit planning, deviations, CAPAs, change controls, GDDP, cGMP validation, inspection readiness, issue management, process development, risk management, and training.
• Evaluate quality compliance issues in all phases of commercial readiness and recommend effective resolution.
• Oversee QA vendor oversight: audits, quality agreements, major deviation review, batch disposition/release.
• Plan and conduct internal and external audits to ensure compliance with regulatory requirements for clinical trials and investigational drug manufacturing, implementing corrective actions to resolve audit findings.
• Lead quality support for product development projects and support progression from Clinical to Commercial readiness programs throughout their life cycles.
• Establish and maintain a robust compliance audit program for cGMP responsibilities.
• Lead all quality activities for internal operations, contract manufacturers, contract laboratories, cGMP service providers, consultants, and partners.
• Ensure sufficient staffing, education, and development of quality teams, and manage all personnel aspects of the quality organization.
• Create a positive, safe work environment that engages team members and supports healthy work life balance.
• Represent Quality in executive interactions, internally and externally with partners, Health Authorities, and corporate matters.
• Integrate risk management into compliance and quality.
• Develop and execute a comprehensive budget for quality operations both day-to-day and during company expansion.
• Work closely with process development colleagues to establish appropriate analytical support for accelerated process decisions.
• Execute continuous improvement opportunities for QC laboratory to drive operational efficiencies.
• Establish clear expectations, metrics, and KPIs to monitor business process performance and stability.
• Provide leadership, coaching, and guidance to the team.
• Build strong relationships with key cross‑functional stakeholders:
  Clinical Operations, Data Management, CMC, Regulatory, and Project Management.
• Oversee the EH&S function.
• Offer expert advice on quality compliance matters while assisting in the expansion into Viral Vector and PDNA domains.

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

• Advanced degree in Pharmaceutics, Biochemistry, Physical Chemistry, Organic Chemistry, Biochemical Engineering, or related experience.
• 20+ years of experience leading and managing large teams in Quality Compliance, QA, and Quality Systems.
• Prior experience with monoclonal antibodies and
  
  E. coli is required.
• Superb quality decision making, sound leadership judgment, and proven communication capabilities in the biopharmaceutical industry for large‑molecule products.
• Complete understanding of the commercialization and commercial requirements of a CDMO, biologics‑based process, and products in the U.S.
• Excellent oral and written communication skills, ability to communicate at executive team…