VP of Quality Compliance

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.
• Responsible for leadership of all Quality activities for internal operations as well as for contract manufacturers, contract laboratories, cGMP service providers, consultants, and partners.
• Lead the quality organization in the execution of the quality management plan, ensuring sufficient and appropriate staffing of key and required functions, continued education and development of quality teams, and all aspects of personnel management.
• Create and sustain a positive, safe, and appropriate work environment that engages team members and allows them to sustain a healthy work life balance.
• Serve as final decision maker for all product quality or compliance decisions, including release of materials, intermediates, drug substance and drug products.
• Represent Quality in all executive level interactions, internally and externally with partners, Health Authorities, or in corporate matters.
• Ensure the integration of risk management in compliance and quality.
• Responsible for developing and executing a comprehensive budget for quality operations, both day-to-day and during the company's expansion.
• Work closely with process Development colleagues in establishing appropriate analytical support for dynamic, accelerated process decisions.
• Define and execute on continuous improvement opportunities for QC laboratory to drive efficiencies in operations.
• Establish clear expectations, metrics and KPIs, to monitor business process performance and stability.
• Provide leadership, coaching and guidance to the team.
• Be an effective communicator of ideas, project goals and results to team members across the development and commercial organization.
• Implement and integrate risk management into the quality management of clinical and commercial products.
• Build strong relationships with key cross-functional stakeholders including Clinical Operations and Data Management, CMC (technical operations, supply chain, analytical development), Regulatory and Project Management
• Oversee the EH&S function.
• Offer expert advice on Quality compliance matters while assisting in the expansion of the company's reach into the Viral Vector and PDNA domains.

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.

Required Skills:

• Advanced degree in Pharmaceutics, Biochemistry, Physical Chemistry, Organic Chemistry, Biochemical Engineering, or related experience.
• 20+ years of experience leading and managing large teams in a combination of Quality Compliance, Quality Assurance and Quality system is required.
• Prior experience with monoclonal antibodies and E. coli is required.
• Superb quality decision making skills, sound leadership judgment, and proven communication capabilities, as well as significant experience in the biopharmaceutical industry specifically large molecule, are critical factors for success.
• Complete understanding of the commercialization and commercial requirements of a CDMO, Biologics based process and products in the US.
• Excellent oral and written communication skills, ability to communicate at executive team levels, and proven ability to work autonomously and manage effectively in a matrix environment.
• Articulate, persuasive and demonstrated ability to influence others, while employing sound judgment and good sense
• Possesses the strongest ethics and integrity.
• Experience with analytical method validation and optimization for drug substance/drug product release and stability testing is required.
• Experience with applying the principles and techniques of analytical chemistry is required
• Extensive experience and knowledge of GMPs is required.

Compensation Range: The base compensation range for this role is between $243,000 and $260,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.