Vice President, Quality Assurance

The Vice President (VP) of Quality Assurance (QA) is a senior leader overseeing QA functions at our Holly Springs site. This pivotal role ensures compliance with regulatory standards, drives quality initiatives, and safeguards product and process integrity. Responsibilities include strategic planning, team leadership, and cross-department collaboration to promote quality excellence.

You will develop and implement the QA strategy for Holly Springs, working closely with the site Head and global leaders to ensure consistency. A key aspect of this role is overseeing the integration and adherence to the FDB quality system, ensuring robust operational standards. This position is also accountable for delivering quality programs and projects, ensuring staff engagement, and aligning execution with customer expectations, regulatory standards, and industry best practices.

As Vice President of QA, you are also a key member of the leadership team in Global QA Operations, playing an integral role in guiding global quality strategies. A significant responsibility includes participating in the development of the global QA strategy to enhance innovative, cross-corporate streamlined quality processes. This role will have approximately 5-10 direct reports and approximately 15-30 indirect reports.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

Main Responsibilities:

• Strategic Quality Assurance Leadership: Develop and drive the overarching quality assurance strategy to ensure alignment with corporate goals and regulatory requirements, enhancing operational standards at the Holly Springs site.
• Proactive Quality Management Culture: Establish and promote a culture of proactive quality management where QA principles are embedded across all functions and levels of the organization at the Holly Springs site.
• Regulatory Compliance Oversight: Ensure enterprise-wide compliance with global regulatory standards (e.g., FDA, EMA, ISO) and maintain readiness for upcoming regulatory inspections.
• Governance Frameworks Development: Develop and enforce governance frameworks for quality assurance policies, procedures, and best practices within the site.
• Quality Management System (QMS) Implementation: Lead the design, implementation, and continuous improvement of robust Quality Management Systems to ensure operational excellence and adherence to the FDB quality system.
• Performance and Compliance Monitoring: Monitor and establish Key Performance Indicators (KPIs) for QA system effectiveness while regularly updating executive leadership on performance, strategic progress, and compliance.
• Cross-Department Collaboration: Partner with executive leaders in R&D, manufacturing, supply chain, and additional departments to integrate quality assurance into all stages of the product lifecycle. Foster strong relationships with the Senior Leadership Team (SLT) to ensure alignment of quality initiatives with overall business objectives and strategic goals.
• Advisory Role in Quality Risks and Strategies: Serve as a key advisor to senior leaders on matters of quality risks, opportunities, and strategic initiatives, playing an integral role in guiding global quality strategies.
• Risk Management Development: Develop and implement risk-based approaches to identify, assess, and mitigate quality risks throughout the organization.
• Continuous Improvement Advocacy: Champion continuous improvement initiatives using data analytics to enhance product quality and operational efficiency.
• Site QA Team Leadership: Build and mentor a high-performing QA team at the Holly Springs site to meet current and future organizational needs, ensuring effective implementation of learning and development programs and conducting thorough supplier audits.
• QA Innovation and Compliance: Act as a change agent to promote innovation in QA practices while ensuring compliance with regulatory standards.
• Client and Regulatory Agency Engagement: Lead organizational readiness for client visits, audits, and regulatory inspections, ensuring alignment with compliance strategies and maintaining strong stakeholder relationships.
• Budget and Timeline Management: Govern enterprise budgets, timelines, and performance objectives to ensure consistent achievement of key deliverables and strategic alignment with organizational goals.
• Additional Responsibilities: Perform other duties as assigned to meet organizational objectives.
  
  

Minimum Education and Experience Requirements:

• Bachelor’s degree in engineering, life science or related field with 15 years of experience OR
• Master’s in a related discipline with 13 years of experience OR
• PhD in Science with 10 years of experience
• At least 10 years of leadership/management experience
• Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy with an understanding of control strategy.
• Previous experience in transition from construction site to fully operational site.
• Experience leading client site visits, audits, and regulatory inspections.
• Prior experience managing in a matrix organization and collaborating at a global level
• Strong strategic leadership capabilities with experience driving enterprise-wide quality initiatives.
• Expertise in quality management systems (QMS), risk management principles, and continuous improvement methodologies.
• Comprehensive understanding of regulatory requirements (e.g., FDA regulations, cGMPs, ISO standards).
  
  

Preferred Education and Experience:

• Experience working in a global environment with multi-site responsibilities.
  
  

Knowledge, Skills and Abilities:

• Strong orientation for quality, compliance, business ethics and customer service
• Strong leadership, collaboration, team building, program management and organizational skills
• Proven ability to develop, communicate, and execute plans and strategies with a wide range of stakeholders.
• High level of integrity and a drive for continuous improvement
• Strong collaboration and team building skills.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution.
• Excellent interpersonal, organizational, and written and oral communication skills
• Mastery knowledge of document management and lifecycle, and quality systems and their interconnections
• Mastery of GMP, regulations, and inspection/audit readiness
  
  

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).