Director, Quality Systems - Fujifilm

Position Overview

The Director, Quality Systems and Support oversees and leads the QA Systems and Support function within FDBN. This includes, but is not limited to, managing team, ensuring the accuracy and timeliness of departmental deliverables, and upholding company core values. This role is also responsible for hosting and executing Quality site audits and regulatory inspections. Additionally, it supports QA Digital Technologies teams, Pharmaceutical Quality Systems, Application and Records Management, and Operational GMP Learning. This role ensures adherence to corporate policies and procedures for key quality subsystems (e.g., Business Process Owners for Change Management and Data Integrity) while maintaining quality systems in compliance with CGMP standards and regulatory requirements. All operations are conducted in accordance with executed training curricula and under appropriate quality systems such as ICH Q7, 21 CFR Part 820 and Part 11, EU GMP Volume 4, and enforcement of applicable FUJIFILM Diosynth Biotechnologies policies. This role fosters a strong Quality Culture across teams and contributes to cohesive implementation of quality systems at the Holly Springs site, aligning with organizational goals and regulatory expectations.

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

What You'll Do

• Develops strategic plans for Quality Systems and support team, sets measurable goals, and oversees the supervision, development, and performance of team to foster a high-performing team environment.• Oversees the maintenance and continuous improvement of pharmaceutical quality systems (PQS) to ensure compliance with current GMP, GDP, and regulatory requirements.• Ensures adherence for Pharmaceutical Quality system through effective implementation of global policies while meeting local operational needs. • Provides local ownership for systems supporting GxP Learning management, Documentation management as well as deviation and GxP change management system.• Leads the Quality Operational Learning team to ensure compliance and an effective training program for the site. • Leads the Quality Digital Technology team incl. providing Quality oversight for IT and automation and related systems by test and approval of computer system validation documentation. • Serves as a key stakeholder in business development efforts, sets and implements high standards for site through Data Integrity business process owner and contributing to the site's digital roadmap for GxP process data management.• Ensures the development, implementation, and maintenance of a compliant GxP Learning program.• Assures all departmental operations are conducted in accordance with executed training curricula and under appropriate quality systems.• Ensures timely availability of site quality performance data, including metrics for quarterly management reviews and to identify trends and drive improvements.• Monitors performance against agreed targets, driving accountability for achieving quality objectives.• Oversees the preparation, execution, and follow-up on commitments related to audits and regulatory authority health inspections.• Ensures audit findings are addressed effectively with corrective actions implemented to prevent recurrence for both local and global commitments related to the site.• Identifies opportunities for process optimization within Quality Systems to enhance efficiency while maintaining compliance.• Leads initiatives to improve quality processes, ensuring alignment with industry best practices and regulatory expectations.• Collaborates with internal stakeholders across functions to ensure seamless integration of Quality Systems into broader operational goals.• Represents the site in global forums to align local practices with global strategies and share best practices.• Actively participates in educating functions in applying a strong Quality mindset and ensures cGMP training of the site.• Partners with internal stakeholders and clients to support Quality initiatives and innovation projects.• Drives team’s efforts in curating critical knowledge to drive and developing best practices in Quality and Operational disciplines.• Mentors and motivates employees and oversees their development to ensure the team is positioned for long-term growth and success.• Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies.• Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities.• Performs other duties as assigned.

Minimum Requirements:

• Bachelor’s degree in engineering, life sciences with 15+ years of related experience OR• Master’s degree with 12+ years of related experience• 5-7 years of previous management or supervisory experience• Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility.• Working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines.• Experience from similar role in existing or startup facility. • Prior experience collaborating and interacting with a global team.• Experience in validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies

•  Quality Risk Management principles

Preferred Requirements:

• Experience working in a Good Manufacturing Practices (GMP) environment. • A minimum of 10+ years’ experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility • Experience from other GMP functions (manufacturing, MSAT, Engineering) • Strong track record of driving operational excellence. • Experience with the following processes such as, TrackWise, Veeva, SAP, Syncade.

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).