Associate Director QA for Materials, Supply Chain and QC

Position Overview

The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released are tested in accordance with GMP regulations. Provides QA support for approval of specifications, documentation, reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote a robust Quality Culture within Quality function and for supporting functions. Proactively engage with the organization to drive continuous improvements within the team. As member of the site Quality leadership team contribute to cohesive execution of quality initiatives and projects throughout the site in Holly Springs.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drivewhat we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."

Job Description

What You'll Do

Manages QA for Materials, Supply Chain and QC team which includes release of materials, Supplier Quality program and support for QA for QC team. Supervision includes planning, goal setting and supervision of personnel in accordance with company goals. Provides QA oversight and support for QC and Supply Chain including Warehouse and ensure team is staffed with adequate resources and skillsets to support these areas. Collaborates with Global QA teams including Supplier Quality and external audit teams to implement and ensure adherence with global programs and needs. Ensures alignment with other QA functions in driving continuous improvements and Quality mindset activities across the site. Provides resources for Supplier Quality Function execution of external audits, supplier complaints, Quality agreements for suppliers, vendor / supplier changes to support both local and global needs for this area. Provides Quality oversight and approval of system and process lifecycle documentation, including risk and impact assessments for processes and equipment. This also includes QA approval of documentation, changes, deviations and CAPAs for the areas. Ensures strong collaboration with operational peer network and promote a strong Quality culture for the site. Generates, reviews and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility including trend reports for process for QC and Supply Chain activities. Ensures training needs for the team are met and complies with GMP guidelines for the QA function within area of responsibility. Ensures that project and operational quality objectives are met within desired timelines. Collaborates and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency. Develops and supports start up activities into operations as the project matures, such as system optimization or improvement initiatives and supporting regulatory agency and third-party inspections. Coaches and mentors' direct reports and team members to foster professional development and growth. Enforces and ensures team adheres to company policies and procedures. Participates in the recruitment process to attract talent. Collaborates with Human Resources (HR) and Talent Acquisition and provides input to develop retention strategies. Addresses employee concerns and partners with HR for resolution, as needed. Evaluates team performance and address gaps appropriately. Performs Other duties, as assigned

Minimum Requirements :

Bachelor's degree in Engineering, Life Sciences with 12+ years of related experience (e.g., Statistical Control of Manufacturing Processes or Development of Data Collection / Management Systems) OR MS degree in Engineering, Life Sciences with 10+ years of related experience (e.g., Statistical Control of Manufacturing Processes or Development of Data Collection / Management Systems) OR Ph.D. with 8+ years' experience 8+ years of people management and leadership experience Experience working in a GMP environment

Preferred Requirements :

Experience collaborating and interacting with a global team. Experience with multivariate data analysis

Physical and Work Environment Requirements :

Ability to discern audible cues.

Ability to inspect or perform a task with 20 / 20 corrected vision, visual acuity, including distinguishing color.

Ability to stand for prolonged periods of time up to 60 minutes.

Ability to sit for prolonged periods of time up to 60 minutes.

Ability to conduct activities using repetitive motions that include wrists, hands and / or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.

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.