Associate Manager, QC Raw Materials

The Associate Manager leads a subsection of the Global QC Raw Material group, ensuring that day-to-day tasks are carried out efficiently in relation to raw material activities for tech transfers and material lifecycle management. This involves coordinating the team’s workload, developing team members through targeted training and performance evaluations, and driving projects and cross-site collaboration. The function also includes tracking team progress, promoting innovation, and ensuring alignment with departmental milestones, as well as global QC milestones. Through effective communication, resource management, and strategic oversight, the Associate Manager fosters overall quality, compliance, and continuous improvement within the organization.

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 drive—what 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

• Coordinates day-to-day activities, scheduling and resource allocation, balancing the QC Raw materials team’s workload against established priorities and management milestones (e.g., report/data approval, schedules, quality systems).
• Implements best industry practices, identifies areas for improvement, and continuously seeks to enhance operational quality and efficiency in close collaboration with the remainder of the Global QC Raw Material leadership team.
• Authors and reviews procedures, documents, and reports to support QC Raw Materials operations and tech transfer activities; routes for approval per quality systems.
• Maintains GMP-compliant operations by adhering to procedures, global directives, and quality systems; ensures inspection readiness and complete, accurate documentation.
• Represents the team both within and outside the organization, facilitating clear communication and fostering collaborative relationships.
• Optimizes team performance by systematically tracking workload, successes, and challenges, and by recommending improvements to support overall departmental efficiency.
• Supports tech transfer projects by coordinating materials readiness, data collection, and actively engaging in customer communications.
• Collaborates cross-functionally with QC Analytical Development, QC Program Management, Manufacturing, Process Science, Supply chain and Quality Assurance to meet program deliverables.
• Execute first-line people leadership tasks per company policies, including on-the-job coaching, feedback, and day-to-day guidance of team members.
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees.
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.).
• Performs other duties as assigned.
  
  

Knowledge, Kills, Or Abilities

• Displays and advanced knowledge of regulatory requirements for materials (e.g., cGMPs, USP, EP, JP, and ICH)
• Possesses a broad knowledge of quality control operations, systems, and directives.
• Ability to challenge and interpret regulations with scientific confidence and sound risk-based judgement.
• Demonstrates excellent leadership and people management skills.
• Demonstrates excellent technical writing skills, and clear oral and written presentation abilities.
• Ability to make clear and informed decisions with limited information based on previous experience with analytical transfers.
• Strong stakeholder management and communication skills, enabling alignment across sites and global functions.
• Displays strong organizational skills with an ability to multi-task and coordinate multiple activities in parallel.
• Able to work effectively, independently and within a team framework, across all business areas and levels of the organization.
• Ability to coach, lead, and develop individual contributors.
  
  

Minimum Qualifications

• Bachelor’s degree in Life Sciences or Engineering and 6 years of experience in GMP quality assurance and/or similar role OR,
• Master’s degree in Life Sciences or Engineering and 4 years of experience in GMP quality assurance and/or similar role.
• 5 years of experience within pharmaceutical industry, preferably within the field of starting materials.
• Prior leadership experience.
  
  

Preferred Qualifications

• 2 years of direct supervisory experience.
• 5 years of experience in a GMP environment.
• Experience with Microsoft Office, Smartsheet, LIMS and ERP systems (e.g., SAP).
  
  

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in hearing conservation program.
• Ability to stand for prolonged periods up to 60 minutes.
• Ability to sit for prolonged periods up to 30 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
  
  

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.

• LI -Onsite
  
  

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).