GMP Manufacturing Operations Leader

Position Overview

Step into a leadership role where your guidance, operational rigor, and people-first approach will drive reliable, compliant production. As Manager, Manufacturing Support, you'll build and lead a talented team, oversee critical manufacturing support activities, and partner cross-functionally to ensure operational readiness, continuous improvement, and inspection readiness across a dynamic, cGMP environment.

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:

Job Description

About Us

We are a collaborative, growth-focused manufacturing organization committed to quality, safety, and operational excellence. Our teams work at the intersection of science and execution, enabling consistent, compliant production in a highly regulated setting. We value inclusivity, accountability, and continuous improvement-and we support our leaders with the tools, autonomy, and trust to make a meaningful impact.

Responsibilities

During the project phase:

• Provide oversight and lead operational readiness projects, including but not limited to:
• Lead the creation or transfer (from an existing large-scale facility) of manufacturing support team business processes to ensure GMP operational readiness
• Lead, manage, and build the manufacturing support team
• Administer company policies that directly impact employees
• Complete required administrative tasks (e.g., time card approvals, time off approvals, expense reports)
• Perform other duties, as assigned

• Manage, lead, and develop direct reports within the manufacturing support team while overseeing, organizing, and coordinating team tasks
• Foster an inclusive, people-first culture by creating meaningful development plans with direct reports and conducting regular 1:1s and skip-level 1:1s
• Provide oversight and coordinate non-batch activities and collaborate cross-functionally, including:
• Ownership of manufacturing change controls and corrective and preventive actions (CAPAs)
• Short flow investigations and management of alert/action limits
• Detailed batch manufacturing schedules
• Campaign materials readiness and coordination
• Ensure continuous improvement; drive escalation and mitigation of manufacturing issues
• Manufacturing training and curricula management
• Act as functional lead for regulatory inspections and audits
• Administer company policies that directly impact employees
• Complete required administrative tasks (e.g., time card approvals, time off approvals, expense reports)
• Perform other duties, as assigned

• High School diploma or GED with 10 years related experience OR
• Bachelor's Degree with 6 years related experience OR
• Master's Degree with 4 years of related experience
• 4+ years of experience managing, leading, and developing people
• Experience with regulatory inspections, investigations and change management
• Experience directly supporting manufacturing

• 6-10 years' experience in manufacturing operations
• Previous experience leading others in a manufacturing facility
• Experience working in a changing, project-driven organization
• Lean certification or similar certifications

• Experience with regulatory inspections, investigations and change management preferred
• Experience in pharmaceutical / biological manufacturing operations preferred
• Experience leading others in a pharmaceutical/biological manufacturing facility preferred

• Ability to collaborate with manufacturing and other functional areas
• Strong…