Associate Director, QC Biological

Position Overview

The Associate Director, QC Biological is responsible for management of multiple labs within the Quality Control department including QC Microbiology. The individuals will act as a representative of QC in cross functional meeting focusing on both startup activities and routine operations. The leader will be responsible for hiring plans, budget development, strategic planning, and driving results. This role plans, schedules, and oversees multiple QC laboratories in order to drive compliance goals, schedule adherence, profit plans, and strategy objectives of the company and the department. The Associate Director, QC Biological identifies operational needs for special projects (new product sub-team, capital projects, etc.)- ensuring site/divisional linkage is achieved. This role identifies and addresses short term, intermediate, and long-term issues in a satisfactory manner, and appropriately resolves conflict and prioritizes work as necessary. The Associate Director, QC Biological will be required to manage through levels including managers, supervisors, individual contributors, etc.

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

What You'll Do

• Translates company goals into relevant department objectives, focused on assuring the compliance, supply, profit plan, strategy and people/culture objectives are appropriately implemented
• Provides logistical and strategic support for achieving department objectives
• Represents department for manufacturing, customer, and COE related activities as they relate to resource management
• Assures laboratory is capable of delivering to proposed or scoped customer requirements
• Assures adherence to headcount and budget plans
• Initiates and drives implementation of technology and projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality/safety enhancement. Fosters an environment for continuous improvement
• Maintains state of inspectional readiness for department
• Assures appropriate training requirements are established and that the staff maintains currency to the curricula
• Assures team delivers on-time results with right first-time quality
• Makes decisions on equipment selection, qualification, maintenance
• Assures transferred methods align with department analytical platforms
• Provides training and assurance that the transferred methods are fit for purpose and QC personnel are trained to perform the methods consistently
• Assures Quality System requirements are delivered according to determined schedules
• Fosters a safe working environment through appropriate training and engagement of QC staff
• Assures policies, practices, standard work are consistent across the department
• Conducts group communication meetings to facilitate project efficiency and/or distribute information
• Develops and manages group against KPI's to assure alignment with objectives and manage to target
• Participates in the development and management of capital and expense budget
• Participates in and develops employee development plans to assure continuity to mid- and long-term succession plans
• Manages and develops direct and indirect reports
• 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.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor's degree in Biology, chemistry or related field with 11+ years of relevant experience OR
• MS degree with 9+ years of relevant experience OR
• Ph.D. with 7+ years of relevant experience
• 4+ years of people management and leadership experience
• Experience working in a regulated GMP environment
• Experience managing and developing direct reports and teams
• Experience with QC Methods

Preferred Requirements:

• 8+ years of experience working in a regulated GMP environment
• Extensive experience with Drug Product production
• Experience working in a contract manufacturing or testing organization
• Experience with statistical experimental design and data analysis with JMP software
• Experience with QC Microbiology methods, Raw Material testing and contamination control

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 240 minutes.

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

Ability to sit for prolonged periods of time up to 240 minutes.

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

Will work in warm/cold environments

Will work in heights greater than 4 feet.

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 ([email protected]).