Associate Director, QC Biological

Fujifilm•Holly Springs, NC

About The Position

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: https://www.fujifilm.com/us/en/about/region/careers Job Description What You'll Do

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
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.

Nice To Haves

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

Responsibilities

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