Associate Director, QC Biological (Microbiology Focused)

Associate Director, QC Biological (Microbiology Focused) Position Overview The Associate Director, QC Biological is responsible for management of multiple labs within the Quality Control department including QC Microbiology. The individual will act as a representative of QC in cross‑functional meetings 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, resolving conflict and prioritizing work as necessary. The Associate Director, QC Biological will manage through levels including managers, supervisors, individual contributors, etc. Job Description What You’ll Do Translate company goals into relevant department objectives, focused on assuring compliance, supply, profit plan, strategy, and people/culture objectives are appropriately implemented Provide logistical and strategic support for achieving department objectives Represent the department for manufacturing, customer, and COE related activities as they relate to resource management Assure the laboratory is capable of delivering to proposed or scoped customer requirements Assure adherence to headcount and budget plans Initiate and drive implementation of technology and projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality/safety enhancement. Foster an environment for continuous improvement Maintain state of inspectional readiness for the department Assure appropriate training requirements are established and that staff maintain currency to the curricula Assure team delivers on‑time results with right first‑time quality Make decisions on equipment selection, qualification, maintenance Assure transferred methods align with department analytical platforms Provide training and assurance that transferred methods are fit for purpose and QC personnel are trained to perform them consistently Assure Quality System requirements are delivered according to determined schedules Foster a safe working environment through appropriate training and engagement of QC staff Assure policies, practices, standard work are consistent across the department Conduct group communication meetings to facilitate project efficiency and/or distribute information Develop and manage group against KPI’s to assure alignment with objectives and manage to target Participate in the development and management of capital and expense budget Participate in and develop employee development plans to assure continuity to mid- and long-term succession plans Manage and develop direct and indirect reports Administer company policies such as time off, shift work, and inclement weather that directly impact employees Complete required administrative tasks (e.g., timecard approvals, time off approvals, expense reports, etc.) Coach and guide direct reports to foster professional development Participate in the recruitment process and retention strategies to attract and retain talent, as needed Address performance gaps, employee questions and concerns, and partner with HR as needed for resolution Perform 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 forms, 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 (View email address on click.appcast.io). #J-18808-Ljbffr NCBiotech