FUJIFILM
Associate Director, QC Analytical
FUJIFILM, Holly Springs, North Carolina, United States, 27540
Associate Director, QC Analytical
The Associate Director, QC Analytical is responsible for management of the QC Analytical technology centers of excellence, including hiring plans, budget development, strategic planning, and driving results. This role plans, schedules, and oversees laboratory activities related to meeting compliance, schedule adherence, profit plans, and strategy objectives of the company and the department. The Associate Director, QC Analytical 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 Analytical may have managers, supervisors, individual contributors, and hourly support staff reporting to them. 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 reports from the analytical team 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 Bachelor's degree with 11+ years of relevant experience OR MS degree with 9+ years of relevant experience OR Ph.D. with 7+ years of relevant experience 8+ years of people management and leadership experience Experience working in a regulated GMP environment Experience managing and developing direct reports and teams Extensive experience with Analytical and Cell-based methods 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 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 sit 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 conduct work that includes moving objects up to 10 pounds. 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.
The Associate Director, QC Analytical is responsible for management of the QC Analytical technology centers of excellence, including hiring plans, budget development, strategic planning, and driving results. This role plans, schedules, and oversees laboratory activities related to meeting compliance, schedule adherence, profit plans, and strategy objectives of the company and the department. The Associate Director, QC Analytical 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 Analytical may have managers, supervisors, individual contributors, and hourly support staff reporting to them. 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 reports from the analytical team 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 Bachelor's degree with 11+ years of relevant experience OR MS degree with 9+ years of relevant experience OR Ph.D. with 7+ years of relevant experience 8+ years of people management and leadership experience Experience working in a regulated GMP environment Experience managing and developing direct reports and teams Extensive experience with Analytical and Cell-based methods 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 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 sit 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 conduct work that includes moving objects up to 10 pounds. 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.