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.
