Quality Control Operations Support Manager

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki. 

External US

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

The QC Operations Support Manager will manage, maintain, and oversee the day-to-day operations of the Quality Control Coordinators, Sample Management, and Stability Coordinators.   

The Quality Control Operations Support Manager will oversee and manage staff in a multi-functional support role.  This position will require the QC Operational Manager to supervise QC employees staffed in the following areas:  QC Project Coordinators, Sample Management, and Stability Coordinators. The position will also require frequent communication with the Analytical Development and Assay Method Transfer groups to coordinate and schedule method qualification activities.  The QC Operations Manager will ensure all three operational support groups are fully informed and aligned with current and future GMP processes, to include stability studies, release testing, project scheduling, and company milestones.  Close attention to detail and good organizational skills are essential to ensure QC Operations meet department and company goals. Other responsibilities may include but are not limited to: Compiling data for Batch Disposition.  Attending planning meetings as needed.  Communicating gaps and schedule changes to QC Area Managers.  

Reports to                Associate Director, Quality Control

Work Location         College Station, TX 

Primary Responsibilities:

• Work with QC Coordinators and QC Managers to ensure testing schedules are built out and adhered to in support of in-process, release, outsource and stability samples.
• Work directly with the QC Managers and Smart QC vendor to build out and maintain the testing database.
• Provide support to QC coordinators and Project Managers to ensure client meetings are productive and ensure proper updates are provided in a timely manner.
• Prepare QC metrics on a monthly basis.
• Work with Raw Materials staff to improve and provide support on raw material receipt and storage.
• Work directly with customers to update and confirm schedules and deadlines. Assist in mitigating delays in project timelines. 
• Oversee Sample Management staff to provide guidance and support as needed.
• Provide support and oversight to the Stability Coordinator staff to ensure protocols and reports are drafted and distributed in a timely manner.
• Navigate documents through the Master Control process effectively and follow up to ensure customers are updated as needed.
• Attend Tier 2 and QC Tier meetings daily and update QC Staff as needed.
• Assist QC Director and QC Managers to oversee and coordinate departmental training.
• Ability to work cross functionally with Quality Assurance, Manufacturing, and Project Management to establish and maintain project timelines.
• Perform other duties as assigned.

Qualifications:

• Associate’s degree in a scientific discipline with 9 years of relevant experience in the biotechnology or pharmaceutical industry; OR
• Bachelor’s degree in a scientific discipline with 7 years of relevant experience in the biotechnology or pharmaceutical industry; OR
• Master’s degree in a scientific discipline with 5 years of relevant experience in the biotechnology or pharmaceutical industry.
• 4 years of previous managerial or supervisory experience.
• PMP Certificate preferred.
• Knowledge and experience in business, supervision, and management.
• Ability to motivate and support teams in a positive manner.
• Knowledge of the functions, operation, and mission of the specific department.
• Demonstrated ability to lead and develop a department and department staff members.
• Must be highly organized, driven, and possess the skills and capability to plan ahead and stay on schedule.
• Ability to evolve and adapt to new technologies to include electronic planning tools and Laboratory Information Management Systems (LIMS).
• Computer skills a must-Microsoft Office and Microsoft Project.
• Ability to multi-task and prioritize work assignments.
• Excellent attention to detail.
• Excellent analytical and planning skills.
• Must have excellent organizational, written, and oral communication skills.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• Ability to wear appropriate PPE as required.
• Lifting up to 20 pounds.
• Onsite attendance is mandatory.

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3500.

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.