Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

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 manufacture 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 we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

The Sr. Director of Quality Control provides strategic, technical, and operational leadership to the site Quality Control Laboratories. The individual will proactively lead implementation of GMP industry standard methodologies across the Quality Control Laboratories. The individual will play a major role in the site operations while remaining adaptable to the changing needs for new clients and programs. They are accountable for the sustained and ever improving quality mindset as well as the consistent adherence to current good manufacturing practices (cGMP) throughout the site.

Through leadership, the incumbent will strive to build a highly motivated and inspired workforce and always build out a strong leadership pipeline with a special focus on succession planning through a strong quality culture throughout the Holly Springs, North Carolina site and quality organization. They will provide direction to project teams, identifying issues and recommending solutions. They are accountable for the accomplishment of agreed milestones to meet Company timelines and meet established budgets. They will work to coordinate and harmonize activities and policies between departments at the site as well as within all FDB.

As of the Sr. Director of QC, you will have a key role in close collaboration with FDB QC peers and VP of global QC to create and implement the QC strategy for our new facility. You will be accountable for delivery of all QC programs, projects and laboratory operations, ensuring staff remain on task and execution is aligned with internal/external customer expectations, regulatory expectations and with industry best practices.

This role will sit on the site leadership team (SLT) and is responsible for leading the site alongside the peers at the SLT and with a strong collaboration and a direct reporting line to the VP of Global Quality Control.

•Develops and implements the strategy and roadmap for Quality Control at the Holly Springs site, with the overall Global Quality Strategy generated at a global collaboration
•Builds, develops and leads the QC team with intention, providing clear priorities, feedback and career development opportunities in alignment with the department’s objectives
•Creates and transitions the QC department to a new state of the art laboratory
•Leads the growth and expansion of the QC team at the site including regional accountabilities for intra-company testing to support the Holly Springs site and additional sites
•Provides strategic decision-making; prioritizes deliverables to meet site and compliance objectives
•Oversees all QC operations including, In Process Testing, Bulk Release and Stability Testing, Microbiological Testing, the Environmental and Utility Monitoring program
•Supports and participates in client visits, audits, and regulatory agency inspections
•Ensures budgets, timelines, schedules and performance requirements are established and met
•Assures all areas of responsibility conform to cGMP and other appropriate regulatory
•Interacts and meets regularly with cross-functional leaders on matters concerning their functional areas, groups or clients
•Assures that all areas of responsibility are cGMP compliant and audit-ready
•Oversees the development and implementation of standards, methods and procedures for testing and evaluating the quality and safety of products
•Manages technology transfers and method improvements needed to assure reliable, robust, fit for purpose, and cGMP compliant methods available for the laboratories
•Performs all other duties, as assigned

Requirements

•Bachelor’s Degree in Chemistry, Biochemistry, Microbiology or related field with 15+ years of experience OR
•Master of Science (M.Sc.) in a related discipline with 13+ years of experience OR
•PhD in Science with 10+ years of experience
•At least 7 years of leadership/management experience
•Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an understanding of control strategy
•Experience leading client site visits, audits, and regulatory inspections

•12 years of leadership experience preferred

PHYSICAL DEMANDS
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes