Senior Director, Quality Control

Overview

The Senior 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 including: Product Testing, Microbiology, Sample Management, Stability, External Laboratories oversight, QC Systems, Results and Reporting. 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 FDBC site and quality organization.

 

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 dotted reporting line to the VP of Global Quality Control.

External US

The work we do at FUJIFILM Diosynth Biotechnologies (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. 

 

Main Activities and Responsibilities

• Lead and develop a team of individuals in alignment with department’s objectives
• Provides strategic decision-making, prioritize deliverables to meet site and compliance objectives
• Contribute to site goals, managing budget and personnel
• Support cGMP manufacture, development, analytical testing, and supply of cell therapy products
• Develop and sustain key QC performance indicators and metrics
• Develop phase-appropriate method development, testing capabilities, equipment readiness, business processes, and procedures
• Strategize and ensure a harmonized approach to analytical method implementation and lifecycle, including method development, transfer, verification, qualification, validation and improvements
• Improve laboratory processes and procedures
• Ensure implementation of laboratory systems and equipment
• Ensure testing oversight for in-process, release, stability, validation, comparability studies and environmental monitoring
• Maintain current knowledge of regulations, corporate policies, industry best practices, trends, and standards to ensure that the QC remains in compliance with applicable company requirements and global regulations
• Interact with the site management team to identify QC requirements in support of New Product Introduction, capacity models, and process improvements
• Support laboratory investigations and trend investigations, including the identification of Corrective/Preventive Actions
• Prepare and participate of site inspections from regulatory agencies, partners and/or clients
• Partner with contract laboratories to enable method implementation and/or resolve issues
• Collaborate with client Quality teams to identify appropriate analytical controls, review of Quality agreements, and assist with third-party contractor evaluations
• All other duties as assigned.

 

Physical Demands:

Subject to extended period of sitting and/or standing, vision to monitor. Work is generally performed in an office or laboratory environment.

 

Background Requirements, Education, and Qualifications:

• 12+ years of team management experience preferred
• Bachelor of Science (B.Sc.) with 17+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 12+ years of experience; or PhD in Science with 10+ years of experience.
• Technical and regulatory understanding of biologics, gene, or cell therapy QC with an understanding of the control strategy
• Ability to work in a fast paced and dynamic environment, manage multiple competing priorities while driving all projects forward and meeting program/project deliverables
• Strong leadership, collaboration, team building, program management and organizational skills
• Proven ability to develop, communicate, and execute plans and strategies with a wide range o