Director of Global QC/Raw Materials

Overview

The Director of Global QC Materials is accountable for high GMP service and support level within QC as well as with applicable stakeholders outside of Quality Control within FUJIFILM Diosynth Biotechnologies. They are accountable for GMP compliant support systems according to EU GMP (Eudralex volume 4, Part 1 and 2), 21CFR part 210, 211, 820,11 and other applicable GMP guidelines. They will manage and develop the Global QC Materials management team and department.

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. 

 

Responsible for driving development and implementing the FDB global QC material strategy, the Director of Global QC Materials will set the direction and execute the strategy according to plan with global FDB stakeholders, to ensure our KojoX strategy. They will ensure continued focus on identification, improvements and implementation of optimizations across FDB Global QC. The Director will continuously work with the management team to make sure that we put people first, and that we have motivated and engaged employees and we ensure we are an employer of choice.

 

Reporting directly to the VP of Quality Control (Global), this role can have 1-5 direct reports, with the possibility of having 20-50 indirect reports.

 

Main Activities and Responsibilities:

• Create a common/standard for material documentation requirements, assessments and testing strategy across the Company
• Lead and develop a team responsible for driving, supporting, and improving the way we work with material strategy across FDB to ensure shared material strategy
• Develop and implement the global material strategy to optimize work with our internal and external stakeholders, to support KojoX
• Execute managerial tasks per the Company policies (e.g. Workday, compensation, 1:1 etc.)
• Oversee and responsible for the tech transfer area related to materials in QC (agreement with customers, specs. SJR reports etc.)
• Ensuring compliance on materials regarding customer, vendor and regulatory requirements
• Ensure continued improvement and capacity development via the QC materials network
• Enforce established policies, processes and procedures and identifies areas where enhancements will improve daily work.
• Cross functional collaboration and project team leadership assignments consistent with personal strategic, operational and technical leadership.
• All other duties as assigned.

The Director of QC Materials is accountable for GMP compliance for materials according to USP, EU GMP (part 1 and 2), 21 CFR part 210, 211, 820, 11 and other applicable GMP guidelines. Although with no direct budgetary responsibilities, they will provide input to the overall Global QC budget.

 

This role has a direct impact on the global strategy for QC materials and responsibility for the performance and quality of QC materials related activities in the tech transfer process. They interact closely with global internal and external stakeholders to ensure alignments are made across teams as part of the shared materials strategy and KojoX vision including level loading of resources where needed. This role will oversee a highly complex team with many responsibilities and stakeholders in many departments and direct relations to customers and vendors.  

 

In collaboration with Global QC management team, you will make decisions regarding:

• Quality issues and complex investigations
• Development and building the Global QC material strategy and organization
• People management and development

Background Requirements and Education:

• Master’s Degree in one of the following areas: Analytical Chemistry, Organic Chemistry, Pharmacy or similar
• 8+ years of experience with analytical testing (preferably raw material testing and release), GMP experience, Drug Product requirements  
• 5+ years management experience
• Leadership experience and capabilities
• Strong ability to prioritize work and activities, and give overall direction
• Excellent people management skills
• Coaching skills including meeting every employee on the level needed – adaptable to team members’ style of working
• Project management skills