**Overview** The Senior Director, Head of Quality Assurance,is responsible forproviding strategic leadership in the development and assurance of compliance with local and global, harmonized Quality Systems from our Research Triangle Park (RTP), North Carolina Location. In this role, you willserveas memberof the Site Leadership Team (SLT)and the Global Quality Assurance Leadership team. In this role, it is key to achieve site operational goals,definesitequalityaspirations, executive thesite and global QAstrategyas well as contribute to improving thelocal andglobal QA systems. **External US** At FUJIFILM Diosynth Biotechnologies (FDB), an exciting opportunity awaits you to collaborate with some of the most innovative biopharma companies worldwide. Hereyou willhave the chance to learnfrom some of the most dedicated scientists, engineers, and manufacturers who are deeply committed to making an impact on people’s lives.We aredifferent. We strive for better. Our people neversettle for the status quo and as you push the boundaries of your potential, you not only change your life,youchange others’ too. Join our RTP, NC facility as the Senior Director of Quality Assurance. In this role, you will fully support this facility while being a member of the Global Quality Assurance Organization, implementing the global strategy at the local level. You will ensure adherence to regulatory standards while setting the direction for cGMP compliance and quality assurance, while fostering continuous improvement in the quality culture. You will lead the quality assurance functions, including Heads of Quality Operations, Quality Systems, Quality Training (Learning) and Supplier Qualification. You will be responsible for all regulatory inspections and interactions, and participation in customer visits and audits in collaboration with the Customer Quality function, all of which are essential to sustaining a viable pharmaceutical business. Principal Accountabilities: + Develops and drives the organization’squality assurance strategy to align with corporate goals and regulatory standardsand ensures readiness for regulatory inspections and customer audits(30%) + Leadership of leaders overseeing the varioussiteQuality Assurancefunctionsandleaderof thesite QualityLeadership Team (sQLT).Builds and mentorsa high-performing QA team working locally with the global QA organization in mind ensuring alignment with organizational goals.Ensures that sufficientresourcesare available and thata high levelof trust is built andmaintainedin allpartner relations. Ensures flexible work force to drive development andretaintalent (25%) + As a member of the Site Leadership Team (SLT) engaging in the continuous development and expansion of the site through setting leadershipaspirations and through being a rolemodel forthe Fujifilm and the FDB values(15%) + Adhere toenterprise-level Key Performance Indicators (KPIs)and additionallyestablishesand innovate actionableKPIsand quality governance processesto ensure continuous and effective continuous improvements of the quality systemacross site and in the global organization (15%) + Builds andmaintainsstrong network to key partners internally, globally (sites in US, Denmarkand UK, Customer Quality) as well as external partners and customersas needed(10%) + Can include cross functional collaborate and project team leadership assignment consistent with personal strategic, operational and technical leadership (5%) + All other duties as assigned Minimum Education and Experience Requirements: + Master'sdegreePharmaceutical Science (preferably in Life Sciences, Pharmaceuticals, or a similar field) + 10+ years of experience in Quality Assurance in the biopharmaceutical/biotech industry + 5+ years of leadership experience Knowledge, Skills and Abilities: + Excellent communication skills + Excellent problem solving skills + Experienced in people development and results driven + Excellent project management skills + Excellent strategic thinking and influencing + Innovative thinker + Oriented towards people development and results oriented + Conceptual thinking + Orientation towards efficiency In this role there is broad contact across the site, across the global network, towards partners as well as towards regulatory agencies. The scope of the roleincludes contact toMRHA, FDA and other regulatory authoritiesin matters related to product quality. The impact of this position to the site Quality strategy and site leadership strategy is high. During daily operations as well as during partner auditsand agency inspections the leadership of this role is essential to maintain clarity of direction for the site. The breadthof leadership in this role is large and the influence thereby extensive. ​ FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protectedveteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail HR _FDBU@fujifilm.com To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agenciesto 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 agencieswere 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 agencyengagement process is hired, no fee or payment of any kind will be paid. **Job Locations** _US-NC-Research Triangle Park_ **Posted Date** _4 days ago_ _(1/5/2025 9:24 PM)_ **_Requisition ID_** _2024-32808_ **_Category_** _Quality Assurance_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_