The Senior Director, Head of Quality Assurance, is responsible for providing 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 will serve as member of the Site Leadership Team (SLT) and the Global Quality Assurance Leadership team. In this role, it is key to achieve site operational goals, define site quality aspirations, executive the site and global QA strategy as well as contribute to improving the local and global QA systems. 

At FUJIFILM Diosynth Biotechnologies (FDB), an exciting opportunity awaits you to collaborate with some of the most innovative biopharma companies worldwide. Here you will have the chance to learn from some of the most dedicated scientists, engineers, and manufacturers who are deeply committed to making an impact on people’s lives. We are different. We strive for better. Our people never settle for the status quo and as you push the boundaries of your potential, you not only change your life, you change 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’s quality assurance strategy to align with corporate goals and regulatory standards and ensures readiness for regulatory inspections and customer audits (30%)
• Leadership of leaders overseeing the various site Quality Assurance functions and leader of the site  Quality Leadership Team (sQLT). Builds and mentors a high-performing QA team working locally with the global QA organization in mind ensuring alignment with organizational goals. Ensures that sufficient resources are available and that a high level of trust is built and maintained in all partner relations. Ensures flexible work force to drive development and retain talent (25%)
• As a member of the Site Leadership Team (SLT) engaging in the continuous development and expansion of the site through setting leadership aspirations and through being a role model for the Fujifilm and the FDB values (15%)
• Adhere to enterprise-level Key Performance Indicators (KPIs) and additionally establishes and innovate actionable KPIs and quality governance processes to ensure continuous and effective continuous improvements of the quality system across site and in the global organization (15%)
• Builds and maintains strong network to key partners internally, globally (sites in US, Denmark and UK, Customer Quality) as well as external partners and customers as 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's degree Pharmaceutical 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 role includes contact to MRHA, FDA and other regulatory authorities in 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 audits and agency inspections the leadership of this role is essential to maintain clarity of direction for the site. The breadth of leadership in this role is large and the influence thereby extensive. 

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FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran 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 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.