Position OverviewSet the quality bar for a site that manufactures tomorrow's therapies. As Senior Director, QA, you will sit on both the Site Leadership Team (SLT) and the Global QA Leadership Team-shaping site quality aspirations, executing the global QA strategy, and hardwiring inspection readiness into daily operations. You'll lead Quality Operations, Quality Systems, Quality Training, and Supplier Qualification, ensuring harmonized, compliant Quality Systems that keep our license to operate strong and our clients confident. If you're an executive QA leader who builds high-performing teams and delivers excellence in a 24/7 GMP environment, this is your moment to make a lasting impact.
Job DescriptionWhy this role matters
- License to operate: Your strategy and leadership will drive FDA/EU/MHRA compliance, inspection outcomes, and the trust that underpins every batch we release.
- Global influence, local execution: Operate at the intersection of site excellence and global harmonization-aligning site operations with enterprise QA standards across the US, UK, and Denmark.
- People and performance: Build, mentor, and scale a high-performing QA organization; define KPIs and governance that elevate quality system maturity and accelerate continuous improvement.
What you'll lead and deliver
- Define and execute the site QA strategy aligned with corporate goals and regulatory standards; ensure readiness for regulatory inspections and customer audits.
- Lead and mentor a high-performing QA organization (Quality Operations, Quality Systems, Quality Training, Supplier Qualification), collaborating with the global QA function to ensure alignment and impact.
- Guide the evolution of QA capabilities-ensuring the team has the technical depth and compliance systems to meet current and emerging regulatory requirements.
- Oversee regulatory inspections and interactions; participate in customer visits and audits in collaboration with the Customer Quality function; ensure robust inspection management and follow-up.
- Ensure sufficient resources and build high-trust relationships with partners; identify cost-saving opportunities while maintaining compliance and quality standards.
- Champion site development and expansion through leadership aspirations; role model FUJIFILM Diosynth Biotechnologies (FDB) values.
- Adhere to enterprise KPIs; establish actionable site-level KPIs and quality governance processes that drive continuous, effective improvements to quality systems locally and globally.
- Build and maintain strong networks with internal site partners, global counterparts (US, Denmark, UK), external partners, and customers as needed.
- Collaborate cross-functionally; provide leadership and guidance to assigned project teams to deliver quality outcomes on time.
- Manage and develop direct reports within QA; conduct performance management and coaching to build future-ready talent.
- Administer and enforce company policies (e.g., time off, shift work, inclement weather) and complete required administrative tasks (timecards, PTO approvals, expense reports).
- Coach the team to foster professional development and long-term success; drive recruitment and retention strategies to attract and keep top talent.
- Evaluate team performance; address gaps, questions, and concerns; partner with HR to resolve issues and implement measures that improve productivity and engagement.
- Perform other duties as assigned.
Minimum education and experience requirements
- Master's degree in Life Science, Pharmaceuticals, or a similar field with 13+ years of QA experience in the biopharmaceutical or biotech industry; OR
- Bachelor's degree in Science, Engineering, Life Science, Pharmaceuticals, or a similar field with 15+ years of QA experience in the biopharmaceutical or biotech industry.
- 12+ years of people management, leadership, and team management experience.
- Prior experience in a GMP environment working with FDA, EU, and MHRA regulations.
- Must be flexible to support a 24/7 manufacturing facility.
Preferred education, training, and experience
- Degree in Science, Engineering, or a similar field.
- Lean Six Sigma or other certification.
What you'll bring to thrive
- Ability to coach, lead, and develop individual contributors; proven success hiring and developing top talent and allocating resources effectively.
- Willingness and ability to partner across global colleagues and cross-functional teams to meet company and department goals.
- Executive presence with adaptive communication skills; able to advise on complex matters and present sophisticated information clearly to varied audiences.
- Strong attention to detail, high organization, and a solution-oriented mindset; skilled at navigating crucial conversations.
- Effective written and oral communication; able to influence and lead across the site and enterprise.
Leadership scope and impact
- Operates with executive-level discretion-establishing broader company strategy for QA and translating it into multi-functional objectives.
- Decisions carry long-term impact (five years or longer) on company success.
- Interacts with executive-level management on critical matters; influences policy-making and strategy; recognized as an influential leader.
- Leads one or more functional areas through subordinate directors/managers; oversees development of new methods to solve site- and company-wide challenges.
- Team size: approximately 4-8 direct reports and 15-25 indirect reports.
Working environment and physical requirements
- Ability to discern audible cues and perform tasks with 20/20 corrected vision, including distinguishing color.
- Ability to stand and/or sit for prolonged periods (up to ~120 minutes), perform repetitive motions of wrists/hands/fingers.
- Ability to move objects up to 33 lbs; bend, push/pull, and reach 18"-60"; use twisting motions.
- May work in mechanical/production spaces that require hearing protection and enrollment in a hearing conservation program.
- Adheres to site EHS, security, and safety protocols.
Your impact from day one
- Elevate inspection readiness and product quality through disciplined governance, empowered teams, and harmonized systems.
- Set a clear quality vision for the site and translate it into measurable performance-reducing risk, enhancing client trust, and accelerating growth.
- Develop leaders and culture-ensuring the QA organization is a beacon for excellence and a partner to operations.
Ready to lead quality for a site making life-changing therapies? Apply now to become the Senior Director, QA at our Morrisville, NC site.
