The Sr. Director, Quality Control provides strategic, technical, and operational leadership to the site Quality Control Laboratories. This role proactively leads implementation of GMP industry standard methodologies across the Quality Control Laboratories. The Sr. Director, Quality Control plays a major role in the site operations while remaining adaptable to the changing needs for new clients and programs and is accountable for the sustained and ever improving quality mindset as well as the consistent adherence to current good manufacturing practices (cGMP) throughout the site.

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

What You'll Do:

• Develops and implements the strategy and roadmap for Quality Control at the Morrisville site, with the overall Global Quality Strategy generated at a global collaboration
• Builds, develops and leads the QC team with intention, providing clear priorities, feedback and career development opportunities in alignment with the department’s objectives
• Leads the growth and expansion of the QC team at the site including regional accountabilities for intra-company testing to support the Holly Springs site and additional sites
• Provides strategic decision-making; prioritizes deliverables to meet site and compliance objectives
• Oversees all QC operations including, In Process Testing, Bulk Release and Stability Testing, Microbiological Testing, the Environmental and Utility Monitoring program
• Supports and participates in client visits, audits, and regulatory agency inspections
• Ensures budgets, timelines, schedules and performance requirements are established and met
• Assures all areas of responsibility conform to cGMP and other appropriate regulatory
• Interacts and meets regularly with cross-functional leaders on matters concerning their functional areas, groups or clients
• Assures that all areas of responsibility are cGMP compliant and audit-ready
• Oversees the development and implementation of standards, methods and procedures for testing and evaluating the quality and safety of products
• Manages technology transfers and method improvements needed to assure reliable, robust, fit for purpose, and cGMP compliant methods available for the laboratories
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs all other duties, as assigned

Minimum Requirements: 

• Bachelor’s Degree in Chemistry, Biochemistry, Microbiology or related field with 15+ years of experience OR
• Master of Science (M.Sc.) in a related discipline with 13+ years of experience OR
• Ph.D. in Science with 11+ years of experience
• 12+ years of people management, leadership, and team management experience
• Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an understanding of control strategy
• Experience leading client site visits, audits, and regulatory inspections
• Experience managing in a matrix organization and collaborating at a global level
• Experience working in a regulated GMP environment

Preferred Qualifications: 

• 12+ years of experience working in a regulated GMP environment

Knowledge, Skills, or Abilities: 

• Strong orientation for quality, compliance, business ethics and customer service.
• Strong leadership, collaboration, team building, program management and organizational skills
• Proven ability to develop, communicate, and execute plans and strategies with a wide range of stakeholders
• High level of integrity and a drive for continuous improvement
• Strong collaboration and team building skills
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution
• Excellent interpersonal, organizational, and written and oral communication skills
• Mastery knowledge of document management and lifecycle, and quality systems and their interconnections
• Mastery of GMP, regulations, and inspection/audit readiness
• Ability to coach, lead, and develop individual contributors
• Must be flexible to support 24/7 manufacturing facility

Working & Physical Conditions

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. 

Ability to discern audible cues.

Ability to sit for prolonged periods of time up to 60 minutes.

Ability to conduct activities using repetitive motions that include wrists, hands or fingers.

Ability to conduct work that includes moving objects up to 10 pounds. 

*#LI-onsite

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.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com).