Associate Director, Quality Control (Microbiology)

Position Overview

The Associate Director, Quality Control (Microbiology) is responsible for the effective management of the Quality Control Microbiology team to assure on time analysis of manufactured product and environmental monitoring samples.  Responsible to assure all testing is performed in compliance with applicable regulations, company specifications, procedures, and policies at Fujifilm Diosynth Biotechnologies.

 

The Associate Director, Quality Control (Microbiology) is the site SME for Microbiology, with oversight of microbial and environmental control in the manufacturing facility. The roles plays a key partnership with manufacturing operations through trend identification, best practice establishment and continual improvement of operations.

 

The Associate Director, Quality Control (Microbiology) is key to creating an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross-functionally to deliver exceptional results and ensure long-term business success. This role is essential to the success of the wider QC function, working in collaboration with peers to deliver the wider QC strategic plan.

Company Overview

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

Job Description

What You'll Do: 

 

• Creates a safe working environment within QC through a culture of behavioral safety and adherence to site EHS policies and procedures.
• Ensures team are actively engaged in the on-time delivery of routine operations and annual objectives.
• Maintains the QC Laboratories in a state of audit readiness, presents on QC topics and leads tours for client and regulatory inspections.
• Manages the team for excellence in laboratory investigations, on time completion of CAPA and Change Control.
• Assures appropriate team training requirements are established and compliance to assigned curricula.
• Oversight of microbial and environmental control in the manufacturing facility.
• Champion for Continuous Improvement providing the resources and developing the team to evaluate and improve upon current state.
• Invested in the development and actively manages performance of individuals.
• Adherence to QC expense and capital budget
• May supervise 10 or more exempt or non-exempt staff.
• Contribute to the development of the capital and expense budget and have approval authorities as defined in the company's authorization matrix.
• Responsible for managing the department activities in a manner that meets or exceeds the company objectives regarding revenue, profit plan, supply, and compliance.

 

Minimum Requirements: 

• Bachelor of Science in Microbiology or related technical field and 12+ years of experience
• Knowledge and experience of Bioburden, endotxin and EM testing

 

Preferred Qualifications:

• Master's of Science and 10+ years OR PhD and 8+ years of experience in GMP laboratory environment
• 5 years of supervisory experience
• Experience working in a lean manufacturing or six sigma environment
• Experience with LIMS and other data management systems 

 

Specific Skills and Competencies:

 

• Demonstrated leadership, technical aptitude, and problem-solving skills
• Adaptable and able to manage and prioritize multiple tasks and assignments.
• Excellent verbal and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.
• Demonstrated capability in a cross-functional team environment, working cooperativel