Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

The Manager, QA Learning is responsible for agile quality partnerships that proactively assure Quality and cGMP Compliance. The Manager, QA Learning applies their technical expertise and business knowledge to establish and leverage the most appropriate learning strategies, creating programs that deliver engaging learning experiences while maintaining operational compliance. This role utilizes both internal and external resources to develop and implement various learning methods companywide. This role serves as a key resource in customer audits and external regulatory inspections, such as those conducted by the EMA and FDA. Thisrole is responsible for direct reports whose function is to execute and manage the site's operational systems the Quality function delivers and maintains a compliant training program. The Manager, QA Learning acts asthe learning lead for GxP training and system manager for the site's Quality Learning System.

Major Accountabilities:

• Develops, creates, and implements learning strategies and programs that align with the organization's quality objectives. This includes
understanding the site CGMP specific training needs related to quality assurance, regulatory compliance, and operational excellence.
• Owns and manages the site's e-Training/Learning System, including training metrics. Partners with key stakeholders and end users.
• Conducts regular assessments to identify gaps in skills and knowledge related to quality processes and evaluates opportunities to improve the site's learning programs.
• Tracks training effectiveness by monitoring competency assessments, evaluating post-training performance, and adjusting as needed.
• Ensures that all training programs comply with industry regulations and company policies.
• Collaborate with quality teams to identify critical quality metrics and areas for improvement through training.
• Collaborates with other sites to leverage in-house knowledge, including procedures, and continually shares knowledge with all sites.
• Manages, develops, and hires the Learning team according to the site's Learning and Development plan, setting priorities aligned with strategic and departmental goals.
• Provides mentorship, coaching, and guidance to the QA learning team to enhance their ability to facilitate, collaborate, and implement training programs effectively.
• Manages Learning Systems and timelines and presents the program at audits and inspections.
• Drives ongoing continuous improvement of LMS (Compliance Wire)
• Leverages learning management systems (LMS) to manage training materials, track progress, and deliver e-learning modules.
• Supports management activities related to compliance with policies, appropriate personnel training, providing feedback for personnel
development, and effective and timely decision making/corrective actions on the floor.
• Ensures the timely delivery of results within deadlines by effectively managing the performance of the QA learning team.
• Performs other duties as assigned.

Minimum Requirements:

• Bachelor’s degree in science or engineering field with 8+ years of experience in a GMP environment OR
• Master’s Degree science or engineering with 6+ years of experience in GMP environment OR
• Ph.D. with 4+ years of experience in GMP environment
• 2- 3 years management experience
• Experience in a cGMP environment connected to GxP training material.

• 5+ years of experience in Training, Technical Training Development, etc. with a focus on content design, delivery and program
management
• Experience in strategic consulting, learning needs analysis, instructional design, development and delivery, behavioral
assessments, team development, and other learning and development interventions
• Proven needs analysis, instructional design, monitoring, and classroom training skills
• Excellent organizational and multitasking capabilities and ability to work cross functionally across all levels of the organization.
• Experience with e-learning platforms and systems implementation for the pharmaceutical industry.

Preferred Requirements:

• Design experience preferred for development of interactive training materials.
• Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills.

Working Environment:

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

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

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

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

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

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

Will work in warm/cold environments. 

Will work in outdoor elements such as a precipitation and wind.

FDBN 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 email FDBN_PNC@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.