QA Learning Manager

The Quality Assurance Learning Manager, will work through agile quality partnerships that proactively assure Quality and cGMP Compliance. This role is key to our culture and continued operational excellence. QA Learning Manager for the FDBN site applies their technical expertise and business knowledge to establish and leverage the most appropriate learning strategy for the FDB Holly Springs, NC site; with the ultimate goal of establishing programs that deliver exciting learning experiences, while maintaining operational compliance. This role will utilize both internal and external resources for the purpose of developing and implementing various learning methods companywide. The QA Learning Manager is a key resource in customer audits and external regulatory inspections i.e. EMA and FDA. The ideal candidate will be responsible for direct reports whose function is to execute and manage the sites operational systems against the sites strategic learning plan. This position is the learning lead and system manager for the sites Quality Department.

External US

Responsibilities

• Develop, implement and conduct the sites cGMP training program.


• Own and manage the sites e-Training System including training metrics. Continually partner with key stakeholders and end users.


• Continually evaluate opportunities to improve the sites learning programs.   


• Collaborate with the existing FDB sites to leverage inhouse knowledge including procedures and continually share knowledge with all FDB sites.


• Manage, develop, and hire Learning Systems team in line with the sites Learning and Development plan. Set priorities for direct reports in conjunction with the sites strategic plan and departmental goals.


• Manage Learning Systems including budget and timelines. 


• International and domestic travel required


• You should expect the role and responsibilities to develop and evolve as the project group expands, and subsequently moves into operations.

Position Requirements

• Bachelor's Degree in Education or equivalent with experience in the pharmaceutical industries with emphasis on training is preferred. Human and operational performance knowledge is a strong advantage (preferred).


• Bring contagious positive enthusiasm and an agile proactive mindset to Learning Systems.


• Excellent oral and written communication skills, and excellent public speaking ability


• Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills.


• Knowledge and application of cGMP compliance and other related regulations


• Experience with e-learning platforms and systems applicable to the pharmaceutical industry.


• Ability to work in a challenging environment with frequent interruptions, changing priorities and deadlines


• Ability to identify and creatively resolve multi-disciplinary conflicts


• Demonstrated success facilitating and /or lead cross functional teams to consensus


• Ability to design interactive training materials. 

The Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.

FDBN works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

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 lena.lee@fujifilm.com.