Manager QA Learning
Manager QA Learning
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1 Vacancy
Job Description
Position Overview
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 sites 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 sites Quality Learning System.
Company Overview
Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a newlargescale 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 endtoend cell culture CDMO provider in North America.
The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.
Job Description
Major Accountabilities:
Develops creates and implements learning strategies and programs that align with the organizations quality objectives. This includes
understanding the site CGMP specific training needs related to quality assurance regulatory compliance and operational excellence.
Owns and manages the sites eTraining/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 sites learning programs.
Tracks training effectiveness by monitoring competency assessments evaluating posttraining 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 inhouse knowledge including procedures and continually shares knowledge with all sites.
Manages develops and hires the Learning team according to the sites 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 elearning 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:
Bachelors degree in science or engineering field with 8 years of experience in a GMP environment OR
Masters 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 elearning 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.
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 viaemail 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.
EEO Information
Fujifilm is committedto 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.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().
Required Experience:
Manager
Employment Type
Unclear
