Manager, GxP Learning Management and Instructional Design

1 month ago

Florham Park, United States Celularity Full time
Job DescriptionJob DescriptionDescription:


About Celularity

Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer and immune and infectious diseases. Celularity is developing a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates including T cells engineered with a chimeric antigen receptor ("CAR"), natural killer ("NK") cells, and mesenchymal-like adherent stromal cells ("MLASCs") and exosomes. These therapeutic candidates target indications across cancer, infectious, and degenerative diseases. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.


Summary

The Quality Assurance (QA) Manager, GxP Learning Management and Instructional Design will manage the electronic document and learning management systems and the design, development, implementation and maintenance of training programs/courses at Celularity.


Responsibilities will include, but are not limited to, the following:

  • Administrator of the Learning Management and Documents Management processes within the QMS, providing training/support to system users
  • Creates and maintains, training courses, training curricula and learner role assignments in the LMS
  • Develops and maintains training completion and performance metrics and continuously evaluates the effectiveness of training programs. Tracks status of compliance to training requirements and reports to management periodically or as requested.
  • Assists in the delivery of effective training to adult learners, across multiple functional areas by creating, maintaining and delivering the on-site Train –the- Trainer Training program
  • Assists GxP work areas in developing, implementing, and maintaining On-the-Job Training (OTJ) programs and learning assessments/checklists
  • Partners with subject matter experts to design and develop engaging and effective e-learning courses with valid learning assessments and manages the deployment and follow-up of Instructor-led courses, E-learning, and hybrid courses.
  • Designs, develops, and facilitates/delivers annual, general GxP concept training based on business needs
  • Designs, develops, and facilitates/delivers New Hire orientation learning program
  • Evaluates training needs and participates in the acquisition or development of training materials company-wide. Selects appropriate instructional technologies and learning assessment tools to enhance learning outcomes.
  • Collaborate with the business to analyze and understand learning needs.
  • Utilize instructional design principles to create engaging and effective learning experiences.
  • Incorporate adult learning theories and best practices in instructional design.
  • Stay updated on industry trends and advancements in instructional design.
  • Ensure alignment of instructional materials with learning objectives and organizational goals.
  • Works closely with stakeholders to gather feedback and make continuous improvements.
  • Manages projects, timelines, and resources effectively to meet deadlines.
  • Provides an exemplary customer-centric experience resulting in the highest level of customer satisfaction.
  • Manages time-sensitive material and version control to ensure documents are in place and timely.
  • Performs other QA duties as assigned.
Requirements:

Education and Experience

  • Bachelor's degree in a Life Science with certification/concentration in Instructional Design; with 5+ years working as an instructional designer; and 5+ years working with quality systems within a GXP regulated field or function.

Basic & Preferred Qualifications

  • 5+ years hands-on experience with using instructional design tools to create effective learning materials and learning assessments.
  • 5+ year hands-on experience working with learning management and document management systems.
  • Excellent computer skills with solid experience in MS Office
  • Excellent customer service, interpersonal, and conflict management skills.
  • Calm, composed demeanor to deal with multiple and, at times, conflicting priorities.
  • Demonstrated empathy and care with an open, customer-centric mindset when resolving customers' inquiries.
  • Critical thinker and problem solver with a professional 'can do it' attitude.
  • Effective problem-solving, and analytical skills.
  • Ability to work independently with strong time management and organization skills and the ability to thrive, and work with others in a team-based, environment.
  • Consistently show a sense of urgency in performing duties with the ability to balance multiple priorities and constantly changing workloads.
  • Ability to keep the highest standards of accuracy, precision, discretion, and confidentiality with strong ethical values.
  • Ability to learn, follow procedures/instructions, and adapt in a regulated environment
  • Excellent written and verbal communication skills; communicate results and issues effectively


Working Conditions

  • The incumbent will be working in an office environment

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.


This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities considered incidental or secondary to this job's overall purpose. Employees/contractors holding this position will be required to perform any other job-related duties as requested by management.


Must be authorized to work directly for Celularity in the U.S.


No agency submittals accepted through this website.


Celularity Inc. is an equal opportunity employer


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