Senior Manager of GxP Learning and Development

Allogene Therapeutics•Newark, NJ

1d•Onsite

About The Position

Allogene is seeking a Senior Manager of GxP Learning and Development to design, implement and provide oversight of the training program to drive training compliance, align training with regulatory expectations and business goals while also supporting individual’s career growth and opportunities. The Learning and Development Manager will be responsible for the development of technical and business-related training materials and programs. This position will require active engagement with organizations across the company to provide expertise and guidance in training strategies and be responsible for the day-to-day administration of our Learning Management System and associated applications. This position will report to the Head of Quality Systems and require on-site presence at both our South San Francisco and Newark Ca. locations.

Requirements

Bachelor of Science Degree in Biological Sciences, Chemistry, Engineering preferred.
Minimum of 8 years in Pharma/Biotech industry including 2-3 years working with a Learning Management System (LMS)
Strong knowledge of GxP, training processes/systems, regulatory requirements for pharmaceutical and biotech commercial manufacturing and supporting activities.
Excellent interpersonal, communication, presentation skills, and classroom facilitation skills.
Collaborative style and customer focus.
Ability to work independently and within a team environment.
Excellent time management and planning skills.
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

Responsibilities

Support driving the learning and talent development strategy across the organization for new hires, employees, managers to enable their continued growth, development, and engagement
Apply instructional design theories/principles to analyze and create training materials which may include Instructor Led, On the Job and eLearning training solutions delivered across multiple training platforms.
Collaborate with functional managers and business owners to determine and develop GxP, compliance and technical training needs, training assignments and curricula.
Approve training material content and design.
Serve as Business Owner and administrator for the Learning Management System (LMS) to ensure system data is accurate and up to date, including, but not limited to running day-to-day operations of the LMS and resolving system related issues.
Partners with stake holders to conduct qualified train-the-trainer sessions when required, including coaching and mentoring.
Identify, escalate, and make recommendations to resolve training compliance gaps.
Generate system reports and metrics for stakeholders on training activities, end-user compliance and internal and external audit inspections.
Ensure training activities align with the company’s goals, policies and best practices.
Lead and participate in special projects and assignments as required.