Training Manager

Rocket Pharmaceuticals•Cranbury, NJ

3d•$122,000 - $146,000•Onsite

About The Position

Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary The Training Manager oversees Rocket’s training program, including the design, implementation, maintenance, and continual improvement for all employees. This role provides administration of training within the eQMS and eLMS systems and partners with cross-functional teams to deliver required training. The role focuses on ensuring the effectiveness and compliance of Rocket’s training strategies and requirements.

Requirements

Bachelor’s degree, preferably in Life Sciences
5-8 years of work experience in the Quality Assurance department focused on managing Training Program in regulated Biopharma industry, working within quality systems.
Experience with configuration and implementation of eQMS / eLMS (such as ZenQMS, Veeva, Trackwise, ComplianceWire etc).
Experience with training content creation and e-learning tools such as “articulate storyline” to support training content creation (SCORM) and deployment.
Demonstrated ability to design training materials, courses, and well experienced delivering interactive training to various teams across Rocket on a routine basis.
Working knowledge of applicable GxP regulations (ICH/FDA/EU) and guidelines
Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
Detail orientated, with strong communication and organizational skills.
Focused on collaborative work to deliver the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet can work independently when efficiency is required.
Results-oriented individual who is highly motivated, decisive, flexible, and has the creativity to excel in and contribute to a rapidly growing company.
Forward thinking mindset with the ability to manage multiple priorities and identify and resolve issues in a timely manner with minimal guidance.
Ready to work fully onsite to support day-to-day business needs.
Travel requirements up to 10%.

Responsibilities

Manage training program in line with applicable health authority guidelines, regulations, quality performance indicator and compliance trends, and operational needs.
Create and maintain training materials, curricula, learning paths at Rocket.
Collaborate with cross functional teams to ensure training compliance based on approved training curricula and periodically review such training curricula with each functional team from life-cycle perspective for accuracy.
Assess and determine “fit for purpose” training tools and methodologies based on training needs, including (but not limited to) virtual, On-the-Job Training (OJT), and Instructor Led Training (ILT) for each of the training course or a document.
Responsible for content creation and delivery of new hire and periodic refresher training such as GMP training, eQMS workflows overview and data integrity training.
Partner with cross functional teams to create and deliver other GxP and non-GxP training courses such as GCP, GVP and GLP for new hire and refresher training as applicable.
Provide training on eQMS workflows on a routine basis including updates made (if any).
Support additional refresher training needs as identified by cross functional teams or QMS team and maintaining training records.
Monitor training compliance rate across Rocket and report periodic compliance metrics to the leadership including overdue training assignments for individual functional teams as and when requested.
Collaborate with functional teams to help ensure training compliance in the eQMS system at Rocket.
Conduct training needs assessments covering functional needs as well as existing Rocket procedures and ensure timely completion of the design, development, scheduling, and delivery of the designed training courses.
Support Quality Culture enhancement efforts, lead the training sessions by delivering such training and manage the periodic events organized for overall quality improvements.
Accountable for supporting health authority inspections and other audits internally and externally related to the training program and the Quality Management System.
Write responses to the audit observations and track CAPAs till closure of the inspection or an audit.
Support QMS team efforts to update procedures, processes, provide training, and reporting QMS metrics on periodic basis.
Complete other responsibilities, as assigned within the Quality Assurance department.