Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

The Training Manager will be responsible for the oversight of the training program through the design, implementation, maintenance, and continual improvement of the training program for all Rocket employees. The scope of this role includes the eQMS / eLMS administration and partners with cross-functional teams to help them deliver required training to the Rocket employees. The role is primarily focused on the effectiveness and compliance of Rocket’s training strategies and requirements. This position reports to the Director – Quality Assurance QMS.

1. Manage training program in line with applicable health authority guidelines, regulations, quality performance indicator and compliance trends, and operational needs.
2. Create and maintain training materials, curricula, learning paths at Rocket. Collaborate with cross functional teams to ensure 100% training compliance based on approved training curricula and periodically review such training curricula with each functional team from life-cycle perspective for accuracy.
3. 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.
4. 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.
5. 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.
6. Act as an eQMS “superuser” to meet day-to-day eQMS support needs based on communication from Rocket employees. Improve overall training experience at all levels across Rocket by partnering with respective functional teams to address their training needs on an ongoing basis.
7. 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.
8. 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.
9. Support Quality Culture enhancement efforts, lead the training sessions by delivering such training and manage the periodic events organized for overall quality improvements.
10. 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.
11. 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.

• Bachelor’s degree, preferably in Life Sciences
• 8-10 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) is required. 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%.

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.