Training Manager
Rocket Pharmaceuticals
2 months ago
On-site
Cranbury, NJ
Human Resources
Responsibilities:
- Manage the training program in line with applicable health authority guidelines, regulations, quality performance indicators, compliance trends, and operational needs.
- Create and maintain training materials, curricula, and learning paths; collaborate with cross-functional teams to ensure training compliance and periodically review curricula for accuracy.
- Assess and determine “fit for purpose” training tools and methodologies (e.g., virtual, On-the-Job Training (OJT), Instructor Led Training (ILT)).
- Create, deliver, and maintain new hire and periodic refresher training (e.g., GMP, eQMS workflows overview, data integrity); partner to create/deliver GxP and non-GxP training such as GCP, GVP, GLP as applicable.
- Provide routine training on eQMS workflows (including updates); support refresher training needs identified by cross-functional or QMS teams and maintain training records.
- Monitor training compliance rates across Rocket; report compliance metrics to leadership, including overdue assignments; collaborate with functional teams to ensure eQMS training compliance.
- Conduct training needs assessments and ensure timely design, development, scheduling, and delivery of training courses.
- Support quality culture enhancement efforts; lead training sessions and manage periodic quality improvement events.
- Support health authority inspections and internal/external audits related to training and the Quality Management System; respond to observations and track CAPAs to closure.
- Support QMS efforts to update procedures/processes, provide training, and report QMS metrics.
- Perform other duties as assigned within the Quality Assurance department.
Qualifications:
- Bachelor’s degree, preferably in Life Sciences.
- 5–8 years in Quality Assurance managing training programs in regulated biopharma environments within quality systems.
Required/Preferred Skills & Knowledge:
- Experience with configuration/implementation of eQMS/eLMS (e.g., ZenQMS, Veeva, Trackwise, ComplianceWire).
- Training content creation and e-learning tools (e.g., Articulate Storyline; SCORM) and deployment.
- Ability to design training materials/courses and deliver interactive training.
- Working knowledge of GxP regulations and guidelines (ICH/FDA/EU).
- Proficient with Microsoft Word, Excel, and PowerPoint.
- Strong attention to detail, communication, and organizational skills.
- Collaborative mindset with ability to work independently when needed.
- Results-oriented; motivated, decisive, flexible; able to manage multiple priorities and resolve issues with minimal guidance.
- Ability to work fully onsite; travel up to 10%.
Compensation/Benefits (explicitly stated):
- Expected salary range: $122,000–$146,000.
- Competitive total rewards package may include bonuses, medical/dental/vision, life insurance, 401(k) with match, paid vacation/holidays, global shutdown days, wellness resources/support programs, and eligibility for equity awards.
- Manage the training program in line with applicable health authority guidelines, regulations, quality performance indicators, compliance trends, and operational needs.
- Create and maintain training materials, curricula, and learning paths; collaborate with cross-functional teams to ensure training compliance and periodically review curricula for accuracy.
- Assess and determine “fit for purpose” training tools and methodologies (e.g., virtual, On-the-Job Training (OJT), Instructor Led Training (ILT)).
- Create, deliver, and maintain new hire and periodic refresher training (e.g., GMP, eQMS workflows overview, data integrity); partner to create/deliver GxP and non-GxP training such as GCP, GVP, GLP as applicable.
- Provide routine training on eQMS workflows (including updates); support refresher training needs identified by cross-functional or QMS teams and maintain training records.
- Monitor training compliance rates across Rocket; report compliance metrics to leadership, including overdue assignments; collaborate with functional teams to ensure eQMS training compliance.
- Conduct training needs assessments and ensure timely design, development, scheduling, and delivery of training courses.
- Support quality culture enhancement efforts; lead training sessions and manage periodic quality improvement events.
- Support health authority inspections and internal/external audits related to training and the Quality Management System; respond to observations and track CAPAs to closure.
- Support QMS efforts to update procedures/processes, provide training, and report QMS metrics.
- Perform other duties as assigned within the Quality Assurance department.
Qualifications:
- Bachelor’s degree, preferably in Life Sciences.
- 5–8 years in Quality Assurance managing training programs in regulated biopharma environments within quality systems.
Required/Preferred Skills & Knowledge:
- Experience with configuration/implementation of eQMS/eLMS (e.g., ZenQMS, Veeva, Trackwise, ComplianceWire).
- Training content creation and e-learning tools (e.g., Articulate Storyline; SCORM) and deployment.
- Ability to design training materials/courses and deliver interactive training.
- Working knowledge of GxP regulations and guidelines (ICH/FDA/EU).
- Proficient with Microsoft Word, Excel, and PowerPoint.
- Strong attention to detail, communication, and organizational skills.
- Collaborative mindset with ability to work independently when needed.
- Results-oriented; motivated, decisive, flexible; able to manage multiple priorities and resolve issues with minimal guidance.
- Ability to work fully onsite; travel up to 10%.
Compensation/Benefits (explicitly stated):
- Expected salary range: $122,000–$146,000.
- Competitive total rewards package may include bonuses, medical/dental/vision, life insurance, 401(k) with match, paid vacation/holidays, global shutdown days, wellness resources/support programs, and eligibility for equity awards.