Senior Specialist, Quality Training (Contract)
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery
4DMT is hiring a Sr. Specialist, Quality Training (Contract), to support 4DMT's Quality Training Program. The Sr. Specialist, Quality Training, will be responsible for supporting the governance, regulatory compliance, learning management system, and training performance outcomes across the organization. The Sr. Specialist, Quality Training, will support the Quality Training Lead with the execution of GxP learning strategies and regulatory training compliance.
The Sr. Specialist, Quality Training, will be responsible for supporting the business to ensure training requirements are followed and ensure compliance with 4DMT's training processes and LMS configuration. This role is also responsible for supporting training program inspection readiness / preparation activities, maintenance of training records, and coordination of periodic in-person GXP training activities.
Reporting to the Associate Director of Quality Training.
MAJOR DUTIES & RESPONSIBILITIES:
- Support the training governance framework, policies, and standards for the GxP training program
- Assist with Learning Management System administration with related processes to IT LMS system administrators
- Serve as the LMS business administrator to create, edit, and retire training items, curricula, and training assignments in GxP functional areas
- Coordinate and aid with regularly scheduled GxP / Quality onboarding training for new hires
- Manage, track, and prioritize training requests from the business for curricula and course management, training assignments, and reporting
- Partner and support functional leaders across the business with enterprise-wide, role-based training requirements and implement within the LMS
- Gather and provide training data to integrate training metrics for department communications or Quality Management Review process
- Support the records management of training and qualification records (physical and electronic)
- Support audits/inspections of the training program and provide assistance during regulatory inspections
QUALIFICATIONS:
Education:
- B.S. or B.A. preferred
Experience:
- 3-5 years of progressive experience in biotech/pharmaceutical industry
- 2+ years supporting GxP training programs, LMS management, or Quality Systems
- General knowledge of adult learning principles, instructional design, and project management
- General understanding of global GxP regulations (FDA, EMA, ICH, etc)
- Knowledge in learning management systems and quality systems
- Business knowledge of Clinical Research, Development, and Manufacturing in the pharmaceutical industry
- Experience working within one or more GxP disciplines:
- GMP (Good Manufacturing Practice)
- GCP (Good Clinical Practice)
- GLP (Good Laboratory Practice)
- GDP (Good Distribution Practice)
Other Qualifications/Skills:
- Knowledge of LMS administration and processing
- Excellent written and verbal communication skills
- Strong organizational skills
- Proficiency in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint,), Adobe Acrobat, survey tools.
- Knowledge of good documentation principles
Physical Requirements and Working Conditions:
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Hourly compensation range: $55.00 - 64.00