Senior Specialist, Quality Training

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $55 - $64 / hour

⏳ Contract/Temporary

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 Description

• Support the training governance framework, policies, and standards for the GxP training program • Assist with Learning Management System administration and related processes with 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 for curricula and course management, training assignments, and reporting • Partner with functional leaders across the business on enterprise-wide, role-based training requirements and implement them within the LMS • Gather and provide training data for department communications or the Quality Management Review process • Support records management of physical and electronic training and qualification records • Support audits and inspections of the training program and provide assistance during regulatory inspections • Support governance, regulatory compliance, LMS, and training performance outcomes across the organization • Support the Quality Training Lead with execution of GxP learning strategies and regulatory training compliance • Report to the Associate Director of Quality Training

🎯 Requirements

• 3–5 years of progressive experience in the 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, including FDA, EMA, and ICH • Knowledge of 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, GCP, GLP, or GDP • 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, and survey tools • Knowledge of good documentation principles • Sedentary-work physical requirements and typical office/administrative working conditions

🏖️ Benefits

• Hourly compensation of $55.00 - $64.00 • Remote work arrangement • Equal employment opportunity protections • Protected Veterans/Individuals with Disabilities protections