Senior Specialist, Quality Training (Contract) at 4D Molecular Therapeutics
United States
$0.055k - $0.064k
<div class="content-intro"><p><strong><em>Attention recruitment agencies:</em></strong><em> 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.</em></p> <p> </p> <p>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</p></div><p><span data-contrast="auto">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. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="auto">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. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></p> <p><span data-contrast="auto">Reporting to the Associate Director of Quality Training. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></p> <p><strong><span data-contrast="auto">MAJOR DUTIES & RESPONSIBILITIES:</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></p> <ul> <li><span data-contrast="auto">Support the training governance framework, policies, and standards for the GxP training program</span><span data-ccp-props="{"201341983":0,"335559685":900,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="auto">Assist with Learning Management System administration with related processes to IT LMS system administrators </span><span data-ccp-props="{"201341983":0,"335559685":900,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="auto">Serve as the LMS business administrator to create, edit, and retire training items, curricula, and training assignments in GxP functional areas</span><span data-ccp-props="{"201341983":0,"335559685":900,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="auto">Coordinate and aid with regularly scheduled GxP / Quality onboarding training for new hires </span><span data-ccp-props="{"201341983":0,"335559685":900,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="auto">Manage, track, and prioritize training requests from the business for curricula and course management, training assignments, and reporting </span><span data-ccp-props="{"201341983":0,"335559685":900,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="auto">Partner and support functional leaders across the business with enterprise-wide, role-based training requirements and implement within the LMS </span><span data-ccp-props="{"201341983":0,"335559685":900,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="auto">Gather and provide training data to integrate training metrics for department communications or Quality Management Review process </span><span data-ccp-props="{"201341983":0,"335559685":900,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="auto">Support the records management of training and qualification records (physical and electronic) </span><span data-ccp-props="{"201341983":0,"335559685":900,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></li> <li><span data-contrast="auto">Support audits/inspections of the training program and provide assistance during regulatory inspections </span><span data-ccp-props="{"201341983":0,"335559685":900,"335559739":0,"335559740":240,"469777462":[2970],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <p><strong><span data-contrast="auto">QUALIFICATIONS: </span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p> <p><span data-contrast="auto">Education: </span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">B.S. or B.A. preferred</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <p><span data-contrast="auto">Experience:</span><span data-ccp-props="{"134233117":true,"134233118":true,"134233279":true,"201341983":0,"335559740":240}"> </span></p> <ul> <li><span data-contrast="auto">3-5 years of progressive experience in biotech/pharmaceutical industry</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">2+ years supporting GxP training programs, LMS management, or Quality Systems</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">General knowledge of adult learning principles, instructional design, and project management </span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">General understanding of global GxP regulations (FDA, EMA, ICH, etc)</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Knowledge in learning management systems and quality systems</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Business knowledge of Clinical Research, Development, and Manufacturing in the pharmaceutical industry</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Experience working within one or more GxP disciplines: </span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">GMP (Good Manufacturing Practice)</span><span data-ccp-props="{"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">GCP (Good Clinical Practice)</span><span data-ccp-props="{"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">GLP (Good Laboratory Practice)</span><span data-ccp-props="{"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">GDP (Good Distribution Practice)</span><span data-ccp-props="{"201341983":0,"335559740":240}"> </span></li> </ul> <p><span data-contrast="auto">Other Qualifications/Skills:</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li><span data-contrast="auto">Knowledge of LMS administration and processing </span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Excellent written and verbal communication skills </span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Strong organizational skills </span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Proficiency in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint,), Adobe Acrobat, survey tools. </span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Knowledge of good documentation principles </span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <p><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"></span></p> <p class="pf0"><span class="cf0">Physical Requirements and Working Conditions:</span></p> <ul> <li class="pf1"><span class="cf0">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.</span></li> <li class="pf1"><span class="cf0">Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).</span></li> </ul> <p><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"></span></p> <p>Hourly compensation range: $55.00 - 64.00</p><div class="content-conclusion"><div>4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.</div> <div> </div> <div>Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities</div></div>
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