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Sr. Manager, Quality Training

4dmoleculartherapeutics · 12 days ago
$131k+
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Full-time
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Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

 

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.

To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.

In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

4DMT is hiring a Sr. Manager, Quality Training to manage 4DMT's Quality Training Program. The Sr. Manager, Quality Training will be responsible for driving user-focused strategies to ensure effective and compliant training is efficiently delivered enterprise-wide via 4DMT's Learning Management System.  

The Sr. Manager, Quality Training will be responsible for working with key stakeholders in the business to define training requirements and ensure 4DMT's training processes and LMS configuration are designed to optimally achieve these requirements. This role is also responsible for ensuring training program inspection readiness / inspection support, maintenance of training records, and coordination of periodic in-person GXP training activities. 

Reporting to the Sr. Director of QA and Compliance. This role can be in-person or hybrid.  

RESPONSIBILITIES:   

  • Management of 4DMT's Quality Training Program = 100% of the time: 
  • Define/update policies and procedures related to 4DMT’s Quality Training Program 
  • Work with functional leaders across the business to ensure enterprise-wide, role-based training requirements are defined appropriately and implemented within the LMS 
  • Provide direction/guidance on Learning Management System configuration and related processes to IT LMS system administrators 
  • Ensure LMS is configured and administered effectively to manage course deployments, tracking, and reporting  
  • Ensure LMS course assignments are accurate and appropriate through governance and partnerships with functions across 4DMT 
  • Author, coordinate, and execute regularly scheduled GxP / quality onboarding training for new hires 
  • Coordinate annual GMP and GCP refresher training for personnel supporting GMP and GCP activities respectively 
  • Participate in cross-functional project teams to refine training and on-boarding processes 
  • Manage training administration, communications, curricula endorsements, and reporting 
  • Ensure consistent implementation of LMS assessment feature best practices and standards  
  • Work with assigned areas/lines to plan and coordinate training sessions to support compliance  
  • Ensure that compliance reporting and inspection readiness support is provided to customers  
  • Track and support reporting of training compliance metrics 
  • Manage archival of training records as needed 
  • Support audits/inspections of the training program and serve as the training program Subject Matter Expert during regulatory inspections 
  • Work with interdepartmental subject matter experts at all levels of the organization to plan, develop, and coordinate execution of GXP training programs / initiatives 

QUALIFICATIONS:  

Education:  

  • B.Sc. minimum 

Experience:  

  • 5 - 8 years of experience in biotech / pharmaceutical industry, including a training-related role. 
  • Demonstrated knowledge of adult learning principles, instructional design, and project management expertise.  
  • Advanced business knowledge of Clinical Research, Development, and Manufacturing in the pharmaceutical industry.  
  • Demonstrated ability to manage multiple, highly complex projects concurrently.  
  • Prior experience in monitoring adherence to compliance-based training programs. 
  • Demonstrated ability to influence and negotiate effectively and implement large-scale change.  
  • Experience with Learning Management Systems (experience with ComplianceWire preferred) 

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 GCPs, GLPs and GMPs  

Base salary compensation ranges. Please note the base salary compensation range and actual salary offered to the final candidate depends on various factors: the candidate’s geographical location, relevant work experience, skills, and years of experience.

National range: $115,000 - $141,000

Bay Area Range: $132,000 - $155,000

 

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.
 
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Last updated on Jun 7, 2024

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