Associate Director

IT Compliance

Confirmed live in the last 24 hours

4D Molecular Therapeutics

4D Molecular Therapeutics

51-200 employees

Develops gene therapy products for serious diseases


Compensation Overview

$171,000 - $225,000Annually


Oakland, CA, USA

Required Skills
Quality Assurance (QA)
  • Bachelor’s Degree in a Life Science or Computer Science
  • Certifications related to GxP, SOX & Privacy regulations, IT operations & project management strongly preferred
  • 8+ years directly managing or auditing IT operational process
  • 3+ years developing, implementing & maintaining SDLC in alignment with principles of GAMP 5
  • 3+ years of experience in a senior IT leadership position w/demonstrated ability to lead compliance & project teams within the Biotech or Pharma industry
  • Recent roles & achievements that demonstrate clear expertise delivering & maintaining compliant Accounting, QA/QC, Manufacturing, Clinical, Quality, Facilities & IT applications, segregations of duty, interfaces & processes
  • Direct involvement as IT lead for at least one FDA inspection & for multiple annual external audits of SOX IT General Control design & effectiveness, Segregation of Duties & SSAE-18 SOC Report reviews
  • Multiple lab, scientific &/or financial software implementations (SDLC/Change Mgmt) as IT lead or compliance/validation lead
  • Demonstrated understanding of project management methodology, & experience adopting industry best practices. PMP, ITIL, or other formal certification is desired
  • Strong knowledge of IT implications of cGMP, GCP & ICH guidelines, Part 11/Annex 11 for US, Canada & EU markets; SOX; & privacy regulations
  • Solid GAMP5-based SDLC/validation skills
  • Strong skills designing & auditing compliant IT operational processes including SDLC, Change, Access, Inventory, Data Protection/Backup, Service Continuity Management
  • Strong skills utilizing & administering GRC, QMS & LMS tools required
  • Skills with Veeva eTMF, ELN/LIMS, NetSuite, Coupa, ADP & SharePoint a plus
  • Ensures 4DMT IT operates in compliance to GxP, SOX & Privacy regulations & ensures compliance objectives are demonstrably met with auditable evidence on an ongoing basis.
  • Builds effective partnerships with business process owners, IT system owners, system administrators, Quality staff, internal/external auditors, inspectors & other cross-functional stakeholders to develop, implement & maintain the IT compliance program.
  • Develops, manages & maintains compliance strategy, governance, policies, processes, controls, improvements, risk assessments, compliance checks & team domain knowledge to ensure key activities are effectively & efficiently executed for 4DMT IT systems.
  • Manages IT compliance-related staff, service providers, budgets, audits, inspections & projects.
  • Conducts risk assessments of key systems, accounts, & other in scope areas & activities.
  • Acts as the primary IT contact for all related compliance audits or inspections, including those related to SOX, GxP & Privacy.
  • Provides expert consulting across 4DMT stakeholders of the IT regulatory landscape & upcoming changes, of compliance requirements & best practices & of continuous improvement.
  • Develops, socializes & reinforces responsibility matrices to ensure compliance responsibilities are clearly understood throughout 4DMT.

4D Molecular Therapeutics

4D Molecular Therapeutics


4D Molecular Therapeutics, a clinical stage biopharma company, excels in genetic medicine with a focus on curative therapies across various specialties such as ophthalmology, pulmonology, and cardiology. They leverage a unique vector discovery platform, Therapeutic Vector Evolution, which employs directed evolution to design uniquely effective vectors. This commitment to tailored therapeutic solutions and cutting-edge technology makes it an exceptional workplace for professionals passionate about pioneering in the field of genetic medicine and contributing to significant advancements in healthcare.

Company Stage


Total Funding



Emeryville, California



Growth & Insights

6 month growth


1 year growth


2 year growth