Full-Time

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

Biotechnology

Compensation Overview

$171,000 - $225,000Annually

Senior

Oakland, CA, USA

Required Skills
Management
Quality Assurance (QA)
Coupa
Requirements
  • 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
Responsibilities
  • 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

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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

IPO

Total Funding

$595M

Headquarters

Emeryville, California

Founded

2013

Growth & Insights
Headcount

6 month growth

18%

1 year growth

20%

2 year growth

38%