Senior Director, IT Compliance & Governance (Contractor

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DMT 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

This position reports to the Director, Quality Systems and contributes to the development, implementation, and successful execution of 4

DMT’s Quality Assurance and Compliance mission, objectives, and strategic plan by overseeing 4

DMT’s GxP Compliance Audit and Supplier Quality Management Programs.

The Sr. Manager, Audit and Supplier Management, will be responsible for the operational management of 4

DMT’s GxP Compliance Audit and Supplier Quality Management Programs, ensuring audits are managed and documented and Suppliers assessed and qualified according to 4

DMT procedures. Specific responsibilities include:

• Audit Program:
  • Coordinate and manage clinical site, internal, and vendor audits by working with Quality Assurance,
    
    Functional Area
    
    Management, and Contract auditors to facilitate scheduling, planning, tracking, documentation, and closure of audits
  • Perform detailed review of audit deliverables to ensure accuracy, consistency with 4
    
    DMT standards, and compliance with GxP regulations.
  • Track and facilitate timely and compliant finalization of key Audit deliverables such as Audit Confirmation Letters, Audit Reports, Audit Observation Responses, and Audit Certificates by responsible parties
  • Ensure audit deliverables are reviewed, distributed, and archived in alignment with 4
    
    DMT procedural requirements.
  • Schedule pre/post-audit meetings with auditors and key stakeholders
  • Collaborate with relevant 4
    
    DMT team members to ensure auditors have required system access / documentation in support of audits.
  • Work with Quality Assurance Management to establish and periodically update risk-based Annual Audit Schedule.
  • Coordinate with stakeholders to ensure the Annual Audit Schedule is executed, including the scheduling of GxP audits for clinical sites, internal 4
    
    DMT systems / processes, and vendors / suppliers such as contract manufacturers, testing laboratories, and clinical research organizations.
  • Collaborate with QA Auditors to ensure responses to significant audit observations include adequate Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs), as applicable.
  • Monitor, track, and collect/archive evidence of completion of Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs) for significant audit observations, when required.
  • Ensure QA Auditors are qualified and trained per 4
    
    DMT procedures.
• Supplier Quality Management Program:
  • Ensure 4
    
    DMT’s Approved GxP Supplier List is accurate and complete by working with stakeholders to support timely identification, assessment, qualification, and periodic re-assessment of GxP Suppliers
  • Coordinate and manage the completion of supplier risk assessments
  • Ensure appropriate supplier evaluation / qualification requirements are identified based on risk, communicated as appropriate, and executed
  • Support compliance with 4
    
    DMT’s Supplier Quality Management procedure
  • Develop excellent working relationships with the quality team, cross-functional business partners, vendors, and other functions
  • Develop and report meaningful audit and supplier quality metrics for Quality Assurance Management Review reporting
  • Support a quality-focused work environment that fosters learning,…