Sr. Manager, Audit Program

Attention recruitment agencies: 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.

 

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.  

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

GENERAL SUMMARY

This position reports to the Senior Director, GCP Compliance and Quality Systems and contributes to the development, implementation, and successful execution of 4DMT’s Quality Assurance and Compliance mission, objectives, and strategic plan by overseeing 4DMT’s GxP Compliance Audit Program.

 

MAJOR DUTIES & RESPONSIBILITIES:

The Sr. Manager, Audit Program, will be responsible for the operational management of 4DMT’s GxP Compliance Audit program, ensuring audits are managed and documented according to 4DMT procedures. Specific responsibilities include:

• 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 4DMT 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 4DMT procedural requirements.
• Schedule pre/post-audit meetings with auditors and key stakeholders
• Collaborate with relevant 4DMT 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 4DMT 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.
• Develop excellent working relationships with the cross-functional quality team, GxP business partners, vendors, and other functions
• Develop and report meaningful audit metrics for Clinical Quality Assurance Management Review reporting
• Ensure QA Auditors are qualified and trained per 4DMT procedures
• Support a quality-focused work environment in Clinical that fosters learning, respect, open communication, collaboration, integration, and teamwork:
• Drive the development and continuous improvement of the Clinical Quality Management System through the development / refinement of Clinical QA processes / initiatives as assigned

 

QUALIFICATIONS: 

Education: 

• B.S./B.A. in a science or related life science field or equivalent; advanced scientific degree preferred.

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