Senior Director, IT Compliance & Governance (Contractor)
4D Molecular Therapeutics
August 18, 2026
Remote friendly (United States)
United States
IT
General Summary:
- Oversees 4DMT’s GxP Compliance Audit and Supplier Quality Management Programs; contributes to Quality Assurance and Compliance mission and strategic plan.
Major Duties & Responsibilities:
- Operationally manage GxP Compliance Audit and Supplier Quality Management Programs.
- Audit Program:
- Coordinate and manage clinical site, internal, and vendor audits (schedule, plan, track, document, and close).
- Review audit deliverables for accuracy, consistency with standards, and GxP compliance.
- Track/facilitate timely closure of Audit Confirmation Letters, Audit Reports, Observation Responses, and Audit Certificates.
- Ensure audit deliverables are reviewed, distributed, and archived per procedures.
- Schedule pre/post-audit meetings; coordinate auditor system access/documentation.
- Establish/update risk-based Annual Audit Schedule and ensure execution across clinical sites, internal systems/processes, and vendors/suppliers (e.g., contract manufacturers, testing labs, CROs).
- Support QA auditors with CAPAs and Effectiveness Checks (ECs) for significant observations.
- Monitor/track/collect/archive CAPA and EC evidence as required.
- Ensure QA auditors are qualified and trained per procedures.
- Supplier Quality Management Program:
- Maintain accuracy/completeness of the Approved GxP Supplier List.
- Coordinate supplier risk assessments; identify and execute risk-based supplier evaluation/qualification requirements.
- Support compliance with the Supplier Quality Management procedure.
- General:
- Develop relationships with quality team, cross-functional partners, and vendors.
- Develop/report audit and supplier quality metrics for Quality Assurance Management Review.
- Drive continuous improvement of the Quality Management System via assigned QA process/initiatives.
Qualifications:
- Education: B.S./B.A. in science/life sciences or equivalent; advanced degree preferred.
- Experience: 8+ years in regulated biotech environment; minimum 3+ years with responsibility for providing GxP QA oversight.
- Skills/Requirements: GxP Quality Management Systems; QA audit support; quality investigation/root cause analysis; in-depth GMP/GCP knowledge; clinical quality assurance across development lifecycle; excellent oral/written communication and interpersonal skills; comfortable in fast-paced small company with minimal direction.
Travel: 5%.
Compensation:
- Hourly compensation range: $75.00–$86.00/hr.
- Oversees 4DMT’s GxP Compliance Audit and Supplier Quality Management Programs; contributes to Quality Assurance and Compliance mission and strategic plan.
Major Duties & Responsibilities:
- Operationally manage GxP Compliance Audit and Supplier Quality Management Programs.
- Audit Program:
- Coordinate and manage clinical site, internal, and vendor audits (schedule, plan, track, document, and close).
- Review audit deliverables for accuracy, consistency with standards, and GxP compliance.
- Track/facilitate timely closure of Audit Confirmation Letters, Audit Reports, Observation Responses, and Audit Certificates.
- Ensure audit deliverables are reviewed, distributed, and archived per procedures.
- Schedule pre/post-audit meetings; coordinate auditor system access/documentation.
- Establish/update risk-based Annual Audit Schedule and ensure execution across clinical sites, internal systems/processes, and vendors/suppliers (e.g., contract manufacturers, testing labs, CROs).
- Support QA auditors with CAPAs and Effectiveness Checks (ECs) for significant observations.
- Monitor/track/collect/archive CAPA and EC evidence as required.
- Ensure QA auditors are qualified and trained per procedures.
- Supplier Quality Management Program:
- Maintain accuracy/completeness of the Approved GxP Supplier List.
- Coordinate supplier risk assessments; identify and execute risk-based supplier evaluation/qualification requirements.
- Support compliance with the Supplier Quality Management procedure.
- General:
- Develop relationships with quality team, cross-functional partners, and vendors.
- Develop/report audit and supplier quality metrics for Quality Assurance Management Review.
- Drive continuous improvement of the Quality Management System via assigned QA process/initiatives.
Qualifications:
- Education: B.S./B.A. in science/life sciences or equivalent; advanced degree preferred.
- Experience: 8+ years in regulated biotech environment; minimum 3+ years with responsibility for providing GxP QA oversight.
- Skills/Requirements: GxP Quality Management Systems; QA audit support; quality investigation/root cause analysis; in-depth GMP/GCP knowledge; clinical quality assurance across development lifecycle; excellent oral/written communication and interpersonal skills; comfortable in fast-paced small company with minimal direction.
Travel: 5%.
Compensation:
- Hourly compensation range: $75.00–$86.00/hr.