Senior Director, IT Compliance – Governance

This is a fully remote position, open to applicants in California.

📋 Description

• Report directly to the Director of Quality Systems.

• Supervise 4DMT’s GxP Compliance Audit and Supplier Quality Management Programs.

• Organize and manage audits for clinical sites, internal processes, and vendors, including scheduling, planning, tracking, documentation, and closure.

• Evaluate audit deliverables for accuracy, consistency with 4DMT standards, and adherence to GxP compliance.

• Monitor and facilitate the completion of audit confirmation letters, reports, responses to observations, and certificates.

• Ensure that audit deliverables are reviewed, distributed, and archived according to established procedures.

• Arrange pre- and post-audit meetings and coordinate auditor access to systems and documentation.

• Create and update a risk-based Annual Audit Schedule and oversee its execution.

• Assist in ensuring satisfactory CAPAs and Effectiveness Checks for significant audit findings and maintain evidence of completion.

• Confirm that QA auditors are qualified and properly trained.

• Maintain the Approved GxP Supplier List and aid in the identification, assessment, qualification, and re-evaluation of suppliers.

• Coordinate supplier risk assessments and implement risk-based evaluations and qualifications of suppliers.

• Support adherence to the Supplier Quality Management procedures.

• Foster relationships with quality teams, cross-functional partners, vendors, and other departments.

• Develop and report metrics related to audits and supplier quality for the Quality Assurance Management Review.

• Promote continuous improvement initiatives within the Quality Management System and QA processes.

⛳️ Requirements

• Bachelor’s degree in a science or related life science field, or equivalent; advanced scientific degree is preferred.

• Over 8 years of experience in a regulated environment such as Regulatory, Quality, Pharmacovigilance, or Clinical Development/Operations within the Biotech sector or a comparable industry.

• At least 3 years of experience in a role that includes responsibility for GxP QA oversight.

• Demonstrated experience with GxP Quality Management Systems and QA audit support.

• Knowledgeable in quality investigation and root cause analysis techniques.

• Comprehensive understanding of GMP and GCP requirements for investigational products.

• Extensive hands-on experience with clinical quality assurance throughout the clinical development lifecycle.

• Exceptional oral and written communication skills.

• Strong interpersonal skills and a collaborative mindset.

• Capability to thrive in a fast-paced small company environment with minimal supervision and adapt workload to shifting priorities.

• Willingness to travel up to 5%.

• Ability to perform sedentary work and function in typical office or administrative settings.

🏝️ Benefits

• Equal employment opportunities.

• 5% travel requirement.

• Sedentary/typical office working conditions.