Senior Manager, Audit and Supplier Management – Contract

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

📋 Description

• Report to the Director of Quality Systems and support 4DMT’s Quality Assurance and Compliance mission, objectives, and strategic initiatives.

• Oversee the operational management of the GxP Compliance Audit Program and the Supplier Quality Management Program.

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

• Review audit deliverables for accuracy, adherence to 4DMT standards, and GxP compliance.

• Track and facilitate the confirmation of audits, reports, responses to observations, and certificates.

• Ensure that audit deliverables are reviewed, distributed, and archived in accordance with established procedures.

• Schedule pre- and post-audit meetings, ensuring that auditors have the necessary system access and documentation.

• Develop and update a risk-based Annual Audit Schedule and coordinate its execution.

• Collaborate on Corrective and Preventive Actions (CAPAs) and Effectiveness Checks for significant audit findings, and collect/archive evidence of completion.

• Ensure that QA Auditors are qualified and adequately trained.

• Maintain the Approved GxP Supplier List and manage the identification, assessment, qualification, and reassessment of suppliers.

• Conduct supplier risk assessments and ensure that risk-based evaluation and qualification requirements are met.

• Create audit and supplier quality metrics for reporting in Quality Assurance Management Review.

• Support the ongoing improvement of the Quality Management System and QA processes.

⛳️ Requirements

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

• Over 8 years of experience in a regulated environment such as Regulatory Affairs, Quality Assurance, Pharmacovigilance, or Clinical Development/Operations in biotech or a comparable industry.

• At least 3 years in a position that includes responsibility for GxP QA oversight.

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

• Familiarity with quality investigation and root cause analysis methodologies.

• Comprehensive understanding of GMP and GCP requirements pertaining to investigational products.

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

• Exceptional oral and written communication skills.

• Strong interpersonal skills and a collaborative mindset.

• Ability to thrive in a fast-paced small-company environment with minimal supervision and adapt workload as priorities evolve.

• Sedentary work physical requirements and standard office/administrative working conditions.

🏝️ Benefits

• Hourly compensation range of $75.00–$86.00/hr.

• 5% travel requirement.