Global QA Director - Inspection Readiness (Remote)

The Emmes Company, LLC; Rockville (MD); Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Flexible Approved Time Off

Tuition Reimbursement

401k Retirement Plan

Work From Home Anywhere in the US

Maternal/Paternal Leave

Casual Dress Code & Work Environment

Job summary

The Emmes Group aims to hire a Sr. Director, Quality Assurance to lead global clinical QA strategy and a worldwide QA team. This role reports to the VP, Quality & Compliance and drives inspection readiness, metrics, CAPA management, and QMS improvement across the organization.

Qualifications include 12+ years in pharma/biotech/CRO and 7+ years in a clinical QA leadership role, with strong risk management and communication skills. Position offers remote work flexibility for US-based work.

Qualifications

• 12+ years in pharma/biotech/CRO
• 7+ years in Clinical QA leadership
• 5+ years managing global teams
• Certified QA credentials preferred
• Strong written and verbal communication
• Proficiency with quality risk management in clinical research

Responsibilities

• Sustain and enhance global Clinical QA strategy with regulatory alignment
• Lead design and execution of internal QA audits and remediation
• Oversee customer audit program and audit readiness
• Manage and mentor a global QA team
• Support inspection readiness and regulatory inspections
• Review audit reports, metrics and CAPAs for timely closure
• Oversee QA within provider management programs
• Foster culture of quality and continuous improvement

Skills

Leadership

Quality risk management

Audit oversight

eQMS tools

Communication

Team development

Education

Bachelor's Degree Life Sciences, Pharmacy, Nursing, or a related field

Master's Degree Life Sciences, Pharmacy, Nursing, or a related field

Tools

eQMS tools

Job description

The Emmes Group aims to hire a Sr. Director, Quality Assurance to lead global clinical QA strategy and a worldwide QA team. This role reports to the VP, Quality & Compliance and drives inspection readiness, metrics, CAPA management, and QMS improvement across the organization.

Qualifications include 12+ years in pharma/biotech/CRO and 7+ years in a clinical QA leadership role, with strong risk management and communication skills. Position offers remote work flexibility for US-based work.