Global QA Director: Strategy, Compliance & Audit

Emmes

Rockville (MD)

On-site

USD 180,000 - 240,000

Full time

3 days ago

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Benefits offered by this job

Work From Home Anywhere in the US

401k Retirement Plan

Tuition Reimbursement

Flexible Approved Time Off

Maternal/Paternal Leave

Casual Dress Code & Work Environment

Job summary

Emmes Group, a premier clinical research organization, seeks a Senior Director, Quality Assurance to lead the global QA program and support the VP of Quality & Compliance. You will guide strategy, audits, and continuous improvement across worldwide trials, ensuring regulatory readiness and strong QMS governance.

You will manage a global QA team, drive inspection readiness, and partner with stakeholders to uphold quality and safety in all trials.

Qualifications

Bachelor's degree in a life sciences field is required.
12+ years in pharmaceutical/biotech/CRO with 7+ years in QA.
5+ years leading global teams.

Responsibilities

Provide ongoing leadership to sustain and enhance global Clinical Quality Assurance strategy.
Lead internal audit program design and execution and remediation of gaps.
Oversee customer audit program, hosting qualifications and timely responses to questionnaires.
Manage a global QA team with mentorship and performance management.
Champion inspection readiness and enterprise-level quality governance.
Support regulatory inspections and agency responses.
Review audit reports, metrics, and CAPAs for timely resolution.
Oversee QA in vendor management programs.
Foster a culture of quality, integrity, and continuous improvement.