Sr. Director, Quality Assurance

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

Overview

Sr. Director, Quality Assurance
Be Part of One Team, One Purpose.
At Emmes Group, we're shaping the future of clinical research-where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we've led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.
Through our two business units-Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions -we are modernizing clinical trials and accelerating the development of life-changing therapies.
We believe that every clinical breakthrough starts with people-people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.
The Senior Director, Quality Assurance is a key member of the Quality Leadership Team providing quality assurance oversight for global clinical trials while supporting the broader Quality Management System (QMS) across the organization. This role directs the strategy, planning, and execution of the Clinical QA program and leads a global team of QA professionals. This role supports the VP, Quality & Compliance with inspection readiness, enterprise-level quality governance, metrics and trending, and QMS continuous improvement.

Responsibilities

• Provide ongoing leadership and oversight to sustain, optimize, and continuously enhance the global risk based Clinical Quality Assurance strategy to ensure compliance with international regulatory requirements (e.g., FDA, EMA, ICH GCP) and corporate standards.
• Lead the design and execution of the internal audit program ensuring QMS compliance and remediation of impacted groups
• Provide strategic leadership and oversight of the customer audit program, ensuring sustained audit readiness, effective hosting of qualification audits, and timely and accurate responses to questionnaires
• Lead and manage a global team of QA professionals, providing guidance, mentorship, and performance management.
• Champion the organization's inspection readiness program.
• Support the VP, Quality & Compliance in the preparation for, hosting of, and response to regulatory agency inspections.
• Review and approve audit reports, quality metrics, and CAPAs (Corrective and Preventive Actions) to ensure timely and effective resolution of quality incidents.
• Oversee QA responsibilities within the service providers management program.
• Foster a culture of quality, integrity, and continuous improvement within the organization.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

• Bachelor's Degree Life Sciences, Pharmacy, Nursing, or a related field. Required
• Master's Degree Life Sciences, Pharmacy, Nursing, or a related field. Preferred
• 12+ years of experience within the pharmaceutical, biotechnology, or CRO industry. Required
• 7+ years experience in a Clinical Quality Assurance related role Required
• 5+ years direct people management experience, including leading global teams
• Certified Quality Auditor, Certified Clinical Research Professional, Registered Quality Assurance Professional, or equivalent certification preferred.
• Excellent verbal and written communication skills. High
• Strong understanding of quality risk management in the clinical research arena. High
• Excellent interpersonal and communication skills, with the ability to build relationships with stakeholders at all levels. High
• Demonstrated ability to lead and develop a high performing team. High
• Proficiency in using eQMS tools and other related software. High
• Strong analytical skills with the ability to interpret data and make data driven decisions High

Why work at Emmes?

If you're looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.