Sr. Director, Quality Assurance

Emmes; Rockville (MD); On-site; USD 180,000 - 240,000; Full time

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.

Skills

Quality Assurance

Leadership

Regulatory compliance

Auditing

Data analysis

Communication

Education

Bachelor's Degree Life Sciences

Master's Degree Life Sciences

Tools

eQMS software

Quality Management System 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?

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

CONNECT WITH US!

Find us on LinkedIn:/the-emmes-group/

Visit our website: https://www.theemmesgroup.com/

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.

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