Quality Assurance Manager - Government Operations

Overview

Quality Assurance Manager - Government 

Location: Remote, US - Northern Virginia, Maryland, DC

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 Manager Quality Assurance (QA) oversees aspects of the quality program at Emmes and manages staff within the QA Department. The Manager works with QA, company, and project leadership to ensure adherence to applicable regulations, industry standards, and project requirements.

Responsibilities

• Manages a component of Emmes' Quality Management System (e.g., internal auditing program, document control, CAPA program, etc.)
• May supervise QA Department staff.
• Serves as the primary government quality point of contact and collaborator.
• Reviews and approves audit reports.
• Creates internal audit schedule.
• Leads incidents, CAPAs, client audits, questionnaires, and follow-up.
• Conducts routine and for-cause audits (e.g., project, internal, vendor) as needed. Supports audits and inspections, maintains readiness tools.
• Analyzes trends and recommends continuous improvement. 
• Drafts QA policies and procedures.
• Contributes to organization process improvement. Develops processes for technology adoption and regulatory compliance.
• Prepares Quality Management reports for QA management and internal leaders.
• Reviews and approves corporate SOPs as needed. Monitors deliverables against plans and SOPs. 
• Provides ongoing guidance on project adherence.
• Provides corporate training as needed.
• Communicate quality or compliance issues to QA and organization management.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

• Bachelor's Degree Life Sciences or a related scientific field Required
• Quality Certifications e.g., CQA, RAC, RQAP, Six Sigma Preferred
• 7-9 years working in a regulated environment (e.g., GXP, ISO) Required
• Management Experience Required
• Ability to prioritize critical tasks and provide a high level of responsiveness and timely service on a day to day basis as well as balance the unexpected needs of the company as they arise High
• Experience interacting with people at all levels of the organization leveraging negotiation and influence skills High
• Demonstrated organizational skills, high attention to detail, and ability to multi task High
• Strong written and verbal communication as well as problem solving skills High
• Microsoft Office proficiency High

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.

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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