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Quality Assurance Manager - Government Operations

Role overview

Summary

The role is for a Quality Assurance Manager at Emmes Group, overseeing the quality program and managing staff within the QA Department. This position ensures adherence to regulations and industry standards, contributing to the overall quality management and process improvement efforts within the organization.

Qualifications

  • Bachelor's Degree Life Sciences or a related scientific field.
  • 7-9 years working in a regulated environment (e.g., GXP, ISO).
  • Management Experience.
  • Strong written and verbal communication as well as problem solving skills.
  • Preferred: Quality Certifications e.g., CQA, RAC, RQAP, Six Sigma.

Responsibilities

  • Manages a component of Emmes' Quality Management System.
  • Reviews and approves audit reports.
  • Leads client audits and regulatory inspections.
  • Drafts QA policies and procedures.

Key facts

Hard skills

Other skills

  • Quality Assurance
  • Management
  • Negotiation
  • Organizational Skills
  • Detail Oriented
  • Multitasking
  • Communication
  • Problem Solving
  • Microsoft Office

About the company

Emmes logo

Emmes

  • Clinical Research (CRO)
  • Large
  • 1,001–5,000
For over 40 years, our team of 1,000+ experienced professionals have provided the full range of Contract Research Organization expertise necessary to conduct clinical research with a firm scientific basis that is fully compliant with national and international regulatory guidelines. With offices throughout the US, Europe, Canada, and India, Emmes supports the advancement of global public health and biopharmaceutical innovation through disciplined science, rigorous research, fact-based decision-making, and operational excellence. Emmes possesses knowledge across a broad range of therapeutic areas, with specializations in Vaccines and Infectious Diseases, Ophthalmology, Immunology and Neuroscience. From comprehensive support of pandemic research to groundbreaking work in cell and gene therapy across the globe, Emmes has collaborated on clinical research across a wide array of disease states in over 75 nations. As a strategic collaborator with applied talent in over 2,000 clinical trials and contributions to over 2,500 publications that advance the understanding of medicine and public health, Emmes is committed to expanding the services offered to best meet the changing needs of clients and studies. Ongoing investments in global clinical research capabilities, innovative data management platforms, biostatistics/bioinformatics expertise, and people have enabled Emmes to provide a multi-faceted approach to help you meet your research objectives. Emmes is a diverse, inclusive, innovative CRO that values integrity, agility, passion for excellence, collaborative partnerships, and intellectual curiosity.

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Job description

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.
  • Reviews and approves audit reports.
  • Created internal audit schedule.
  • Leads client audits and regulatory inspections.
  • Conducts audits (e.g., internal, vendor) as needed.
  • Drafts QA policies and procedures.
  • Contributes to organization process improvement.
  • Prepares Quality Management reports for QA management and internal leaders.
  • Reviews and approves corporate SOPs as needed.
  • 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.

#LI-Remote 

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