Quality Assurance Manager - Government Operations

Emmes Group; Oregon; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Emmes Group, a leader in clinical research support, seeks a Quality Assurance Manager - Government to oversee the quality program and ensure regulatory compliance across projects. The role is remote, supporting US government-related studies, and collaborates with QA and project leadership.

You will manage audits, CAPA, document control, and SOP reviews, lead client audits and regulatory inspections, and mentor QA staff while driving process improvements and timely reporting.

Qualifications

• Bachelor’s Degree in Life Sciences or a related field is required.
• Quality Certifications such as CQA, RAC, RQAP, or Six Sigma preferred.
• 7–9 years in a regulated environment (GXP, ISO) required.
• Management experience is required.
• Strong prioritization, responsiveness, and multitasking abilities.
• Strong written and verbal communication and problem solving skills.
• High proficiency with Microsoft Office.

Responsibilities

• Oversee components of the Quality Management System (e.g., audits, document control, CAPA).
• May supervise QA staff.
• Review and approve audit reports.
• Lead internal audits and regulatory inspections.
• Draft QA policies and procedures.
• Prepare quality management reports for QA leadership.
• Communicate quality or compliance issues to management.
• Ensure compliance with policies and standards.

Skills

Quality leadership

Regulatory compliance

People management

Communication skills

Project prioritization & multitasking

Education

Bachelor's Degree Life Sciences or related field

Tools

Microsoft Office proficiency

Job description

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 HighDemonstrated organizational skills, high attention to detail, and ability to multi task HighStrong 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:

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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