Remote Quality Assurance Manager - GxP & Regulatory Oversight

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

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.