Quality Manager (full-time, remote)

OnQ Research - A P95 company; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company as a Quality Manager, where you will develop and maintain a robust Quality Management System in compliance with GxP regulations. This role emphasizes continuous improvement and operational excellence, ensuring quality standards are met across processes. Collaborate with a dynamic, multicultural team of nearly 300 professionals, working remotely with flexible schedules. If you are passionate about quality assurance and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• 2-5 years of experience in a GxP-regulated environment.
• Proficiency in writing SOPs and process flowcharts.

Responsibilities

• Manage QMS processes ensuring compliance with standards.
• Conduct internal and third-party audits, supporting external inspections.

Skills

Problem-solving skills

Analytical skills

Communication skills

Knowledge of GCP

Experience with audits

Education

Bachelor’s or PhD in Life Sciences

Tools

Electronic document management systems

Audit management systems

Job description

Join to apply for the Quality Manager (full-time, remote) role at OnQ Research - A P95 company

Job Purpose

The Quality Manager is responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) in compliance with global and local GxP (good practices) regulatory requirements such as Good Clinical Practices (GCP), Good Epidemiology Practices (GEP), Good Pharmacovigilance Practices (GVP), International Organization for Standardization (ISO) as applicable. This role ensures adherence to quality standards across processes, continuous improvement, and operational excellence.

Position Details

• Permanent employee, Full-time
• Remote

Responsibilities

• Manage assigned QMS processes, ensuring compliance with regulatory standards;
• Write and update Written Standards (Policies, Standard Operating Procedures, Guidance, and Work Instructions);
• Lead monitoring and reporting of training compliance, identifying gaps, and ensuring corrective actions;
• Manage Quality questionnaires and due diligence activities;
• Develop and oversee the implementation and follow-up of quality and compliance metrics on deviations, corrective and preventive actions, risks and change controls, ensuring timely resolution;
• Conduct internal, site, and third-party audits, ensuring compliance and identifying areas for improvement;
• Support external audits and inspections, assisting in document preparation, hosting, and follow-up actions.

Experience and Skills

• Bachelor’s or PhD in Life Sciences;
• 2 to 5 years of experience in a GxP-regulated environment;
• Experience with quality questionnaires, due diligence management, internal and external audits;
• Proficiency in writing and implementing Written Standards, process flowcharts, and RACI matrices;
• Knowledge of training management, risk management, deviations, CAPA, change control;
• Familiarity with electronic QMS tools and systems;
• Strong analytical, problem-solving, and communication skills;
• Ability to work independently and collaboratively in a remote environment.

Why Join Us?

You will join a dynamic, multicultural team of nearly 300 colleagues across more than 20 countries, working remotely with flexibility and autonomy. We value initiative, responsibility, and a shared purpose to improve healthcare through scientific research.

Visit our website www.p-95.com to learn more and apply via our short form. For assistance, email [e-mail]. We are an Equal Opportunities Employer, committed to diversity and inclusion.