Quality Manager

Parexel; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a senior clinical research professional to strengthen quality and risk management across multiple projects. You will lead CAPA development, root-cause analyses, and ensure ICH-GCP compliance while mentoring teams and contributing to SOP updates.

Ideal candidates have 8–12 years in clinical research, fluency in English, and a life sciences background, with advanced degrees preferred. This role emphasizes leadership and cross-project accountability.

Qualifications

• 8-12 years’ experience in clinical research.
• Demonstrated experience in Quality or Risk Management activities.
• Expertise in CAPA development.
• Proven leadership in mentoring teams and managing complex, multi-project accounts.
• Comprehensive mastery of ICH-GCP principles and their strategic application.
• Fluency in written and oral English; additional languages an asset.
• Support of functional SOP updates and participation in general Quality-related initiatives
• Bachelor’s Degree required preferably in life sciences or health-related discipline or equivalent experience.
• Advanced degree (master’s degree) strongly preferred.

Responsibilities

• Oversee quality and risk management activities across clinical projects.
• Lead CAPA development and root-cause analyses.
• Mentor teams and manage multi-project accounts.
• Ensure compliance with ICH-GCP principles and SOPs.
• Contribute to quality initiatives and SOP updates.

Skills

Quality Management

Risk Management

CAPA Development

Root Cause Analysis

Leadership mentoring

ICH-GCP knowledge

English Fluency

Education

Bachelor's Degree in Life Sciences

Master’s Degree preferred

Job description

When our values align, there’s no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

• Job Purpose:

• 8- 12 years’ experience in clinical research

• Demonstrated experience in Quality or Risk Management activities

• Expertise in root cause methodologies and CAPA development

• Proven leadership in mentoring teams and managing complex, multi-project accounts

• Comprehensive mastery of ICH-GCP principles and their strategic application.

• Fluency in written and oral English; additional languages an asset.

• Support of functional SOP updates and participation in general Quality-related initiatives

• Bachelor’s Degree required preferably in life sciences or health-related discipline or equivalent experience.

• Advanced degree (master’s degree) in a science, technology or industry-related discipline strongly preferred.