Associate Director, QA Audits & Inspections Program - US - Remote

Worldwide Clinical Trials - USA; North Carolina; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking an Associate Director for their QA Audits & Inspections Program. This remote role involves championing a Quality Management System, mentoring QA professionals, and overseeing audits to ensure compliance with regulatory standards. The ideal candidate will have a strong background in clinical research and GCP processes, coupled with excellent communication and leadership skills. Join a dynamic team committed to improving lives through innovation and quality in clinical trials. This is a unique opportunity to make a significant impact in a supportive and diverse environment.

Qualifications

• 8+ years of GCP experience or equivalent.
• Extensive experience conducting GCP QA audits.

Responsibilities

• Champion and adhere to Worldwide’s Quality Management System (QMS).
• Oversee and report on internal and external QA audits.

Skills

Organizational Leadership

Communication Skills

Clinical Research Principles

GCP Processes

Decision-Making

Education

Bachelor’s degree in nursing, biological, physical, health, pharmacy, or related science

Job description

Associate Director, QA Audits & Inspections Program - US - Remote

Employer: Worldwide Clinical Trials - USA
Location: Virtual, North Carolina, United States
Salary: Competitive
Start date: 7 May 2025
Closing date: 8 May 2025

Who we are
We’re a global, midsize CRO committed to innovation and quality in the pursuit of cures for persistent diseases. With over 3,500 experts, we aim to change the way the world experiences CROs, working passionately to improve lives.

Why Worldwide
We value diversity and inclusion, fostering a supportive environment where professionals from all backgrounds succeed. Our culture promotes collaboration, creativity, and authenticity, enabling our team to thrive and do their best work.

What the Quality Assurance Department does
Our QA team sets high standards for quality, exceeding sponsor, participant, and regulatory expectations. We focus on training, empowerment, and delivering high-quality products.

What you will do

• Champion and adhere to Worldwide’s Quality Management System (QMS).
• Contribute to setting QA organizational goals and objectives.
• Mentor QA professionals, ensuring timely, compliant deliverables for all audit and inspection activities.
• Oversee and report on internal and external QA audits, ensuring CAPA completion and process improvements.
• Drive continuous process improvements and develop quality management documents.
• Track and report Key Quality Indicators (KQI) and Quality Tolerance Limits (QTL).
• Perform QA audits for vendors, internal processes, clinical investigators, and document audits.
• Manage and coordinate sponsor audits, including reporting and documentation.
• Serve on the Global Regulatory Inspection Team and support sponsor inspections.
• Provide SME expertise on QA processes for audits and inspections.

What you will bring to the role

• Ability to work independently with minimal supervision.
• Strong organizational leadership, including effective meeting management.
• Excellent decision-making and communication skills.
• Professional, clear, and concise communication both verbally and in writing.
• Deep understanding of clinical research principles and GCP processes.
• Ability to collaborate across functions to improve processes based on QA metrics.

Your experience

• Bachelor’s degree in nursing, biological, physical, health, pharmacy, or related science; 8+ years of GCP experience or equivalent.
• Extensive experience conducting GCP QA audits, including investigator, vendor, internal process, for-cause, and document audits.
• Experience with regulatory inspections (FDA, MHRA, Health Canada, EMA, etc.).
• Broad knowledge of GxP compliance, especially GCP.
• Proven ability to lead sponsor audits independently.
• Willingness to travel domestically and internationally as needed.

We are dedicated to making a difference in patients' lives. To explore more roles, visit our careers page or learn more about Worldwide at www.Worldwide.com. We are an equal opportunity employer committed to diversity and inclusion, providing a workplace where everyone can succeed and feel valued.