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

Worldwide Clinical Trials - USA; North Carolina; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading global clinical research organization is seeking a Quality Assurance professional to uphold high standards. The role involves mentoring, conducting audits, and ensuring compliance with regulatory requirements. Ideal candidates will have extensive GCP experience and strong leadership skills.

Qualifications

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

Responsibilities

• Champion Worldwide’s Quality Management System (QMS).
• Mentor a team of Quality professionals.
• Perform QA audits for vendors and internal processes.

Skills

Leadership

Communication

Decision-making

Education

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

Job description

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, a global team of over 3,500 experts, bright thinkers, dreamers, and doers, changing the way the world experiences CROs for the better.

Our mission is to work with passion and purpose every day to improve lives. We seek others who value this pursuit.

Why Worldwide

We believe everyone plays an important role in making a difference for patients and caregivers. From our accessible leaders to our supportive teams, we are committed to enabling professionals from all backgrounds to succeed. We prioritize diversity and inclusion, fostering a collaborative and creative environment. Our workplace is one where people thrive by being themselves and are inspired to do their best work every day. Join us!

What the Quality Assurance Department does at Worldwide

The QA department sets high standards for quality, committed to exceeding sponsor, participant, and regulatory requirements. Our QA culture empowers staff to deliver high-quality products and services.

What you will do

1. Champion and adhere to Worldwide’s Quality Management System (QMS).
2. Participate in crafting QA organizational goals and objectives.
3. Mentor a team of Quality professionals, ensuring timely, compliant deliverables for all audit and inspection activities.
4. Oversee, monitor, and report on internal and external QA audits, ensuring timely CAPA completion and process improvements.
5. Develop and drive continuous process improvements.
6. Contribute to the development and review of Quality Management Documents.
7. Assist in tracking and reporting Key Quality Indicators (KQI) and Quality Tolerance Limits (QTL) for the audit and inspection programs.
8. Perform QA audits for vendors, internal processes, clinical investigators, documents, and other areas as assigned.
9. Manage, plan, host, report, document, and follow up on all Worldwide sponsor audits.
10. Serve as a core member of the Global Regulatory Inspection Team for all regulatory inspections of Worldwide.
11. Support sponsor inspections related to Worldwide services.
12. Act as a Subject Matter Expert on QA processes for audits and inspections.

What you will bring to the role

• Ability to work independently with minimal supervision.
• Excellent organizational leadership skills, including effective meeting management.
• Strong decision-making capabilities.
• Effective communication and influencing skills.
• Professional, clear, and concise communication with internal and external stakeholders.
• Solid understanding of clinical research principles and processes.
• Ability to collaborate across functions to improve processes based on Quality Indicators.

Your experience

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

We love knowing that someone’s work will lead to a better life. To explore more roles, visit our careers page at Discover a world of difference at Worldwide! For more information, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer committed to diversity and inclusion. We believe that a respectful, inclusive environment fosters creativity and success. We are dedicated to hiring the best talent and providing equal opportunities regardless of race, ethnicity, religion, gender, age, disability, or other protected classes.