Associate Director, Therapeutic Area Quality Lead - Americas/EMEA - Remote

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

Job summary

A leading global CRO is seeking a Quality Assurance professional to champion quality management systems and oversee quality issues. The role requires strong communication, critical thinking, and project management skills, with a focus on regulatory compliance. Candidates should have a relevant advanced degree and significant experience in GCP and quality assurance.

Qualifications

• 5+ years of relevant GCP, GcLP, GLP, GVP, GPP experience.
• 7+ years of relevant GCP, GLP, GVP experience.

Responsibilities

• Champion the adoption of the Quality Management System (QMS).
• Provide consultancy and oversight for Quality Issues and CAPA Plans.
• Act as GCP Subject Matter Expert (SME) for project teams.

Skills

Communication

Critical Thinking

Project Management

Negotiation

Education

M.S. in a scientific or health-related field

Bachelor’s degree in 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 share this pursuit.

Why Worldwide

We believe everyone plays an important role in making a difference for patients and their caregivers. From our accessible leaders to our supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize a diverse and inclusive environment that promotes collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What Quality Assurance does at Worldwide

The QA department sets high standards for quality, committed to exceeding requirements from sponsors, study participants, and regulatory authorities. Our QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers.

What you will do

• Champion the adoption of the Quality Management System (QMS).
• Provide consultancy and oversight for Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Plans.
• Maintain up-to-date electronic filing and management for QI and CAPA documentation.
• Act as GCP Subject Matter Expert (SME), providing GCP consultancy to project teams within the assigned Therapeutic Area (TA) and functional areas.
• Perform TA and study data review and trending activities.
• Collaborate with Risk-Based Quality Management for risk assessment.
• Support Clinical Investigator Site inspections and audits as needed.
• Review QMD deviations for project teams within the SME area.
• Review and manage QA of Quality Management Documents (QMDs).
• Manage relationships with Sponsor QA counterparts, including quality agreements and metrics.
• Manage the business/operational relationship between QA and operational/TA leadership.
• Assist with Sponsor audits and regulatory inspections as needed.

What you will bring to the role

• Professional, concise, clear communication skills, both verbal and written.
• Customer-focused approach.
• Excellent critical thinking skills.
• Ability to plan, adjust, manage, and optimize resources for QA goals.
• Experience managing projects/teams of significant scope and complexity.
• Independent work ethic, initiative, and flexibility.
• Strong influencing and negotiation skills.

Your background

• M.S. or equivalent in a scientific or health-related field with 5+ years of relevant GCP, GcLP, GLP, GVP, GPP experience.
• Bachelor’s degree or equivalent in biological, physical, health, pharmacy, or related sciences with 7+ years of relevant GCP, GLP, GVP experience.
• Broad experience in quality and regulatory compliance related to GxP activities, especially GCP.
• Excellent knowledge of Quality Management Systems, ICH Guidelines, FDA regulations, European Directives, and UK Statutory Instruments relevant to GCP.
• Understanding of drug development processes.
• Experience supporting Regulatory Inspections is a plus.
• Domestic and international travel may be required (up to 15%).

We are committed to diversity and inclusion and provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, religion, gender, sexual orientation, age, disability, or other protected status.