Clinical Quality Assurance Manager

Title: Clinical Quality Assurance Manager

Location: Durham United States

Job Description:

The Clinical Quality Assurance Principal plays a key role in ensuring Good Clinical Practice (GCP) compliance across clinical trials, vendors, and suppliers. This position verifies adherence to applicable Standard Operating Procedures (SOPs) and regulations, leads audits and process improvement initiatives, and provides expert guidance on clinical quality management. The role also supports regulatory authority inspections, contributes to business development activities, and mentors junior staff on quality processes and regulatory requirements.

Responsibilities

• Verify GCP compliance with applicable Standard Operating Procedures (SOPs), regulations, and internal quality standards.
• Conduct comprehensive audits of clinical trial sites, vendors, and suppliers to assess compliance and identify areas for improvement.
• Provide full support to the Quality Management System, including implementation, maintenance, and continuous enhancement of quality processes.
• Conduct external audits at clinical sites and vendor locations, including planning, execution, reporting, and follow-up on findings.
• Lead process improvement activities, including the identification, development, and implementation of corrective and preventive actions (CAPA).
• Investigate quality issues and CAPA events, and drive effective root cause analysis and sustainable remediation.
• Review clinical quality management plans and provide consultative support to clinical sites, ensuring robust quality oversight of clinical activities.
• Train and mentor junior staff on GCP regulations, quality processes, and audit methodologies to build organizational quality capabilities.
• Support regulatory authority inspections by preparing documentation, coordinating responses, and participating in inspection activities.
• Collaborate with cross-functional teams to ensure quality considerations are integrated into clinical operations and vendor management.
• Support business development activities by contributing quality and GCP expertise to proposals, client discussions, and strategic initiatives.
• Maintain accurate and timely documentation of audits, CAPA activities, and quality management activities in accordance with SOPs.

Essential Skills

• Strong, current knowledge of Good Clinical Practice (GCP) regulations and guidelines.
• At least 6 years of experience conducting GCP clinical site audits.
• Experience supporting or participating in regulatory authority inspections.
• Experience working with Quality Systems within a Contract Research Organization (CRO) environment.
• Demonstrated expertise in Clinical Quality Assurance, including GCP compliance and audit practices.
• Proven experience with CAPA investigations and process improvement initiatives.
• Strong understanding of regulatory compliance requirements for clinical trials.
• Excellent written and verbal communication skills, including the ability to prepare clear audit reports and quality documentation.
• Proficiency in Microsoft Office applications (e.g., Word, Excel, PowerPoint).

Additional Skills & Qualifications

• Experience conducting audits of clinical sites, vendors, and suppliers in diverse geographic regions.
• Ability to provide consultative support on clinical quality management plans to internal teams and clinical sites.
• Skill in training and mentoring junior staff on regulations, quality processes, and audit techniques.
• Ability to work independently in a remote setting while managing multiple audits and quality initiatives.
• Strong organizational and time-management skills, with the ability to prioritize tasks in a dynamic environment.
• Comfort working closely with senior quality leadership and contributing to strategic quality and business development discussions.

Work Environment

This role operates in a fully remote work environment, allowing you to perform most responsibilities from your home office while collaborating virtually with global teams. The position requires up to 25% travel, including local, domestic, and international trips to conduct audits at clinical sites and vendor locations and to support inspections or key quality activities. The organization promotes a culture of growth and internal advancement, offering opportunities to develop your career and take on increasing responsibilities, including close partnership with senior quality leadership. Standard business technology such as Microsoft Office is used extensively for documentation, reporting, and communication.

Job Type & Location

This is a Permanent position based out of Durham, NC.

Pay and Benefits

The pay range for this position is $120000.00 - $150000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Company Benefits Company Benefits Company Benefits

Workplace Type

This is a fully remote position.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.