Clinical Quality Assurance Principal

Clinical Quality Assurance Principal Location: Fully Remote (U.S.) Travel: Up to 25% (local, domestic, and international) About the Opportunity We are seeking an experienced Clinical Quality Assurance Principal to join a growing clinical quality organization. This is a high-impact role supporting clinical research quality and compliance initiatives across multiple studies, sites, and vendors. The ideal candidate will bring deep expertise in Good Clinical Practice (GCP), auditing, regulatory compliance, and quality systems within a CRO or clinical research environment. This position offers the opportunity to work closely with executive leadership, influence quality strategy, drive continuous improvement initiatives, and serve as a trusted quality advisor across the organization. Key Responsibilities Ensure compliance with applicable GCP regulations, company Standard Operating Procedures (SOPs), and industry requirements. Conduct and lead audits of clinical investigator sites, vendors, suppliers, and internal processes. Support and maintain the Quality Management System (QMS). Perform external audits at clinical and vendor locations. Lead quality investigations, root cause analyses, and Corrective and Preventive Action (CAPA) activities. Review clinical quality management plans and provide consultative support to operational teams and clinical sites. Mentor and train junior staff on quality processes, GCP regulations, and audit readiness. Support regulatory authority inspections and inspection preparation activities. Partner with cross-functional teams to drive process improvements and quality excellence. Contribute to business development initiatives and quality-related client activities as needed. Required Qualifications Minimum of 6 years of experience conducting GCP clinical site audits . Strong working knowledge of current GCP regulations and regulatory requirements. Demonstrated experience in Clinical Quality Assurance within clinical research environments. Experience supporting or participating in regulatory authority inspections. Strong understanding of Quality Management Systems (QMS), preferably within a CRO setting. Proven experience leading CAPA investigations and process improvement initiatives. Excellent written, verbal, and interpersonal communication skills. Proficiency with Microsoft Office applications. Ability to travel up to 25% as required. Job Type & Location This is a Permanent position based out of Bethesda, MD. 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. Application Deadline This position is anticipated to close on Sep 23, 2026. 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. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.