What are the responsibilities and job description for the Principal Clinical Quality Assurance Specialist position at Experis?
Our client, a leading Contract Research Organization (CRO), is seeking a Principal Clinical Quality Assurance Specialist to join their team. The Principal Quality Assurance Specialist is a seasoned Clinical QA professional responsible for conducting GCP audits, supporting regulatory inspections, as well as strengthening compliance and quality systems across the organization. This role partners closely with the VP of Quality Assurance and serves as a key quality resource, leading audit activities and supporting process improvement initiatives in a clinical research environment.
The ideal candidate will demonstrate strong attention to detail, proactive problem-solving skills, and a collaborative mindset, which will align successfully within the organization.
Job Title: Principal Clinical Quality Assurance Specialist
Location: Bethesda, MD (Remote)
Contract Pay Range: $58/hr - $73/hr W2
Conversion Salary: $120,000 - $150,000
Travel: Up to 25%
What's the Job?
- Verify compliance with GCP regulations, SOPs, and applicable quality standards.
- Conducts audits of clinical sites, vendors, and suppliers.
- Lead and support external audits at investigator sites and vendor facilities.
- Provide ongoing support for the Quality Management System (QMS).
- Lead CAPA investigations and continuous process improvement initiatives.
- Review clinical quality management plans and provide consultative quality support.
- Train and mentor junior staff on quality processes and regulatory requirements.
- Support regulatory authority inspections and inspection readiness activities.
- Participate in business development activities as needed.
What's Needed?
- Strong knowledge of current GCP regulations, FDA requirements, and ICH guidelines.
- Experience conducting GCP clinical site audits and vendor audits.
- Experience supporting regulatory authority inspections.
- Experience working within Quality Systems in a CRO environment.
- Demonstrated experience managing audit findings, CAPAs, and quality improvement activities.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office.
- Ability to travel domestically and occasionally internationally for audit activities.
What's in it for me?
- Opportunity to contribute to impactful clinical research projects.
- Flexible remote work environment supporting work-life balance.
- Engagement with a dynamic and innovative team.
- Chance to develop and refine your expertise in clinical quality assurance.
- Supportive organizational culture committed to professional growth.
Upon completion of waiting period, consultants are eligible for:
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account
- Health Flexible Spending Account
- Dependent Care Flexible Spending Account
- Supplemental Life Insurance
- Short Term and Long Term Disability Insurance
- Business Travel Insurance
- 401(k), Plus Match
- Weekly Pay
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of: Manpower, Experis and Talent Solutions.
Experis® is a global leader in technology services and part of the ManpowerGroup® (NYSE: MAN) family of brands. We connect skilled technology professionals with meaningful opportunities where they can grow their careers, expand their expertise and make a real impact. Guided by the belief that it takes Human Ingenuity to unlock the true potential of technology, Experis helps people gain experience with leading organizations, build sought-after skills and take the next step toward a brighter future. Backed by ManpowerGroup's 75 years of workforce expertise and global reach across more than 70 countries and territories, Experis brings the scale, insight and opportunity to help people and businesses thrive. ManpowerGroup is consistently recognized for its commitment to inclusion, ethics and responsible business, including being named one of the World's Most Ethical Companies. Learn more at Experis.com.
Salary : $120,000 - $150,000