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Actalent

Clinical Research QA Manager

Actalent, Bethesda, Maryland, us, 20811


Clinical Research QA Manager Must have Clinical Research industry experience Must have management experience Manage a team of clinical QA personnel while also conducting both internal and external audits within GCP guidelinesConducts clinical site audits (domestic and international) verifying regulatory compliance and protocol complianceVerifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulationsReviews clinical audit reports and provides guidance to auditorsSupports inspection readiness programServes as a subject matter expert for qualityPromotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management SystemHosts client audits, conducts external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigationsSupports regulatory authority inspection Qualifications Must have management/supervision experience (minimum of 2 -3 years)Understanding and working knowledge of GCP (minimum 5 years)Experience working with eQMSTravel 10-20% (domestic and international). 1 domestic trip every other month. 1+ international trips per yearMinimum a B.S/B.A., Certified Quality Auditor (CQA) preferred, advanced degree preferredAbout 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people 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.