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 guidelines

Conducts clinical site audits (domestic and international) verifying regulatory compliance and protocol compliance

Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations

Reviews clinical audit reports and provides guidance to auditors

Supports inspection readiness program

Serves as a subject matter expert for quality

Promotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System

Hosts client audits, conducts external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigations

Supports 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 eQMS

Travel 10-20% (domestic and international). 1 domestic trip every other month. 1+ international trips per year

Minimum a B.S/B.A., Certified Quality Auditor (CQA) preferred, advanced degree preferred

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 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.