At least 6 years
Description
- Verifies GCP compliance to applicable Standard Operating Procedures (SOPs) and regulations
- Conducts audits of clinical sites and vendors/suppliers
- Provides full support to the Quality Management System
- Conduct external audits at clinical sites and vendor sites
- Leads process improvement activities and CAPA investigations
- Reviews clinical quality management plans and provides consultative support to clinical sites (as applicable.
- Trains junior staff on regulations and quality processes
- Supports regulatory authority inspections
- Supports business development activities, as requested
Skills
GCP, Audit, Clinical Quality Assurance, CAPA, Regulatory Compliance
Additional Skills & Qualifications
- Strong knowledge of current GCP regulations
- Experience with regulatory authority inspections
- Experience working with Quality Systems for CROs
- At least 6 years of experience conducting GCP clinical site audits
- Excellent written/verbal communication skills
- Proficiency in MS Office
Experience Level
Expert Level
Job Type & LocationThis is a Permanent position based out of Bethesda, MD.
Pay and BenefitsThe pay range for this position is $120000.00 - $145000.00/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 TypeThis is a hybrid position in Bethesda,MD.
Application DeadlineThis position is anticipated to close on Sep 11, 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.
Posting ID: JP-006261198