PRINCIPAL, QA

Technical Resources International, Inc.; North Bethesda (MD); On-site; USD 120,000 - 145,000; Full time

Job summary

Technical Resources International, Inc. in Bethesda, MD, seeks a Principal, QA to lead GCP compliance and audits within our clinical quality program. This full-time role focuses on regulatory readiness, CAPA investigations, and ensuring adherence to SOPs.

You will mentor staff, support inspections by regulatory authorities, and contribute to business development efforts. A Bachelor's degree and strong knowledge of current GCP regulations are required.

Qualifications

• Strong knowledge of current GCP regulations
• Experience with regulatory authority inspections
• Experience working with Quality Systems for CROs
• Experience conducting GCP clinical site audits
• Proficiency in MS Office

Responsibilities

• Verifies GCP compliance to applicable 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 knowledge

Regulatory inspections

CAPA investigations

Quality Systems

Education

Bachelor's Degree

Tools

MS Office

Job description

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Job Title

PRINCIPAL, QA

Location

Bethesda, MD 20817 US (Primary)

Category

Quality Assurance

Job Type

Full-Time

Salary Range

$120,000–$145,000/YR

Education

Bachelor's Degree

Travel

Up to 25%

Job 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

Job Requirements

• Strong knowledge of current GCP regulations
• Experience with regulatory authority inspections
• Experience working with Quality Systems for CROs
• Experience conducting GCP clinical site audits
• Proficiency in MS Office

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.