Quality Assurance Manager (Contract)

TKL Research, Inc. • Fair Lawn, NJ

3d • Hybrid

About The Position

We are seeking an experienced Quality Assurance Manager for our growing organization! In this role, you will be responsible for the review of clinical study documentation. You will handle external and FDA audits, and review SOPs and all other regulatory documents that govern the conduct of the clinical trial. These activities require knowledge of GCPs, ICH, and the applicable parts of the Code of Federal Regulations. You will also be responsible for the oversight and execution of the operational aspects of the Quality Assurance activities.

Requirements

• Minimum Bachelor's degree or equivalent academic credential; health sciences field preferred.
• Minimum of 6 years of working experience within the clinical, regulatory or quality (pharmaceutical / biotech / CRO) field.
• Detailed knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research.
• Excellent organizational skills with the ability to be logical and systematic.
• Excellent written and verbal communication skills.
• Excellent interpersonal skills.
• Ability to function independently with minimal supervision.
• Working knowledge of Microsoft Office Suite.

Responsibilities

• Review of clinical study documentation
• Handle external and FDA audits
• Review SOPs and all other regulatory documents that govern the conduct of the clinical trial
• Oversight and execution of the operational aspects of the Quality Assurance activities

What This Job Offers

• Job Type: Part-time
• Career Level: Senior
• Number of Employees: 11-50 employees