QA Specialist / QA Manager (Clinical Quality Assurance)

Commitment:

Location:

Reports To:

Position Overview

QA Specialist / Manager-level contractor

Key Responsibilities

• Serve as the primary QA support resource for clinical study teams, ensuring compliance with GCP and internal quality standards.
• Provide QA expertise during study calls, including:
• Protocol deviation meetings
• Risk-based quality management discussions
• Study operations and trial oversight meetings
• Write, review, update, and format

  standard operating procedures (SOPs)

  and other quality documentation.
• Manage and track quality processes within

  Veeva QMS

  , including document control, training, and CAPA management.
• Address QA-related questions from study teams in real time, providing clear and actionable guidance.
• Support inspection readiness and contribute to continuous improvement of QA systems and processes.
• Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation.

Qualifications

• Education:

  Bachelor’s degree in life sciences, healthcare, or related discipline (advanced degree preferred).

• Experience:

• 5+ years of

  Clinical Quality Assurance

  experience with a strong foundation in GCP.
• Prior experience supporting clinical study teams in a QA capacity.
• Hands-on experience with

  Veeva QMS

  .

• Technical Skills:

• Proficient in MS Office (Excel, PowerPoint, Word).
• Skilled in technical writing, SOP drafting, and document formatting.

• Soft Skills:

• Excellent communication and interpersonal skills.
• Strong organizational skills with the ability to work independently.

• Availability:

  Must be available during

  Eastern or Mountain Time Zone working hours

  to attend study calls and provide timely QA support.

Contract Opportunity

full-time contract role