Senior QA Lead, Early-Phase Clinical Research

150 Altasciences Clinical Kansas Inc; Kansas (OK); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid vacation

Sick leave

EAP & Telehealth

Job summary

Altasciences is seeking an experienced Manager, Quality Assurance to lead QA teams and ensure compliance with GxP and regulatory requirements across early-phase clinical programs.

You will oversee audits, risk-based QA planning, and quality systems while partnering with clinical operations to mitigate risks to drug development and patient outcomes. Strong leadership and communication skills are essential.

Qualifications

• Bachelor-level degree in a life science field or higher.
• Minimum 5 years of related experience in QA/Regulatory.
• At least 2 years of supervisory experience.
• Experience in pharmaceutical/clinical research environments.
• Knowledge of GCP, GLP, and GMP regulations.

Responsibilities

• Lead QA staff and resource planning to ensure timely QA activities.
• Provide coaching, performance feedback, and staff development.
• Oversee audits, inspections, and deviation investigations.
• Maintain QA systems and ensure regulatory compliance.
• Support inspection readiness and sponsor audits.

Skills

QA Leadership

GCP Knowledge

Auditing

Regulatory

Risk Management

Cross-functional

Communication

Education

Bachelor degree in Chemistry/Biochemistry/Biology

Tools

MS Word

Excel

Outlook

PowerPoint

Job description

Altasciences is seeking an experienced Manager, Quality Assurance to lead QA teams and ensure compliance with GxP and regulatory requirements across early-phase clinical programs.

You will oversee audits, risk-based QA planning, and quality systems while partnering with clinical operations to mitigate risks to drug development and patient outcomes. Strong leadership and communication skills are essential.