Director, Clinical QA Management RWE Clinical Trials - Remote

Lensa; Deerfield (IL); Remote; USD 102,000 - 278,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Director of Clinical QA Management for their RWE Clinical Trials. This remote role involves overseeing quality assurance activities, managing a QA team, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in clinical quality management and strong leadership skills.

Qualifications

• Deep understanding of GCP, CFR, and ICH guidelines.
• Extensive experience managing clinical quality activities.
• Minimum 3 years of leadership experience.

Responsibilities

• Oversee quality activities at clinical trial sites.
• Manage a QA team and ensure compliance with GCP standards.
• Implement and maintain a Quality Management System.

Skills

GCP

Leadership

Communication

Interpersonal skills

Adaptability

Resourcefulness

Job description

Director, Clinical QA Management RWE Clinical Trials - Remote

1 day ago - Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Lensa is the leading career site for job seekers at every stage of their career. Our client, Walgreens, is seeking professionals. Apply via Lensa today!

Job Description

Job Summary

The Director of Clinical Quality Assurance Management for the RWE Clinical Trial business will oversee the quality activities at the business and clinical trial site levels to ensure Walgreens conducts trials to the highest quality standards and regulatory obligations. This role involves proactive risk assessment, managing deviations, CAPAs, and monitoring quality issues to ensure compliance with GCP standards. The role will also lead QA professionals.

Job Responsibilities

• Review and update SOPs and internal procedures to ensure compliance with regulatory frameworks, recommending improvements where necessary.
• Identify training needs for staff regarding SOPs and oversee their training to ensure compliance.
• Implement and maintain a Quality Management System aligned with corporate standards, presenting it to stakeholders.
• Build, lead, and motivate a QA team, ensuring the right skills and professional development.
• Ensure operational and quality compliance, acting as SME for investigations, documentation, audits, and vendor assurance.
• Develop a risk-based QA approach compliant with regulatory requirements.
• Analyze metrics to track KPIs regularly.
• Collaborate with Operations to track incidents, advise on CAPAs, and ensure timely resolution.
• Manage the audit program, including internal/external assessments and inspections.
• Partner with study teams on design, data collection, analysis, and reporting to support quality improvements and compliance.

About Walgreens

Founded in 1901, Walgreens serves nearly 9 million customers daily across over 8,500 stores in the U.S. and Puerto Rico. With approximately 220,000 employees, including 90,000 healthcare providers, Walgreens is committed to health and wellness, providing critical pharmacy and healthcare services.

Job Details

Job ID: 1522740BR

Title: Director, Clinical QA Management RWE Clinical Trials - Remote

Company: Walgreens

Employment Type: Full-time

Job Function: Business Development/Planning

Location: 108 WILMOT ROAD, DEERFIELD, IL 60015

Qualifications

• Deep understanding of GCP, CFR, and ICH guidelines
• Extensive experience managing clinical quality activities and operations
• Experience with site/process audits and regulatory inspections
• Line management experience
• Ability to innovate in quality management
• Strong leadership, communication, and interpersonal skills
• Adaptability and resourcefulness
• Minimum 2 years of experience in financial decision-making
• Minimum 3 years of leadership experience
• Willingness to travel up to 15%

Preferred Qualifications

Consideration for employment of qualified applicants with arrest and conviction records.

Compensation

Salary range: $102,000 - $277,600 plus bonus, depending on experience and location.