Director, Clinical QA Management RWE Clinical Trials - Remote

Walgreens; Deerfield (IL); Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player in healthcare is seeking a Director of Clinical Quality Assurance Management. This pivotal role involves overseeing quality activities for clinical trials, ensuring compliance with Good Clinical Practice (GCP) standards, and leading a team of QA professionals. The ideal candidate will possess extensive experience in clinical operations and quality management, demonstrating strong leadership and communication skills. Join a dynamic organization committed to improving healthcare services and making a difference in the lives of millions. This is an exciting opportunity to drive quality initiatives and enhance performance in a collaborative environment.

Qualifications

• Deep understanding of GCP, CFR, and ICH guidelines.
• Experience managing clinical quality activities and audits.

Responsibilities

• Ensure compliance with SOPs and QMS for clinical trials.
• Lead and manage a QA team, ensuring effective training.

Skills

GCP (Good Clinical Practice)

Clinical Operations

Leadership Skills

Regulatory Compliance

Communication Skills

Problem Solving

Financial Decision Making

Education

Bachelor's Degree in Life Sciences or related field

Advanced Degree (e.g., Master's, PhD)

Tools

Quality Management System (QMS)

Audit Management Tools

Job description

Job Summary

The Director, Clinical Quality Assurance Management for the RWE Clinical Trial business will be responsible for the management and operational oversight of the quality activities for the broader business and clinical trial site level to ensure Walgreens conducts its trials to the highest quality and regulatory obligations and enhances performance through continuous improvements. This will also include the need to proactively assess and identify risks, tackle unplanned deviations, corrective/preventative actions, and proactively monitor and trend quality issues to ensure the business is performing to Good Clinical Practice (GCP) standards.

This role will also be responsible for leading Quality Assurance (QA) professionals.

Job Responsibilities

1. Ensure Standard Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory and other relevant frameworks, making recommendations for improvement where appropriate.
2. Identify appropriate staff SOP training requirements and maintain oversight of training to ensure all Walgreens clinical trials staff are trained on SOPs.
3. Implement and maintain a Quality Management System (QMS) in line with the Corporate QMS and take the lead in presenting it to internal stakeholders, pharmaceutical companies, and other funding partners.
4. Build, manage, lead and motivate a QA team, ensuring that people with the right range of skills and experience are recruited and retained, and that their skills and professional capabilities are maximized.
5. Ensure quality and operational compliance; act as a subject matter expert for quality investigations, documentation systems, training programs, internal/external audits, and vendor assurance programs.
6. Develop and implement a risk-based and flexible approach to QA in compliance with applicable regulatory requirements.
7. Generate and analyze weekly, monthly and quarterly metrics to track KPIs.
8. Work with the Operations team to implement, review and maintain tracking of incidents within the clinical trials, advising on CAPAs to be implemented and ensure completion in a timely manner.
9. Lead the Audit Program management process, including assessment of internal and external (outsourced) operations, and active audit and regulatory inspections.
10. Partner with functional areas in study design, data collection, analysis, and reporting activities that support quality improvement interventions, transparency, compliance with regulatory standards, and provide performance monitoring.

About Walgreens

Founded in 1901, Walgreens (www.walgreens.com) has a storied heritage of caring for communities for generations and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni-channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members, and communities.

Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy, and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients’ care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.

Qualifications

1. Comprehensive, excellent understanding of GCP, CFR and ICH guidelines.
2. Significant experience with managing clinical quality activities and in-depth knowledge of clinical operations.
3. Significant experience in clinical trial site/process audits and regulatory inspections.
4. Experience in line management of employees.
5. Experience translating Pharma/Sponsor needs for innovation and creative approaches to quality management.
6. Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team.
7. Excellent verbal and written communication and presentation skills.
8. Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a start-up environment.
9. At least 2 years of experience contributing to financial decisions in the workplace.
10. At least 3 years of direct leadership, indirect leadership and/or cross-functional team leadership.
11. Willing to travel up to 15% of the time for business purposes (within state and out of state).