Director, Validation Center of Excellence - remote US

It’s More Than a Career, It’s a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

The Director of the Validation Center of Excellence (VCOE) will lead a dynamic team of software validation specialists, ensuring the integrity and compliance of computerized systems within our organization. This role is critical in supporting clinical research initiatives by providing expert consultation and oversight, ensuring that all computerized systems meet regulatory and quality standards.  This position is based in the US and fully remote.

Duties include and are not limited to:

• Guiding a talented group of software validation specialists. Your leadership will inspire them to reach new heights, ensuring the delivery of top-notch software solutions.

• Create an environment where creativity thrives. Encourage team members to share ideas, collaborate, and push the boundaries of what's possible in software validation.

• Elevating your team's skills with cutting-edge training initiatives. Empower them to enhance their expertise, stay ahead of industry trends, and continually improve their capabilities.

• Craft and oversee comprehensive validation strategies that ensure our computerized systems are reliable, efficient, and future-ready. Your strategic vision will be the cornerstone of our success.

• Navigate the intricate landscape of GxP, FDA, and ICH guidelines with precision. Your deep understanding and commitment to compliance will safeguard our processes and products, maintaining our reputation for excellence.

• Define and sustain the gold standard for validation processes. Your insights will drive the continuous improvement and innovation needed to keep us at the forefront of the industry.

• Be the cornerstone of our clinical research initiatives by offering unparalleled validation expertise. Your insights will ensure the integrity and reliability of our research outcomes.

• Work hand-in-hand with cross-functional teams, sharing your wealth of knowledge on validation requirements and best practices. Your collaboration will streamline processes and enhance the quality of our projects.

• Play a crucial role in crafting and executing detailed validation protocols and comprehensive reports. Your support will be vital in documenting our commitment to excellence and compliance.

• Facilitate VCOE involvement in audits and taking the lead in developing and implementing robust responses to audit observations. Your proactive approach will address validation concerns swiftly and effectively, maintaining our standards of excellence.

Qualifications include

• Bachelor’s degree required, Master’s Degree preferred

• 7+ years’ experience as the Subject Matter Expert of Computerized System Validation including requirements, compliance with 21 CFR Part 11 including EU regulations.     Annex 11 is a +.

• Knowledge of industry and international standards for software quality such as GAMP V, PIC/S, ICH, etc

• Work experience in Clinical Research, Pharmaceutical, Biologics, medical device with 21 CFR Part 11 requirements and software validation principles. 

• Certification in Computerized Systems Validation or related field is highly preferred.

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies appr