Vice President, Clinical Quality Assurance - Remote

Key responsibilities

• Develop and implement enterprise-wide quality assurance strategies and programs.
• Ensure compliance with GCP, GxP, FDA, HIPAA, accreditation standards, and other applicable regulations.
• Lead cross-functional quality improvement initiatives and drive quality performance outcomes.
• Oversee internal and external audits, findings management, corrective actions, and quality reporting.
• Monitor quality metrics, identify risks and deficiencies, and provide recommendations to executive leadership.
• Maintain and enhance quality policies, procedures, and standard operating processes.
• Advise research and operational teams on regulatory compliance and quality best practices.
• Partner with training and education teams to support compliance and continuous learning initiatives.
• Establish departmental goals, manage budgets, allocate resources, and oversee workforce planning.
• Lead, mentor, and develop quality teams while fostering a culture of engagement, accountability, and excellence.
• Build strong relationships with senior leaders and cross-functional stakeholders across Sarah Cannon Research Institute, our partners, and McKesson.

• Minimum Bachelor’s Degree;
  Master’s Degree preferred in a related field.
• Minimum 10 years’ related experience including supervisory roles, interacting with regulatory authorities, quality assurance auditing in a clinical research organization, sponsoring company, or pharmaceutical corporation.
• Minimum 10 years’ experience in a clinical trial environment, knowledge of quality systems including CAPA, change control, deviations, and investigations.
• People management and leadership experience required.
• Extensive knowledge of FDA guidelines, GCP, and applicable regulations.
• Quality and Clinical IT Systems knowledge as well as knowledge of medical and clinical research terminology.
• Thorough understanding of investigative site research requirements.
• Thorough understanding and knowledge of quality metrics and performance measures.
• High level of technical proficiency with multiple quality systems including Veeva, as well as all MS Office products.

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 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade.

SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.

We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight-year-old boy battling cancer.

This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. We have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.