Director Quality Risk Management – Remote US
Company: McKesson
Location: Tennessee, Remote
Job ID: JR0122594
Category: Regulatory Monitoring, Compliance & Legal
Post Date: Jan. 07, 2025
It’s More Than a Career, It’s a Mission.
Join our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, and become part of one of the largest community-based cancer programs. We are transforming care and personalizing treatment through clinical excellence and cutting-edge research.
We are seeking a highly skilled and experienced Director of Quality Risk Management to join our Quality Assurance (QA) department.
This newly created role is integral to our commitment to incorporating Quality by Design (QbD) into our clinical research programs.
Responsibilities:
- Develop and implement a comprehensive Quality Risk Management (QRM) strategy.
- Establish the QRM framework within the QA department.
- Integrate QbD principles into clinical trial processes.
- Facilitate cross-functional teams on understanding and execution of QbD principles.
- Establish procedures for proactive identification, analyzation, and mitigation strategies for identified risk.
- Utilize data-driven insights to proactively identify potential risks and trends.
- Develop and implement risk mitigation strategies and action plans.
- Establish, monitor, and report on KP/RIs aligned with critical to quality factors.
- Conduct regular reviews and analyses of performance metrics.
- Research data to establish Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs).
Qualifications:
- Bachelor’s Degree required, Master’s degree preferred.
- 10+ years of experience in clinical research and quality assurance, with at least 5 years in a leadership role focused on risk management.
- Proven track record of successfully implementing QbD principles in clinical research.
- In-depth knowledge of regulatory guidelines (e.g. ICH E6, ICH Q9, guidelines) GCP, and other relevant regulatory requirements.
Benefits:
- Competitive compensation package.
- Comprehensive benefits to support physical, mental, and financial well-being.
We are an equal opportunity employer and value diversity at our company.
How to Apply:
To apply for this position, please visit the McKesson website and search for Job ID JR0122594.
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.
Please click the link below to learn more about our research offerings.
SCRI website: https://sarahcannon.com/service/oncology-research
We care about the well-being of the patients and communities we serve, and that starts with caring for our people.
McKesson benefits page: https://www.mckesson.com/Careers/Employee-Benefits/
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.
