Director Quality Risk Management - 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.

We are seeking a highly skilled and experienced Director of Quality Risk Management to join our Quality Assurance (QA) department, specifically overseeing clinical research. This newly created role is integral to our commitment to incorporating Quality by Design (QbD) into our clinical research programs, in alignment with the ICH Q9 and ICH E6as well as Food and Drug Administration (FDA) and European Medicinal Agency (EMA) guidelines on risk management. The Director will work closely with therelevant stakeholders for establishing processes for management (identification, analyzation, control, communication, review and reporting of risks) of critical to quality factors holistically.Establishes and oversees their execution ofcollaboration, communication and escalation pathways with CRAs, Central Monitors, Data Management, vendors, process owners and others as needed to analyze risks and issues using quality performance data, to identify follow up actions and to oversee completion of identified actions. This position will also support governance and oversight of system level risk management in collaboration with SCRI IT, Validation and quality assurance teams, including QA audit.

Duties include and are not limited to:

Strategic Leadership

• Develop and implement a comprehensive Quality Risk Management (QRM) all inclusive (CRO, SMO, & QA) strategy aligned with the ICH Q9, ICH E8 and ICH E6 R3, as well as FDA and EMA guidance documents.
• Establish the QRM framework within the QA department, fostering a culture of risk awareness and continuous improvement.

Quality by Design (QbD)

• Integrate QbD principles into clinical trial processes to ensure that quality is built into study design and execution from the outset.
• Facilitate and/or coaching cross-functional teams on understanding and execution of QbD principles and supporting processes, including but not limited to the implementation of protocol de-risking, and Risk Based Monitoring (RBM) approaches
• Collaborate with cross-functional teams to ensure that critical to quality factors are proactively identified, analyzed, monitored, and controlled throughout the trial lifecycle.

Risk Identification, Analyzation, and Mitigation

• Establish procedures for proactive identification, analyzation, and mitigation strategies for identified risk during a trial set up.
• Utilize data driven insights to proactively identify potential risks and trends that may impact the quality and integrity of clinical trials during conduct phase.
• Develop and implement risk mitigation strategies and action plans in collaboration with QA Audit, Training, Quality Governance, Research Operations, and investigator sites.

KPIs KRIs and Performance Metrics

• Establish, monitor, and report on KP/RIs aligned with critical to quality factors.
• Conduct regular reviews and analyses of performance metrics to identify areas for improvement and drive corrective and preventive actions.
• Research data to establish Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs) aligned with pre-defined critical to quality factors, as well as protocol and trial specific risks.

As well as Oversight, Partnership and Collaboration, Training and Development, and Continuous Improvement

Qualifications needed and preferred include:

• Bachelor's Degree required, Master's degree preferred
• Significate experience of 10 years' preferred in clinical research and quality assurance, with at least 5 years in a leadership role focused on risk management
• A proven track record of successfully implementing QbD principles in clinical research, including but not limited to protocol derisking and Risk Based Monitoring approaches (RBM)
• In-depth knowledge of regulatory guidelines (e.g. ICH E6, ICH Q9, guidelines) GCP, and other relevant regulatory requirements.

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.