Associate Director, Quality Risk Management
Posted on Apr 6, 2021 by CRISPR Therapeutics AG
The position will establish and lead CRISPR's Quality Risk Management group.
The position will act as the Risk Champion and system owner for the CRISPR Quality Risk Management program and processes
This group will support all functions across CRISPR, including Quality, Operations, and IT.
Primary responsibilities are focused on providing overall leadership and direction for CRISPR's risk management and business continuity efforts to help our sites (internal and external) achieve the changes required to develop and embed risk management as a core business and operational process for CRISPR.
Act as primary lead to help CRSP develop and embed risk management as a core business and operational process, implementing a set of risk indicators, reports, and identifying key risk exposures and early warning indicators.
Ensure Quality representatives are assigned for all formal Risk Assessment teams at CRISPR.
Ensure that the Risk Management program at CRSP is compliant with corporate policies and procedures as well as current regulatory requirements and industry best practices
Ensure that Risk Assessments meet the requirements of CRISRP standards and procedures, are clearly written, and appropriately justified.
Ensure that Risk Assessment records are controlled and managed in a compliant manner throughout their life cycle including storage and archiving, and that the record control system meets the requirements of CRISPR's procedures. Track, oversee and monitor Risk Assessment records at various points in their life cycle, utilizing compliant tracking tools.
Provides guidance to Quality, Operations, IT, and other departments regarding the proper use of the Risk Assessment tools and the risk management process.
Ensure that key users of the Quality Risk Management systems are appropriately trained in regulations and SOPs.
Provide mentoring and guidance to users on the Quality Risk Management system, its compliance, and regulatory requirements. Monitor performance of the risk facilitators.
Monitor the status of open Risk Assessments, providing periodic reports and status updates on the overall performance of the Risk Management program.
Propose and implement modifications to the Risk Management Program to improve compliance, efficiency, and customer satisfaction. Provides timely support to continuous improvement initiatives across the site and the network.
Provides support and defend the Quality Risk Management system during internal and external audits, as necessary.
Create and maintain the site Risk Management Plan, and that risk assessment reviews are performed in accordance with the Plan.
Work with individual system owners to identify and deploy Risk facilitators for formal risk assessments.
Communicate risks to the appropriate stakeholders including the Site Risk Profile Report author, and escalates compliance risks as needed, and proposes countermeasures for identified adverse trends.
Establish and maintain CRSP Program Risk Registers to ensure all risks are appropriately ranked, assessed, and mitigated as necessary.
Masters Degree and 8 years of relevant experience; or bachelor's degree and 10 years of relevant experience; or associate degree and 12 years of relevant experience.
6 years of relevant experience AND 5 years of experience in Risk Management related to Quality support for ongoing GMP manufacturing operations