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Director of Quality Risk Management System

Reference:SCANOO-541725 Location: Limerick
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Director of Quality Risk Management System
Our client, a leading biotech organisation are currently recruiting for a Director Quality Risk Management System. As Director Quality Risk Management System you will be global process owner of the end to end Global Quality Risk Management System across global functions at sites, including combination product development, Drug substance and drug product clinical and commercial production. You will be responsible for ensuring adoption of Risk Management principals is applied across disciplines and lifecycle through close collaboration with Senior Leaders and key stakeholders.

• Provide leadership to the Global Quality Risk Management team. Manage and continually improve Quality Risk Management (QRM) system supporting groups
• Formulate risk management strategies, principles, methods and tools, and document in appropriate policies, procedures, and reports
• Educate and train staff in quality risk management principles and practices and act as a subject matter expert and resource for QRM matters
• Manage and lead data driven risk assessments (risk identification, analysis and ranking)
• Responsible to develop and manage data analysis and statistical tools used to support quality risk management activities
• Oversee QRM program to ensure risk assessments are conducted as required frequencies and manage the overall process, tasks, and communications
• Communicate the outcome from quality risk management activities to all business partners
• Work with the management team to integrate quality risk management concepts and philosophies into the overall Quality System
• Function as a fully integrated member of the Quality Assurance management team, advising on all QRM matters within the organisation, as well as being the primary interface with customers
• Represent the organisations approach to Quality Risk Management during regulatory inspections and partner audits. Serve as the Subject Matter Expert in Risk Management Governance processes
• Author/revise Risk Management policies and procedures to align with current business and regulatory requirements. In addition, create, implement, and manage Quality Metrics Program and Management Review governance policies and procedures
• Create, facilitate and chair standing cross-functional QRM Escalation Council where all GxP product and process high risk items are escalated, discussed, mitigated, and documented in accordance to written procedures and standards
• Working with cross-functional teams, create, maintain and publish a monthly Quality Performance Metrics/Key Performance Indicators.
• Create, implement, and facilitate standing Management Review meetings where Quality KPI's and other risks are escalated, communicated, and documented
• Provide ongoing collaboration, engagement, and education to cross-functional teams members in the application and compliance of risk assessment and mitigation processes
• Partner with cross-functional colleagues to meet compliance requirements and business needs
• Identify and implement continuous improvement projects related to Quality Risk Management, Quality Metrics, and Management Reviews

• Requires BS/BA in Life Sciences with 10+ years of relevant progressive experience in QA/QRM/Manufacturing/Validation within the Pharma / Biopharma industry
• Previous Quality and or Risk Management experience required
• Must possess effective and positive leadership skills including effective team work and collaboration, engagement, negotiation, impact change, escalation, transparent, and identifying issues and solutions
• Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment
• Ability to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner
• Must possess excellent communication skills, both verbal and written
• Strong self-motivation as well as the ability to work independently, and in a team environment with minimum supervision
• Ability to use critical thinking, resolve issues, and deal with a variety of variables in situations where general standardization does not yet exist
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Strong follow-up and organizational skills
• Ability to identify situations which will require management intervention for resolution. Ability to assess regulatory/compliance risk identify areas of improvement and propose practical solutions.
• Must possess proficient knowledge of Microsoft Word, Excel, Power Point, and other systems such as, SharePoint, etc

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252