Our client is a major multinational biopharmaceutical company with an exciting drug portfolio driving double digit growth, creating highly attractive new career development and advancement opportunities at their globally focused Dublin city HQ.
- Management of quality incidents to remediate risk
- Ensure QAM and MAC forums occur in a timely manner with all required detail to facilitate decision making
- Ensure appropriate, timely consistent decision making during the management of Quality Incidents
- Ensure compliance with regulatory reporting requirements
- Implementation of CAPA actions to remediate defect issues
- Ensure required recall actions are capable of removing the maximum percentage of impacted product from the market
Primarily responsible for managing the Global Incident Escalation Process and associated outputs.
- Owns Quality Incident record from beginning to end
- Assists sites / incident owners with information gathering and preliminary assessments
- Reviews incoming incident forms for accuracy and content
- Reviews and approves QAM and MAC slide decks
- Oversees QAM and MAC meetings and coordinates actions
- Assists Incident Management Coordinator with scheduling, record management and communications, where required
- Assists with decision making before, during and after an incident is escalated and liaises with relevant functions to ensure that the incident is logged, actioned and closed within the required timelines
- Coordinates all actions coming out of the escalation meeting, including review and submission of regulatory notifications – FAR, BPDRs, PDRs, Type C Meetings etc.
- Acts as global lead for any Field Corrective Action resulting from the incident
- Liaison with Investigations team to monitor implementation of CAPAs and other actions
- Monitors performance of the Incident Escalation Process via periodic report-outs
- Assists with compilation of APQRs and Quality Councils and provides data to audit teams
Responsible for global coordination of Field Corrective Actions, including recalls, DHPCs and market corrections.
- Establishes FCA team and and ensures that FCA actions are carried out according to procedures.
- Monitors effectiveness of recall and other actions and measures effectiveness via actual and mock recalls.
Responsible for Quality Management and Continuous Improvement of QIM process
- Business Process Management of QIM, FCA, Defect Reporting, Product Hold and Drug Shortage Notification SOPs. Responsible for ensuring and monitoring business process effectiveness
- Responsible for driving continuous improvement, through weekly team meetings, BPM effectiveness, Bluebelt projects and ad hoc CI initiatives
Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
- Knowledge of GxP and regulatory reporting requirements and guidelines
- Use of Quality Risk Management methodologies, particularly risk assessment and root cause analysis
Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
- Be positive, accountable, results-orientated
- Be an excellent manager of self and others
- Drive tenacious leadership behaviours through day-to-day activities and results focus
- Ability to build collaborative working relationships with OpU, Regional and Global leaders
Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
- Must be able to critically evaluate potentially complex issues, in order to triage, escalate and remediate them
- Solves difficult problems while maintaining quality standards and understanding business requirements
Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
- Building team relationships to ensure cross-functional interaction
- Chairing and running of meetings, ensuring attendance, interactive discussion and round table endorsement of recommendations
Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
- Positive continuous improvement culture and knowledge of applicable methodologies including Blue- and Greenbelt projects
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- Able to understand and assist in solving difficult cross functional problems / issues as potentially associated with other -owned functions.
- Capable of risk prioritisation and contingency planning, to address complex, multi-layered issues
Bachelor’s degree in a relevant scientific/engineering discipline with at least 5 to 7 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing related experience. Working knowledge of Regulations, US and EU Regulations, including GMPs and GDPs
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