Job Description
My client a leading and rapidly expanding Pharmaceutical Company now require a Senior Associate Director Quality Assurance – Incident Management to join their rapidly expanding team.
The Associate Director Quality Assurance – Incident Management is responsible for the management of quality incidents to remediate risk. They will ensure QAM and MAC forums occur in a timely maner with all required detail to facilitate decision making, ensuring appropriate, timely consistent decision making during the management of Quality Incidents
They will ensure compliance with regulatory reporting requirements. With implementation of CAPA actions to remediate defect issue and will ensure required recall actions can remove the maximum percentage of impacted product from the market.
This is a permanent role based in Dublin City Centre and has a great degree of flexibility including some work from home.
Responsibilities of Associate Director Quality Assurance – Incident Management
- 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
- Bachelor’s degree in a relevant scientific/engineering discipline with at least 5 to 7 years GMP industry experience, the majority of which is gained in the QA environment and includes manufacturing related experience.
- Working knowledge of Regulations, US and EU Regulations, including GMPs and GDPs
- Knowledge of GxP and regulatory reporting requirements and guidelines
- Use of Quality Risk Management methodologies, particularly risk assessment and root cause analysis
- Drive tenacious leadership behaviours through day-to-day activities and results focus
- Ability to build collaborative working relationships with OpU, Regional and Global leaders
- Positive continuous improvement culture and knowledge of applicable methodologies including Blue- and GreenBelt projects
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below