Quality Manager - Thermo Fisher Scientific

Position Summary: Provide leadership and management for quality activities at the designated Microbiology manufacturing site to ensure that quality assurance, quality systems, quality control testing and quality engineering activities are effective, efficient and in compliance with regulatory expectations and quality standards.

The role is matrix managed. Day to day interactions are with the site’s operations director, however, for all quality assurance matters, quality systems processes and key quality objectives the position reports directly into the Quality Director, Europe.

Key Responsibilities (General):

• Responsible for compliance to mandatory regulatory requirements including Quality Management Systems standards e.g. ISO 9001, ISO 13485, ISO 17025, FDA and the In Vitro Diagnostics Directive.
• Drive continuous improvement through PPI to deliver improved performance from a quality, service and cost point of view.
• Responsible for the release of product to external and internal acceptance criteria.
• Drive, champion and promote quality practices and behaviours across the site.
• Lead and develop staff within the function to a high level of competency and performance. Set clear, comprehensive expectations demonstrate role model leadership; provide meaningful, timely feedback about performance, train and coach to continuously improve individual performance and business results.
• Prepare and monitor site quality objectives and provide metrics and quality input to the site Senior Leadership Team and the Divisional QRA function.
• Responsible for the health and safety of staff and visitors, including contractors, within the areas supervised and for ensuring that the environment is not adversely affected by the activities of the employees and visitors for whom they are responsible.
• Provide technical and quality support to the business.
• Any other tasks/duties deemed to be within the competence of the post-holder.

   

Key Responsibilities (QA):

• Manage fundamental quality system process to ensure compliance, timeliness and effectiveness e.g. CAPA, change control, audit, management review, supplier control, etc.
• Ensure that all customer complaints are reviewed in a timely manner and escalated appropriately through the vigilance process where required, including notification of reportable events to regulatory authorities.
• Prepare the site for, and host, external audits (customer/regulatory) ensuring corrective/preventative actions are put in place to address non-conformances.
• Review ongoing development of the Quality System to ensure and improve its effectiveness through ownership of the management review process.
• Ensure that validation system is in compliance with relevant external (regulatory) requirements including ISO, QSR and IVDD.
• Maintain awareness of new relevant regulatory requirements and to alert staff of required system and/or procedural changes.
• Lead the quality engineering practices ensuring partnership with the Operations teams on production issues, training and SOP compliance, root cause analysis, CAPA implementation and other Quality related matters

Key Responsibilities (QC):

• Oversee work scheduling, planning, and general administration of the Product Performance laboratory to ensure targets are met within agreed timeframes.
• Ensure PP testing is carried out in accordance with product specifications and external quality control requirements.
• Monitor, record, analyse and report on activities, trends, results and recommendations relating to product performance and department activities.
• Notify operations director and supply chain of work progress and alert where necessary
• Liaise with Planning, Purchasing and Marketing to ensure work is prioritised as required
• Develop and maintain systems to measure performance against established standards
• Provide information in response to technical enquiries 

Minimum Requirements/Qualifications:

• Five years management experience in an IVD Quality Assurance/ environment.
• Knowledge of regulatory requirements including ISO 13485, 9001, 17025 and the IVD Directive.
• Degree in a Biological Science or QA discipline.
• Experience in microbiology
• Quality Control experience/knowledge

Non-Negotiable Hiring Criteria:

• Experience in QA and IVD/MDD.
• Managerial experience.
• Degree in a Biological Science or QA discipline.