Quality Systems Lead

Quality Systems Lead

Key Responsibilities of this role include:

• Responsible for ongoing development of the  Quality systems.
• Support the QSHE lead in the continuous improvement of the overall companies Quality Management system.
• Ensuring the Quality Systems meet current legislation, industry standards and customer requirements.
• Lead and manage the operational performance of the Quality systems while ensuring the successful delivery of business objectives.
• Ongoing Development and tracking of agreed Quality KPIs and co-ordinating the monthly review process.
• Own the inspection readiness program and hosting all regulatory, customer and certification audits and inspections.
• Management of supplier and raw material approval protocol ensuring all suppliers approved with specifications in place pre-purchase. Manage incoming material inspection and release.
• Facilitate review and approval of change control and deviation records.
• Product Recall process improvement and lead the mock recall process annually.
• Management of the overall CAPA program, ensuring corrective and preventative measures taken when deviations noted.
• Development and implementation of the Annual Business Quality Review program
• Lead the customer complaints management process.
• Lead the supplier non-conformances with corrective action and preventative measures.
• Maintain competent authority authorisations, including submission of variations.
• Communicate routinely with key stakeholders all aspects of quality activities.
• Ensure all Quality Assurance activities support routine production needs working closely with the Quality Control lead/designate.
• Complete validation and qualification activities as required, providing expert guidance.
• Manage the internal audit program.
• Carry out Quality Assurance review of both batch documents and Quality Control/Microbiological data to support batch release.
• Continuously review and improve the process for batch release while ensuring batch release is within the service level agreement.
• Support the review of IT Quality System selection and lead the implementation plan.

Requirements for this job include:

• Bachelor`s Degree in a technical discipline to include Science, Quality or Engineering. Master`s degree a plus.
• Minimum 10+ years experience in a Quality leadership role, with at least 5 years in process-based manufacturing for the food and/or pharmaceutical industry.
• Proven record in developing and implementing successful Quality systems and procedures.
• Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven.
• Excellent computer skills, experience with MS Office, ERP systems, IT Quality system software etc.
• Ability to interface with and effectively communicate with a broad range of customers, cross functional teams, as well as executive management.
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention to detail.
• Excellent Working knowledge of ISO 9001, FSSC22000 and HACCP standards