Site Lead

KENNY-WHELAN AND ASSOCIATES

WATERFORD

Kenny-Whelan are sourcing a General Manager responsible for Site Operations and Busness Development for our client, who provide integrated state of the art Laboratory Services and Products across Pharma/Biopharma/Med device and Life science industries. Contact Jenn Dinan on 0214665408 and email jdinan@kenn-whelan.ie. General Manager (Ireland) Reports to: CEO Accountable to: CEO Relationships: • Finance Team • Commercial Teams • Exec Team • Senior Manager – Stability Storage & Serology • HR • QA Team • IT Team • Facilities Team • Clients/Customers • Suppliers Summary: Summary. Day to day management of the Irish business, including business development and site management. Management of the Tramore facility which is composed of the Stability Storage suite , DNA Sequencing Laboratory and Micro and Sterility Lab. To generate increasing sales and business development opportunities for storage and laboratory testing facility in Ireland. The overall objective is to deliver services from the portfolio to customers to ensure that the activities are performed within the quality performance indicators and according to the relevant Standard Operating Procedures and that the integrity of the customer supplied products and samples are maintained at all times. The post-holder will be expected to work to quality standards, financial rgulations, operational deadlines and lead new quality initatives. Key responsibilities and duties include but are not limited to: • Reporting to the CEO, have responsibility for the development and operation of the Irish business. Leading and managing the stability storage and life science team to ensure efficient and effective operation of the suite at all times. Senior responsible person for the site facilities, including ensuring that all local licences are adhered to and the point of contact for client enquiries in Ireland. Liaising with clients and UK staff to ensure that clients receive complete and accurate information concerning practical operation of the suite and laboratory. Ensuring FDA, ICH and GMP regulations are always applied and adhered to throughout the suite. Hosting client audits. Provide complete, accurate and timely management information including reporting capacity levels and issues in a timely and accurate fashion to relevant stakeholders. Working with the finance team to ensure that all work is accurately invoiced. Working with the COO to lead initiatives within the site that will ensure the most efficient and effective management of the Operational areas. Co-ordinating with relevant staff to ensure effective validation and servicing of suite equipment as necessary. Reporting of all out of Specification incidents, deviations and Customer Complaints to the Quality Assurance Officer in accordance with SOPs. Ensuring peripheral equipment (e.g. data loggers, elgas, etc) is operational at all times, reporting of equipment breakdowns in a timely fashion. Maintaining critical spares in accordance with suite requirements. To generate increased sales in the laboratory services provided out of Tramore. Performing the duties of the storage technician or sequencing scientist as required, to ensure the smooth running of the suite. Able to work supportively as part of a team with a friendly and approachable personality. Support the Quality team and Auditors maintaining: ISO 9001 Quality System requirements, EU (Directive 2003/94/EC) and USA (CFR 21 Part 210/211) current Good Manufacturing Practice regulations and HTA regulations. 21 CFR Part 11 regulations – FDA guidelines for electronic records and electronic signatures ICH Topic Q1A (R2) – Stability Testing of New Drug Substances and Products ICH Topic Q1B (R2) – Photostability Testing of New Active Substances and Medicinal Products. • Preparation and completion of all relevant documentation and data acquisition systems. To comply with all quality control procedures to support maintenance of the Quality Management System. To comply with safe working practices in accordance with Company safety policies. To perform any other duties as may be reasonably be required commensurate with grade and experience. Attend training endeavours as appropriate to the role as reasonably requested. All applications will be treated with the strictest of confidence. Contact Jenn Dinan on 0860466583 and email jdinan@kenny-whelan.ie.

1425 days ago