Quality Lead, Facility and Depot Network

Thermo Fisher Scientific
21 Aug 2016
04 Feb 2017
Contract Type
Job Description Company Information About Thermo Fisher Scientific Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $12 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and UnityTM Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com. Job Description Job Title: Quality Lead, Facility and Depot Network Reports To: Quality Director - Facility and Depot Network Group/Division: Biopharma Services Career Band: III Job Track: Professional Position Location: Home Based Number of Direct Reports: 0 Position Summary: The Facility and Depot Network is responsible for the global distribution of clinical trial materials. The Network consists of wholly Fisher owned facilities and 3rd Party contract depots. The job holder is responsible for the management and oversight of the Quality Management System within the Facility and Depot Network and reports directly to the Quality Director, Facility and Depot Network. To provide direction and support to Facility and Depot Network colleagues on the implementation and application of regulatory requirements, guidelines, global quality assurance policies, and global quality assurance procedures. To monitor and report on the effectiveness of the quality system via an effective Self Inspection and External Auditing system. To monitor and report on the effectiveness of the quality system via an effective Quality Management Review system. To identify improvement opportunities and effectively manage remedial or improvement measures. To liaise with the Quality Director, Facility and Depot Network to ensure that Client requirements are met. Key Responsibilities: Management of the quality management system. Management of the global document control system, including the creation, approval, issue, distribution, and withdrawal of controlled documents. Management and administration of the Trackwise deviation and CAPA system. Ensuring prompt resolution of identified problems via consultation with internal contacts and clients as applicable. Creation, review and approval of associated reports and assigned CAPA's. Performing external quality audits on Third Party Distributors, Fisher Facilities, Service Providers, and Couriers. Completion of associated audit report(s). Liaison with senior personnel within these parties. Issue of CAPA plans and responsibility for the prompt resolution of audit findings. Approval of FCS facilities and 3rd party depots, and maintenance of the approved Facility and Depot List. Monitoring of the quality performance of FCS facilities and 3rd party depots. Preparation and update of Technical Agreements/Quality Agreements. Performing internal audits. Management of the internal audit schedule. Reviewing internal audit findings from each distribution site within the F&D Network and advising local QA on the effectiveness of the local internal audit system. Review and approval of assigned corrective or preventive actions, ensuring timely and satisfactory completion of such actions. Management of the change control system. Review significant change within facilities or depots to ensure compliance with internal and regulatory requirements. Monitor product complaint handling, and if necessary assist in product recall and compilation of associated reports. Monitor and review qualification and validation activities within the Facility and Depot Network. Ensure compliance of such activities to internal and regulatory requirements. Identify training needs and provide the required training materials. Periodic training of staff Produce monthly metrics on assigned global KPI's. Liaise with clients on identified issues and improvement projects. Attend designated client Quarterly Business Reviews (QBR's) to report on Network performance. Monitor the performance of contractors in terms of efficiency, compliance, wastage, and cost. Highlight any potential issues and work to resolve such issues. Liaise with clients on quality related topics and/or issues Collate data for analysis at Quality Management Review Implement and support quality improvement projects within FCS Minimum Requirements/Qualifications: Strong QA and Production experience 5 years experience minimum Commercial mindset. Preferably experience of dealing with contract distributors Good communication skills Good negotiation skills Very good written and spoken English Ability / flexibility to work on a broad range of activities providing hands-on operational support Teamwork / ownership. Desire to play a key role in the management of the business, taking ownership of issues and driving initiatives to build a strong business. Problem Solving/Decision Making Non-Negotiable Hiring Criteria: Strong QA background within Pharmaceutical industry Auditing experience Ability to travel internationally (around 15%)