The Global Quality Systems Manager will be responsible for the development, implementation, coordination, and measurement of Quality Management System processes within the Customer Channels Group (CCG) of Thermo Fisher Scientific.
- Collaborate with global business partners to harmonize and optimize processes and to promote quality, accountability and quality culture.
- Serve as the process owner and subject matter expert for key elements of the Quality Management System, including CAPA, Complaint Handling and Internal Audit, for CCG.
- Facilitate local and global CAPA Management Board meetings to ensure issues are reviewed, actions are completed in a timely manner and escalations are performed, as needed.
- Establish accurate and actionable global metrics to identify areas of risk, assess effectiveness of the Quality Management System, and the communication through Monthly Business Reviews and Quality Management Reviews.
- Conduct regional and global training on key elements of the Quality Management System, including CAPA, Complaint and Internal Audit, for CCG.
- Support the development of requirements, validation and implementation of software solutions to optimize the effectiveness of the Quality Management System.
- Support investigation of significant quality events, including the identification of issues, impact assessment, root cause analysis, oversight of appropriate communication and escalation to senior leadership, as appropriate.
- Become well versed in all aspects of CCG global problem reporting mechanisms, e.g. Complaint Handling, Return Goods Authorization (RGA), Quarantine and Recoveries, Internal and External Audits, Customer Allegiance Score (CAS) Surveys, etc., and support their continuous improvement through the CAPA process and Practical Process Improvement (PPI) Business System.
- Visit suppliers, distribution centers, and customers, as required, to foster quality based thinking throughout the supply chain.
- Maintain appropriate level of expertise in U.S. and international regulatory requirements, policies, and procedures applicable to the processes and systems within the scope of the CCG Quality Management System.
- Execute projects and complete other duties as assigned.
- Experience in leading quality system audits in the Pharmaceutical or medical device industries.
- Experience leading global cross-functional project teams.
- Sound organizational and multi-tasking skills.
- Experience working with customers, suppliers, and senior management.
- Strong computer and analytical skills, including: data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, Data Warehouse tools, Minitab and MasterControl.
- Experience working with a quality information management system, Master Control preferred.
- Practical Process Improvement (PPI) or Six Sigma experience.
- Ability to travel and work in a laboratory, warehouse or manufacturing environment; travel both domestically and internationally approximately 15% of the time.
Non-Negotiable Hiring Criteria: (List 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.)
- Bachelor’s Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics.
- A minimum of 6 years of relevant quality experience within the Pharmaceutical or Medical Device industries.
- Excellent oral and written communication skills.
- Expert at root cause analysis and problem solving with a results orientation.