Global Quality Systems Manager

at  Thermo Fisher Scientific

JOB DESCRIPTION

The Global Quality Systems Manager is responsible for the development, implementation, coordination, and measurement of Quality Management System processes within the Customer Channels Group (CCG) of Thermo Fisher Scientific.

REQUIRED QUALIFICATIONS:

• Bachelor’s Degree technical/scientific field, e.g. engineering, chemistry, biology, or mathematics.
• 8+ years of relevant quality experience within the Pharmaceutical or Medical Device industries.
• Ability to travel and work in a laboratory, warehouse or manufacturing environment; travel both domestically and internationally approximately 15% of the time.
• Strong computer and analytical skills, including: data analysis and reporting using: Microsoft Excel, Access, Word, PowerPoint, Data Warehouse tools, Minitab and MasterControl.

PREFERRED QUALIFICATIONS:

• Experience leading a direct or matrix team of staff that delivers against defined objectives.
• Experience working with a quality information management system, MasterControl preferred.
• Practical Process Improvement (PPI) or Six Sigma experience.
• Validated experience using root cause analysis and problem solving with an orientation for results.
• Experience working with customers, suppliers, and senior management.
• Excellent oral and written communication skills.
• Excellent organizational, interpersonal and time management skills

• Collaborate with global business partners to harmonize and optimize processes and to promote quality, accountability and an engaged quality culture.
• Develop, coach and mentor employees to improve the efficiency and effectiveness of the team.
• Serve as the process owner and champion for key elements of the CCG Quality Management System, including CAPA, Compliant Handling, and Internal Audit.
• Facilitate local and global CAPA Management Board meetings to ensure issues are reviewed, actions are completed in a timely manner and concerns are communicated.
• Establish accurate and actionable global metrics to identify areas of risk.
• Assess effectiveness of the Quality Management System, provide updates during Monthly Business and Quality Management Reviews, and provide trainings on key elements.
• Support identification and 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 awareness to senior leadership.
• Become well versed in all aspects of CCG global problem reporting mechanisms: Complaint Handling, Return Goods Authorization (RGA), Quarantine and Recoveries, Internal and External Audits, Customer Allegiance Score (CAS) Surveys and support continuous improvement through use of the CAPA process and Practical Process Improvement (PPI) Business System.
• Visit suppliers, distribution centers, and customers to ensure that quality-based thinking is cultivated throughout the supply chain.