Global Quality Systems Manager

2 weeks ago

Pittsburgh, Pennsylvania, United States Thermo Fisher Scientific Full time

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


Key Responsibilities:

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 the effectiveness of the Quality Management System, provide updates during Monthly Business and Quality Management Reviews, and provide trainings on key elements.


Support the identification and development of requirements, validation, and implementation of software solutions to optimize the effectiveness of the Quality Management System.


Support the 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 the use of the CAPA process and Practical Process Improvement (PPI) Business System.



Required Qualifications:
~ Bachelor's Degree in a technical or 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.

Benefits:
We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us.
As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.
Apply today
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