Avantor
Quality-Assurance-Manager
Avantor, Phila, Pennsylvania, United States,
At Avantor, people are the most important part of our success because they drive our global performance. That's why our Operations, Lab Services, Sales, and many other Avantor teams rely on our talent acquisition initiatives to attract, engage and hire the right talent. Avantor's Quality Assurance & Quality Systems vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits.The Quality Assurance Manager is responsible for the compliance and continuous improvement of the Avantor Global Quality Management System (GQMS) across all locations. The Quality Assurance Manager collaborates with a diverse global team to identify, develop, and implement improvements to the GQMS. They act independently to ensure quality processes are compliant, effective, and efficient to assure the highest level of customer satisfaction, operational excellence, and associate engagement. They lead programs requiring engagement with leaders at all levels of the company (including leaders at the ELT level) and are responsible for deploying Quality processes that balance the needs of government regulations, customer requirements and various internal functions with the strategic direction of the company. This role is crucial for maintaining high standards of quality and compliance, directly supporting Avantor's operational effectiveness and adhering to quality standards and regulatory requirements.This position will report into the Director, Quality Assurance - Post Market and is
REMOTE .What we're looking for:Education:
Bachelor's degree in Life Science, Engineering, QMS, or related field.Experience:
At least 5 years as a quality professional, within a regulated environment.
Knowledge of multiple industry QMS standards: ISO 9001:2015, ISO 13485:2016, AS9100:2015.EU MDR & IVDR, 21CFR820, Compendial Standards, ISO 17025, IPEC, etc.
Preferred Certifications:ASQ Manager of Quality & Operational Excellence CertificationWho you are:Exceptional ability to manage and inspire diverse teams across multiple locations and clearly present complex matters to stakeholders.Skilled in Microsoft Office, Teams, SharePoint and eQMS platforms like EtQ, Master Controls, or TrackWise.Expertise in applying lean methodologies integral to Avantor Business Systems (ABS), including Standard Work, Tiered Daily & Visual Management, Value Stream Mapping, Hoshin Kanri (strategic planning), and Kaizen (continuous improvement).Capable of initiating and leading projects with minimal supervision.How you will thrive and make an impact:Perform independently as the Global Process Owner (GPO) for components of the QMS (e.g. Complaints, Change Control, CAPA)As the GPO provide leadership and domain expertise to advance the compliance and performance of the GQMS. This would include establishing and authoring policies, procedures, governance processes and key performance indicators.Lead programs of significant strategic importance to meet current and future government QMS compliance requirements and customer/industry expectations.Communicate to the Executive Leadership Team (ELT) and other stakeholders on the effectiveness of the GQMS and provide recommendations for improvement and resource needs.Initiate and lead continuous improvement of the GQMS that align with organizational performance goals and quality standards.Champion the integration of the Avantor Business System (ABS) into the GQMSCoach, train, and monitor the adoption of the GQMS across Avantor locations, ensuring that Avantor GQMS process are fully deployed and running effectively and efficiently.Apply Risk Management principles and processes to mitigate risks and ensure the GQMS is scalable for the different business segments and markets Avantor serves.Provide GPO and Subject Matter Expertise (SME) in the readiness, preparation, management and response to inspections and audits at Avantor locations.Cultivate a culture of quality across the Avantor company with a focus on decision making at the appropriate level of the organization and incorporating a data-driven approach.Integrate quality into the broader organization and enable associates to execute quality processes effectively, timely and efficiently.Provide accurate and timely reports to communicate the performance and maturity of the GQMS to different stakeholder and user groups.
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REMOTE .What we're looking for:Education:
Bachelor's degree in Life Science, Engineering, QMS, or related field.Experience:
At least 5 years as a quality professional, within a regulated environment.
Knowledge of multiple industry QMS standards: ISO 9001:2015, ISO 13485:2016, AS9100:2015.EU MDR & IVDR, 21CFR820, Compendial Standards, ISO 17025, IPEC, etc.
Preferred Certifications:ASQ Manager of Quality & Operational Excellence CertificationWho you are:Exceptional ability to manage and inspire diverse teams across multiple locations and clearly present complex matters to stakeholders.Skilled in Microsoft Office, Teams, SharePoint and eQMS platforms like EtQ, Master Controls, or TrackWise.Expertise in applying lean methodologies integral to Avantor Business Systems (ABS), including Standard Work, Tiered Daily & Visual Management, Value Stream Mapping, Hoshin Kanri (strategic planning), and Kaizen (continuous improvement).Capable of initiating and leading projects with minimal supervision.How you will thrive and make an impact:Perform independently as the Global Process Owner (GPO) for components of the QMS (e.g. Complaints, Change Control, CAPA)As the GPO provide leadership and domain expertise to advance the compliance and performance of the GQMS. This would include establishing and authoring policies, procedures, governance processes and key performance indicators.Lead programs of significant strategic importance to meet current and future government QMS compliance requirements and customer/industry expectations.Communicate to the Executive Leadership Team (ELT) and other stakeholders on the effectiveness of the GQMS and provide recommendations for improvement and resource needs.Initiate and lead continuous improvement of the GQMS that align with organizational performance goals and quality standards.Champion the integration of the Avantor Business System (ABS) into the GQMSCoach, train, and monitor the adoption of the GQMS across Avantor locations, ensuring that Avantor GQMS process are fully deployed and running effectively and efficiently.Apply Risk Management principles and processes to mitigate risks and ensure the GQMS is scalable for the different business segments and markets Avantor serves.Provide GPO and Subject Matter Expertise (SME) in the readiness, preparation, management and response to inspections and audits at Avantor locations.Cultivate a culture of quality across the Avantor company with a focus on decision making at the appropriate level of the organization and incorporating a data-driven approach.Integrate quality into the broader organization and enable associates to execute quality processes effectively, timely and efficiently.Provide accurate and timely reports to communicate the performance and maturity of the GQMS to different stakeholder and user groups.
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