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Quality Assurance Manager

1 month ago

Wayne, Pennsylvania, United States Avantor Full time
The Opportunity:

At Avantor, we recognize the importance of our people in driving our global performance. Our Operations, Lab Services, Sales, and other teams rely on our talent acquisition initiatives to attract, engage, and hire the right talent. Our Quality Assurance & Quality Systems vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits.

The Role:

The Quality Assurance Manager is responsible for ensuring the compliance and continuous improvement of the Avantor Global Quality Management System (GQMS) across all locations. This involves collaborating with a diverse global team to identify, develop, and implement improvements to the GQMS. The successful candidate will act independently to ensure quality processes are compliant, effective, and efficient, resulting in the highest level of customer satisfaction, operational excellence, and associate engagement.

Key Responsibilities:
  • Perform independently as the Global Process Owner (GPO) for components of the QMS (e.g. Complaints, Change Control, CAPA)
  • Provide leadership and domain expertise to advance the compliance and performance of the GQMS, including 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 aligns with organizational performance goals and quality standards
  • Champion the integration of the Avantor Business System (ABS) into the GQMS
  • Coach, train, and monitor the adoption of the GQMS across Avantor locations, ensuring that Avantor GQMS processes 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 stakeholders and user groups
Requirements:
  • Bachelor's degree in Life Science, Engineering, QMS, or related field
  • At least 5 years of experience as a quality professional in 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 Certification
Why Avantor?

At Avantor, we are committed to helping you grow your career through our diverse, equitable, and inclusive culture. We offer learning experiences to support your career growth and success. Join our global team of 14,000+ associates who are passionate about advancing life-changing science. Apply today and see how your contributions can make a difference in the world.