Quality Assurance Program Manager
US PharmacopeiaAbout the role
Who is USP?
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our
core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity,
Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Brief Job Overview
This is a hands-on, non-supervisory position in Quality Assurance. This position works collaboratively across multiple departments to lead successful implementation of new operational strategies required to develop physical analytical materials. The incumbent is responsible for developing a Supplier Quality Management program for all third-party suppliers for meet the company’s quality, compliance and performance standards. This position will manage and monitor activities across established producers of USP material to ensure high quality materials and requirements are met. The incumbent will also be responsible for developing and implementing new business processes and solutions to support new business strategies, monitor performance, and measure organization effectiveness.
How will YOU create impact here at USP?
In this role at USP, you contribute to USP's public health mission of increasing equitable access to highquality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with
the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.
The Quality Assurance Program Manager has the following responsibilities:
• Leadership:
o Lead cross-functional teams to establish new business processes and systems required for development of USP physical materials with 3rd party suppliers.
• Supplier Quality Management Program:
o Develop, implement, and monitor the Supplier Quality Management program for custom products outsourced to 3rd party suppliers.
o Evaluate and approve new suppliers based on quality standards, certifications, and production capabilities.
o Conduct supplier audits/assessments to ensure compliance to organizations quality standards and operational expectations.
o Develop Quality Agreements to ensure compliance with quality standards and applicable regulatory requirements.
o Collect, trend, and analyze data to measure supplier performance, identify trends, and measure against quality metrics and Key Performance Indicators (KPI).
• Operational excellence:
o Develop and implement new business processes and solutions to support new business strategies, monitor performance, and measure organization effectiveness.
o Ensures continuous innovation to deliver leading edge and fit for purpose solutions to the organization.
o Track and trend different elements of the quality system and report on the progress of the programs, including areas of strength and opportunities for improvement on a monthly basis.
o Leverage Artificial Intelligence tools to make data-driven decisions, improve efficiencies, streamline processes, and optimize productivity.
• Project management:
o Oversee and execute projects from initiation to completion including planning, coordinating, and ensuring the successful delivery of projects within scope and timeline.
o Effectively communicate project updates and key
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