Director, Global Quality Standards

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
The Director, of Quality Standards leads the Quality and Strategic Activities in the Reference Standard and Documentary Standard Setting process at USP. This position provides global leadership and innovative management of the organization’s quality system through the development, implementation, and monitoring of Quality programs, policies, and procedures.

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 high quality, 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 Director, Global Quality Standards has the following responsibilities:

• Leadership: Lead a team that fosters a culture of continuous improvement and innovation; collaborates and/or leads cross-functionally with business partners to meet organizational goals to advance the reach of USP initiatives and to ensure quality function is integrated throughout the USP products lifecycle

• Reference Standards/Documentary Standards:

o Establish quality policies/procedures for the development of new and existing Reference Standards and Documentary Standards.

o Stay current with technology that benefits the development of Reference Standards and Documentary Standards publications.

o Develop, implement, and monitor compendial and reference standard quality-related activities.

o Proactively identify areas of risk and work with business partners to create solutions that minimize risks.

• Digital Products/Data Quality:

o Collaborate and provide a quality assessment based on customer perspective and applicable regulatory requirements for continued development of Digital Publications (USP-NF, FCC, DSC, PF, FCC Forum, etc)

o Stay updated on Data Governance and Data Quality

o Participate and provide input based on quality findings strategies to improve data quality.

o Contribute on data quality thresholds/rules, assessment, resolutions, monitoring, and control.

• Quality Systems:

o Develop, implement, and monitor Quality programs, policies, procedures to ensure compliance with certifications/accreditations and corporate policies.

o Lead teams for complex projects/initiatives across multiple functions and global sites.

o Manage quality-related issues, complaints, deviations, and investigations with appropriate corrective/preventive actions.

o Identify, assess, and develop mitigation strategies to quality-related risks through a robust risk management program.

o Drive continuous improvement initiatives across the organization utilizing quality methodologies to optimize processes and enhance efficiencies.

o Identify and implement quality control gates for digital processes