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Compliance Operations Program Manager

US Pharmacopeia
United Statesfull_timeVerifiedPosted 10 Jul 2024

About 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

Support the Global Compliance & Ethics team by contributing to the design and effectiveness of preventative and detective measures to enable proper detection and ongoing review as part of the program. The Compliance Operations PM will collaborate with GCE Leads (including Compliance & Ethics, Trade and DEA Compliance) and other relevant stakeholders to ensure USP’s Global Compliance & Ethics program is aligned with USP’s Code of Ethics and complies with all applicable laws and regulations across jurisdictions.
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 Compliance Operations Program Manager has the following responsibilities:
• Support the development of USP’s overall Compliance & Ethics program, including operational processes and procedures to ensure compliance with applicable laws, regulations, USP’s Code of Ethics and related policies, and industry best practices.
• Assist with the identification, assessment, and communication of compliance program risks and controls including follow-up on management action plans to bridge any gaps identified
• Develop methodologies to track metrics (KPIs) on utilization of a risk and control dashboard
• Make recommendations for and assist in executing process improvements and procedure updates for GCE
• Develop detailed compliance audit/review schedules, to be updated on a quarterly basis, which are consistent with annual system risk matrix and plan
• Support compliance audit/review activity with internal and external auditors
• Draft and maintain relevant documentation and content for changes to the program in accordance with regulatory updates, new business initiatives and overall GCE policies and procedures.
• Take an active role in USP’s investigations process, including conducting investigations and root cause analysis, as well as tracking metrics and reporting to key stakeholders.
Who is USP Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Bachelor’s degree. Four years of experience in a Compliance related role will be considered in lieu of a degree.
• Minimum of six (6) years of experience in Compliance or related field.
Additional Desired Preferences
• Corporate Compliance & Ethics Professional certification (or in-progress certification) preferred.
• Detailed knowledge and understanding of applicable Compliance & Ethics program requirements and best practices and methodologies, including developing policie

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Company

US Pharmacopeia

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