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Compliance Operations Program Manager

2 months ago

Rockville, Maryland, United States United States Pharmacopeia Full time

Description

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 workan 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 USPs Global Compliance & Ethics program is aligned with USPs 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 USPs overall Compliance & Ethics program, including operational processes and procedures to ensure compliance with applicable laws, regulations, USPs 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 USPs 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:

Bachelors 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 policies and procedures, employee training and communication, risk assessments, and monitoring and testing activities

Diverse experience designing, implementing, integrating, and supporting a compliance program

Ability to think innovatively, influence others, resolve matters effectively and efficiently, and build collaborative relationships with the internal stakeholders, including HR, line of business operations, and all levels of management.

Supervisory Responsibilities

None.

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off, and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR c)

Job Category Legal

Job Type Full-Time