U.S. Pharmacopeial Convention Jobs

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The U.S. Pharmacopeial Convention (USP) Senior Compliance Manager in Rockville, Maryland

Senior Compliance Manager

Quality Assurance/Compliance

Rockville, MD

ID:1719-679

Full-Time/Regular

Summary of the Position

The Senior Compliance Manager is responsible for leading an effective, best practices compliance and ethics culture at USP. The incumbent will assure compliance with local and global laws, regulations, and company policies with a focus on matters relating to fraud and abuse laws, conflicts of interest, federal grant compliance, state and federal transparency requirements, anti-corruption/anti-bribery, and third-party risk management. This global role requires implementation of a program strategy that incorporates the coordination of compliance elements that span across several USP functions and regions and requires seasoned judgment, diplomacy, and an ability to analyze and solve complex problems and to act as a thought partner and collaborator with business leadership and other internal partners including those in Enterprise Risk Management, Internal Audit/Controls, Legal, Human Resources, and Information Services.

Roles and Responsibilities

  • Coordinates and leads a corporate-wide compliance and ethics program that is consistent with USP’s mission, vision and values.

  • Supports leadership to ensure that the organization adheres to industry best practices, including state, federal and international fraud and abuse laws, federal grant compliance, Uniform Guidance (UG) covering federal grant requirements, transparency reporting obligations, and privacy regulations, industry codes in relevant markets, FCPA, anti-bribery laws, supply chain and others, in order to implement improvements to the compliance framework and programs to achieve greater efficiency and effectiveness.

  • Provides oversight, review, guidance and investigation, as necessary, of enhanced due diligence requirements associated with the PQM+ (Promoting Quality Medicine) program and other government funded programs

  • Periodically reviews and coordinates the policies in USP’s Code of Ethics and ensures that appropriate compliance policies and procedures are adopted, published and explained to employees and other relevant stakeholders.

  • Acts as an advocate and champion of the compliance and ethics program among managers and staff through training, day-to-day advice, and guidance on compliance and ethics matters.

  • Works with international sites to implement and maintain the compliance program at each site by providing guidance, ongoing support and training, with visits to each site and periodic assessments, as appropriate.

  • Coordinates with other domestic and international departments and business units to conduct regulatory risk assessments, develop priorities for the global compliance and ethics program, and take actions necessary to resolve potential compliance issues.

  • Conducts or coordinates investigations as requested by Legal.

  • Actively supports the governance dimension of compliance program; prepares governance reports for senior leaders, Ethics and Compliance Committee, senior leaders, and Board of Directors, as needed.

  • Ensures there is a system of auditing and monitoring the compliance program’s effectiveness and USP’s compliance with legal and ethical standards. Ensures that all findings of misconduct and/or weaknesses in the compliance and ethics program are responded to, or escalated to management, promptly and effectively.

  • Gathers, reviews, and analyzes information to identify compliance related trends, patterns, and risk indicators and advise on appropriate mitigation strategies.

  • Works effectively with other USP teams (Legal, HR, Finance, Sales, Marketing, Purchasing, etc.) to identify current and prospective ethics and compliance risks and help to enhance procedures to enable USP to effectively manage those risks.

  • Regularly communicates compliance monitoring results to business process owners and senior management.

  • Provides support for day-to-day compliance or ethics related questions and issues.

  • Assists USP’s leaders to continue to embed a culture of compliance and ethics including training on and reinforcing employee and business partner awareness regarding the risks associated with illegal, unethical, or improper conduct.

Basic Qualifications

  • Bachelor’s degree required

  • Eight (8) years progressive compliance experience, (or 7 years compliance experience and Certified Compliance and Ethics Professional (CCEP) certification)

  • Three (3) years compliance experience at an international or multinational business organization

  • Demonstrated expertise in the following areas: Anti-Corruption, Anti-Bribery, Anti-Money Laundering regulations; government enforcement actions; voluntary/mandatory disclosures; supply chain compliance; managing conflicts of interest; compliance with US Government enhanced due diligence requirements; and Federal Grant Compliance including in-depth knowledge and experience with Uniform Guidance (UG) covering federal grant requirements.

Preferred Qualifications

  • Juris Doctor from ABA accredited law school preferred

  • Knowledge of relevant laws and regulations and experience advising organizations on compliance and regulatory matters, along with expertise in setting up and managing best practices compliance and ethics programs.

  • Demonstrated leadership in working within an organization to implement and maintain a comprehensive program designed to ensure compliance and ethics.

  • Ability to solve complex problems and to communicate complex issues clearly and concisely, with excellent verbal and written communication skills. Includes an understanding of business goals and objectives and sound practical judgment in developing compliance solutions.

  • Demonstrated ability to build strong, credible working relationships cross-functionally, including well-developed interpersonal skills and ability to gain support of and positively influence others’ behavior.

  • Demonstrated ability to communicate and interface with regulators and other third parties, and diverse audiences at all levels of the organization.

  • Demonstrated solid independent thinking and decision-making ability along with ability to discern and understand multiple and competing viewpoints.

  • Intellectual flexibility – adept at reassessing priorities to ensure that internal and external expectations are fulfilled.

  • Strong ability to navigate through barriers to drive successful initiatives throughout the business.

  • Maturity and decisiveness, including the ability to frame issues to support quick decision making as well as an understanding of business in order to know how and when to escalate issues.

Supervisory Responsibilities

None

USP offers an impressive benefits package , including:

  • Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start

  • An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately

  • Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

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.

Job Category Quality Assurance/Compliance

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