The U.S. Pharmacopeial Convention (USP) Compendial Integrity Head in Rockville, Maryland
The Compendial Integrity Manager is responsible for designing and implementing a comprehensive program that creates a culture of integrity and that ensures that volunteer processes and behaviors are proactively managed with the ultimate goal of protecting USP’s role and reputation. The incumbent will assure volunteers understand and demonstrate integrity with respect to USP Code of Ethics, Rules and Procedures, processes, and other requirements that address such areas as conflicts of interest, confidentiality, and representation of volunteer status. This role requires implementation of a comprehensive program strategy that addresses numerous elements of integrity, requiring an ability to analyze and solve complex problems, leadership of volunteers who must demonstrate integrity, collaboration with staff who implement and monitor the program, change management across all involved, and strong program management skills that encompass risk and lifecycle management on policy, process, systems, communication, and training.
Roles and Responsibilities
Establish a culture of integrity across USP's standards engagement and development efforts that leads to maximization and protection of USP's established roles and reputation as a trusted standards-setting organization.
Coordinates and leads an integrity program for USP expert volunteers that includes, but is not limited to intake, tracking, monitoring and measurement, reporting, communications, training, and continuous improvement.
Is a key subject matter expert on and supports adherence to processes and policies contained in USP's Code of Ethics; Core Values; Rules and Procedures of the Council of Experts; USP's Diversity, Equity, Inclusion, and Belonging initiatives; and others, with a key focus on Standards of Conduct, in order to implement improvements to achieve greater effectiveness.
Works closely with USP volunteer management, committee management, standards approval, and standards development staff to implement, execute, and improve the program.
Works closely with USP Legal and Global Quality & Compliance staff on appropriate aspects of the program, including investigations, interpretations, auditing, and risk management.
Leads governance of the program, including reporting to staff and volunteer leadership.
Serves as key point of contact for day-to-day questions and issues.
Assists staff and volunteer leaders to continue to embed a culture of compliance including training on and reinforcing awareness regarding the risks associated with noncompliance.
Leads staff Standards of Conduct Team in providing cross-functional management and improvement of the program.
Supports all processes associated with the Rules and Procedures (e.g., management of appeals and postponements, stakeholder engagement, formation of expert bodies)..
Bachelor's degree required in business, science, or other related area
Five (5) years progressive related experience (or equivalent level of experience, education, and certification) in areas related to integrity, ethics and compliance
Demonstrated leadership in working within an organization to implement and maintain a similar program
Demonstrated expertise in conflict-of-interest disclosure and management
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
Juris Doctor from ABA accredited law school preferred
Experience in or with regulated organizations, especially food and drug
Training and/or certification applicable to role
Ability to design and deliver training programs
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.
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.
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP offers an impressive benefits package, including:
Generous paid time off – 15 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.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements 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.
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 contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Professional Programs
Job Type Full-Time