Vice President, Scientific Policy & General Chapters (1115-679)
New and revised standards are the lifeblood of USP: up-to-date documentary and reference standards are core to our scientific relevance and sustainability. Scientific excellence is a critical component of USP’s leadership in global quality.
The Vice President (VP), Scientific Policy & General Chapters , is responsible for developing and executing the organization’s strategy for General Chapters, including the scientific policy on compendial hierarchy and architecture, as well as pharmacopeial collaboration and harmonization.
General Chapters are a critical component of USP’s documentary standards and play a central role in determining its compendial scope and architecture. This position will include oversight over the development of the strategy when and how to develop General Chapters and closely partner with all Science department heads to develop and execute a consistent and transparent hierarchy for Chapters and monographs. Robust stakeholder engagement is critical to the successful acceptance and adoption of standards in this area because of their often broad applicability and impact on stakeholders, such as industry and regulatory agencies.
Similarly, collaboration with other pharmacopeia’s, in particular but not limited to the European and Japanese Pharmacopeia, is important to establish and maintain a global dialogue on the value and role of public quality standards. This includes key objectives with regard to harmonization, either through multilateral discussion groups or meetings, or through bilateral collaborations.
Establishing and, whenever necessary improving, scientific rigor in development, review of compendial documents (chapter, monographs, PF articles, etc.) is essential to deliver on USP’s commitment to provide relevant, impactful and timely standards to improve and protect global public health. This position will have broad responsibility over USP’s internal scientific policy.
The VP establishes and/or maintains key contacts with the pharmaceutical industry and maintains strong working relationships with US and international government agencies, such as the FDA, as well as global Pharmacopeial organizations. The incumbent heads a key unit in the Science Division, and leads a team of scientific leaders. In addition, the VP leads and develops his/her staff through mentoring and coaching to cultivate future science leaders. The VP will also serve as a member of the division’s leadership team.
Roles and Responsibilities:
- Develops and executes a strategy for the scientific policy for compendial hierarchy and architecture to drive the standards development process supporting all of USP’s compendial publications.
- Drives resolution of technical and/or compendial issues related to General Chapters in accordance with the Rules and Procedures of the Council of Experts, USP guidelines, standard operating procedures and other established USP practices.
- Drives the implementation of a common process for standards development to be implemented across General Chapters.
- Establishes and maintains productive relations with the Council of Experts, Expert Committees, Project Teams, and Advisory Panels to ensure the highest quality monographs and reference standards.
- Develops the annual budget for revenue, expenses, and operating change targets for the area of responsibility and ensures adherence to budget. Identifies solutions to budget constraints to ensure goals and objectives are not hindered.
- Collaborates closely with USP’s Science Operations team to help revise or establish new processes and/or process improvement initiatives in areas of interest, and to inform structure, strategy, and activities of USP’s volunteer bodies and governance.
- Drives robust and positive engagement with key stakeholders (e.g. companies, industry associations, regulatory agencies) to ensure acceptance and adoption of critical standards with broad stakeholder impact
- Develops and maintains close relationships between USP, regulatory bodies, stakeholders, and other pharmacopeias.
- Tracks and reports frequently on the status of all department activities.
- Leads and develops staff within the department, encourages professional development by assisting in identifying opportunities for learning and professional growth.
- Key contributor to the overall leadership of the Science Division, closely working with the EVP & CSO to help achieve the division’s mission and objectives.
Ph.D. or equivalent professional degree in a field of chemistry, pharmaceutical science or other relevant scientific field of study
- 12-15 years of pharmaceutical industry experience including a minimum of five years in an executive level position in product development or quality.
- 10 years of people management experience managing and leading a group of senior staff.
- Previous success as an analytical laboratory director, including training and developing subordinates and working with USP tests and standards
Knowledge, Skills and Abilities:
- Demonstrated expertise in pharmaceutical analysis including separation science and other purity-indicating techniques
- Understanding of USP standards-setting processes and compendial terminology
- Knowledge of global pharmaceutical and healthcare industries and related trade associations
- Demonstrated success in a people leadership role. Strong business acumen combined with both management and leadership ability.
- Influential leader with the ability to drive problem resolution, transformation, and organizational change.
- Effective coach and mentor to staff.
- Ability to identify and develop talent.
- Demonstrated stakeholder collaboration experience, with the ability to quickly develop and manage internal and external relationships and contacts.
- Excellent written and verbal communication skills, including ability to develop and deliver presentations to Senior Management and the entire organization.
- Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make strategic recommendations quickly.
- Ability to solve complex problems with keen instincts and organizational experience
- Demonstrated ability to collaborate and align across disciplines and departments
- Demonstrated ability to translate strategy into action
- May require travel to international sites
Director, General Chapters
Senior Manager, Pharmacopeial Collaboration
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.Required Experience Job Location Rockville, Maryland, United States Position Type Full-Time/Regular