The U.S. Pharmacopeial Convention (USP) Senior Director, Technical PQMPlus in Rockville, Maryland
Summary of the Position
The Senior Director, Technical Programs is a key personnel position and part of the leadership team in the Promoting the Quality of Medicines (PQM) + Program. Besides contributing to the management of the PQM + program, the Senior Director, Technical Programs will provide technical oversight to a global team of about 70 medical products regulatory and quality assurance professionals, experts, and scientists working as staff and consultants in Africa, Asia, and East Europe. The Senior Director, Technical Programs leads engagement with the PQM+ consortium partners in the development and incorporation of partners capabilities and tools into PQM+ work plan activities. This position is key in advancing PQM+’s goals of strengthening regulatory and quality assurance systems including laboratory services, expanding product access and capacity for good manufacturing of medical products, and in institutions and workforce development.
The Senior Director will report to Vice-President/PQM+ Program Director and work in close collaboration with the Deputy Program Director to ensure the timely implementation of workplan activities. The incumbent will also substantively contribute to USAID global health and health systems strategies and activities, by supporting the PQM+ USAID Agreement Officer Representative through the provision of technical briefs and keeping them abreast of recent industry updates impacting priority medical products in low- and middle-income countries.
(S)he is a member of the USP PQM+ leadership team and is instrumental in guiding and executing the PQM+ strategy and implementation.
Roles and Responsibilities
Support the PQM+ Program Director as part of the Leadership Team in the management of the PQM+ program.
Lead the development of technical quality and standards for PQM+ to ensure continuous innovation and improvements in technical offerings
In collaboration with the PQM+ Partners Coordinator and the Director, Technical Operations and Continuous Improvement, lead in the engagement of PQM+ consortium partners in the development and incorporation of partners technical approaches, tools, and expertise into PQM+ work plan activities.
Provides leadership and technical direction to staff, consultant, partners, and in-country stakeholders who interact or contribute to the PQM+ Center of Excellence (COE). Set clear overarching goals and objectives that will cascade down to all Technical COE staff and account for their performance in meeting the PQM+ objectives.
Provides technical oversight and quality control to the PQM+ technical functional teams, including the regulatory and quality assurance systems strengthening including laboratory services, product supply and manufacturing, and workforce capacity development teams.
Provide support to Regional Program Directors and Health Elements teams to define technical priorities, design work plans, and implementation plans for the delivery of technical assistance in support of PQM+ work plan objectives.
Develop, deploy, and advocate for the adoption of technical approaches, trainings materials, tools, and best practice guidelines in regulatory and quality assurance systems strengthening, laboratory services, product access and manufacturing, and workforce development and lead efforts at mainstreaming them within the program.
Manage the provision of technical assistance and support for the implementation of PQM+ approved work plan activities for the global health element/Core programs, regional and country programs.
Lead the implementation of activities with the view to expand technical competencies in the recipient countries, achieve sustainable systems strengthening, and demonstrate connection between systems strengthening and health outcomes.
Provide technical oversight to ensure that all work plans related to the technical support functions are of the required quality, meets USP standards, and advance PQM+ objectives for global leadership in pharmaceutical quality assurance systems strengthening. This includes intensive technical review throughout the work planning period and during its implementation, HQ and field staff technical coaching, mentoring, and capacity building as necessary.
Map the competencies of Technical COE staff and identify areas for expanding competencies to meet PQM+ program needs. Periodically measure the technical competency of staff and develop training needs to fill gaps.
Provide quality assurance and review all communications with USAID or other partners related to the technical support areas for technical accuracy, context, and clarity, as appropriate. Serve as the quality assurance lead for the program deliverables.
Liaises with technical staff and program managers to anticipate and compile information requested by USAID to showcase PQM+ accomplishments externally through various medium to include webinars, newsletters, reports, social media etc.
Support the PQM+ Director in outreach and dissemination of key PQM+ deliverables and best practices to partners and global stakeholders, build effective relationships and communications with WHO, Global Fund, Heads of Regulatory Agencies, and global health partners including USAID, Gates Foundation, World Bank and others.
Serve on the PQM + Leadership Team and collaborate with the Program Director in strategic planning to guide PQM+ program.
Bachelor's degree in Public Health, health policy, or health science required. In addition, strong background in pharmaceutical sciences or related science field preferred
12+ years of relevant experience and a minimum of 7 years successfully managing large USAID global programs or other global health technical assistance, or capacity building initiatives related to regulatory and quality assurance systems in developing countries.
Ability to travel up to 25% time.
Masters degree preferred
Proven track record of building and sustaining partnerships for global health and development.
A proven manager with record of leadership and contributing to management teams, decision‐making, communication, and interpersonal skills.
Demonstrated progression in career with increasing responsibilities.
Good understanding of quality assurance and quality control of pharmaceuticals, and systems thinking.
Understanding of monitoring and evaluation including data use for program optimization.
The ability to work efficiently and independently under pressure.
Knowledge of major global health initiatives, public health issues in developing countries, and the related role of medicines quality assurance required.
Good understanding of regulatory science and expertise in international standards and good practices (GxP), understanding of topical issues in regulatory harmonization and quality assurance.
Knowledge of current Good Manufacturing Practices (cGMP) in the pharmaceutical manufacturing industry and WHO prequalification for API, finished products, and drug quality control laboratories required.
Understanding of pharmaceutical supply including quality control and quality assurance during production, distribution, and storage required.
Supports the implementation of the programs with the view to promote and achieve sustainability; Demonstrates connection between systems strengthening and health outcomes.
Excellent verbal, written and presentation skills. Experience publishing in scientific peer-reviewed literature desirable.
Strong commitment to personal and team accountability.
Ability to build relationships and network with professionals from national and international organizations (such as USAID, PMI, PEPFAR WHO, PAHO, MSH, Global Fund, Global Drug Facility etc.) as well as local in-country representatives and government officials.
Ability to create a team environment among globally located staff.
Ability to work with and manage nationals from varied backgrounds and cultures.
This position will supervise technical directors and multiple managers and staff globally.
The following COVID-19 provisions will apply to selected candidate(s) hired:
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 1 st , 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
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 Technical Programs
Job Type Full-Time