Principal Technical Manager (853-679)
This is a non-supervisory technical position that works as part of a team to help design and manage the implementation of specific pharmaceutical quality assurance/quality control interventions under USP's United States Agency for International Development (USAID) Cooperative Agreement for Promoting the Quality of Medicines (PQM) program. Specifically, the Principal Technical Manager is responsible for backstopping PQM Deputy Director (Technical Support) and support technical implementation of multiple concurrent core/country programs projects for timely accomplishment of work plan objectives. S/He leads the deployment of project management tools and resources to enhance the delivery of PQM technical priorities identified by the Deputy Director, Technical Support. The Principal Technical Manager has both technical and project management roles, and will serve as a liaison between the PQM Technical Support Team (TST) and the Country and Core Program (CCP) Team. Incumbent will leverage his/her background in pharmaceutical quality assurance/quality control, and medicines regulatory and cGMPs to supports the development and implementation of projects.
Roles and Responsibilities:
- Provides technical support in ensuring technical managers (in Manufacturing, Laboratory, and Regulatory Affairs) and the entire technical services team have additional guidance to effectively implement technical activities.
- In close collaboration with technical and program staff, operations team, provide technical direction in support of design, development, implementation, and evaluation of work plans to ensure quantity implementation, reporting and the documentation of lesson learned.
- Monitors progress of technical activities in all work plans and provide technical and strategic leadership to guide effective and timely completion of technical activities.
- In coordination with technical managers and core/country managers, lead technical review of PQM work plan activities and help engineer course correction as needed to ensure the quality work plan implementation.
- Under the leadership of deputy director (technical), lead the development of technical approaches, strategies and tools to ensure technical deliverables are of highest quality and are current with international best practices.
- Backstops the deputy director (technical) and provides overarching support to the technical services team working as utility contributor as well as directly managing or implementing activities as needed.
- Drive continuous innovation and improvement of our technical activities and processes to maximize impact.
- Remain informed of current thinking in pharmaceutical regulations and QA/QC and help to identify and anticipate important global health challenges, trends, opportunities, and develop interventions that leverage USP/PQM’s capabilities.
- Develops innovative approaches to collect and use data, and in collaboration with the Technical Team Managers, Core/Country Program Managers, Technical Writer and Knowledge Management Specialist, work to publish articles on topics related to pharmaceutical quality.
- Help to identify and draft key success stories that highlight technical innovations to share with USAID and key partners and stakeholders.
- Performs other duties as assigned.
- Minimum of eight (8) years for Ph.D. (or 10 years for M.S.) of relevant QA/QC and quality experience, preferably in a pharmaceutical or other regulated industry.
- Minimum of 10 years of work experience in the pharmaceutical industry and/or drug regulatory authority or related required.
- At least 8 years of experience in diverse technical areas including pharmaceutical quality assurance/quality control, medicines regulations and pharmaceutical Good Manufacturing Practice (GMP) required.
- Previous experiences managing multiple projects simultaneously, working in multisector environment, and coordination of concurrent priority activities essential.
- At least one (1) year of supervisory experience leading a team of technical staff is preferred, but not required.
- Graduate degree in a health related field required; chemistry, chemical or biological engineering, pharmaceutical sciences, pharmacy, pharmacology, public health, medical science, biology, or related field highly desirable.
- Has knowledge and experience in multiple technical areas including, but not limited to medicines regulations and generic drug development with emphasis on CMC and GMPs.
- Knowledge of quality assurance/quality control of medicines required; understanding of the principles of ISO 17025 and Good laboratory/Good documentation practices, required.
- Knowledge of public health and pharmaceutical issues in developing countries.
- Knowledge of USAID programs and experience implementing activities in the field a plus.
- Knowledge of principles of controlling diseases of priority public health importance is a plus.
- Experience of working with WHO and/or other international organizations is a plus.
- Demonstrated ability to work independently and manage multiple work flows while effectively managing project timelines and deliverable schedules.
- Ability to manage consultants, set realistic priorities, and plan for successful implementation of programs.
- Program management certification is a plus
- Excellent written and verbal communication skills.
- Expertise in options analysis for pharmaceutical quality systems interventions, developing regulatory frameworks, applying risk-based approaches, and guiding the development of strong and sustainable systems
- Demonstrated experience in project management desirable.
- Pharmaceutical industry and/or regulatory agency experience desirable.
- Competence in word processing programs required, additional skills in presentation (PowerPoint) and knowledge of spreadsheet (Excel) programs preferred.
- Excellent interpersonal and organizational skills
- Demonstrated ability to work as part of a team, meet tight deadlines, and handle several tasks simultaneously with minimal supervision.
- Firm understanding and sense of the importance of paying attention to detail.
- Ability to network with professionals from USAID and other international organizations, as well as local in-country representatives and government officials.
- Ability to travel up to 30% time.
- International health or development experience desirable; experience in working with international development organizations lower and middle income countries desired.
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 Location Rockville, Maryland, United States Position Type Full-Time/Regular