Project Director Pharmaceutical Stability and Climate Resilience (Hybrid)

**This opportunity is linked to a proposal. Any candidate selections and employment or consulting engagements depend on the contract award. This position is based in the US. Candidates in India may also be considered.**

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with leading authorities in health and science to develop quality standards for medicines dietary supplements and food ingredients. USPs fundamental belief that Equity Excellence manifests in our core value of Passion for Quality as our more than 1300 hardworking professionals across twenty global locations deliver on our mission to strengthen the supply of safe quality medicines and supplements worldwide.

At USP we value inclusivity for all. We recognize the importance of fostering an organizational culture that provides meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build and the conversations we foster we affirm the value of Diversity Equity Inclusion and Belonging in building a world where everyone can be confident of quality in health and healthcare.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of but not limited to race ethnicity physical and mental abilities education religion gender identity and expression life experience sexual orientation country of origin regional differences work experience and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Brief Project Director Overview

The Project Director will lead the implementation of an anticipated multi-country award to investigate and address heat-stability challenges for critical health products under climate-change scenarios. The Project Director will provide strategic leadership technical expertise and complete oversight of program performance including responsibility for the timely delivery of high-quality project deliverables. You will serve as the primary liaison with key stakeholders ensuring synergy with existing programs and initiatives. You will ensure effective delivery across all goals objectives and strategies in compliance with applicable regulations policies and procedures and establish systems that demonstrate program progress and achievements. The Project Director is responsible for directing and supervising the project team by leveraging effective leadership and management skills. This position is contingent on contract award.

How will YOU create impact here at USP

In this role at USP you contribute to USPs public health mission to expand equitable access to high-quality safe medicines and to improve global health through public standards and related addition as part of our commitment to our employees Global People and Culture in partnership with the Equity Office regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to foster an engaged and productive work environment.

The Project Director has the following responsibilities.

• Oversee all technical and management leadership for each project phase: evidence generation solution mapping and innovation advancement.
• Oversee assessment of heat and humidity impacts on health products across their entire lifecycleâ for multiple products and across multiple countries.
• Guide evidence generation with direct linkages to community health impacts and ensure robust research methodologies meet international standards.
• Build and maintain partnerships with country stakeholders including governments community organizations global health agencies and others.
• Provide technical thought leadership and expertise to identify evaluate and prioritize heat-resilient product innovations especially from the Global South and to develop pathways for the scalability and sustainability of interventions.
• Oversee early-stage investments and proof-of-concept pilots.
• Ensure timely development and dissemination of evidence-based knowledge products for global stakeholders.

Who is USP Looking For

The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices ability to quickly build credibility with stakeholders along with the following competencies and experience:

• Advanced degree in Pharmaceutical Sciences Chemistry Public Health or related field.
• 10 years of experience in pharmaceutical stability regulatory compliance and product lifecycle management.
• Proven track record of developing stability testing protocols managing stability data for regulatory submissions and implementing automated systems for stability tracking and analysis
• Proven track record in implementation research and evidence generation for health products
• Deep expertise in pharmaceutical lifecycle management and real-world product performance monitoring
• Proven track record in global health programs and multi-country project leadership.
• Expertise in ICH stability guidelines GMP/cGMP frameworks and analytical methods.
• Strong understanding of climate-related risks to health products and supply chains.
• Experience with consortium management stakeholder engagement and donor-funded projects.
• Working experience in LMICs
• Demonstrated ability to manage large and complex global projects.
• Excellent communication negotiation and cross-cultural collaboration skills.

Additional Desired Preferences

• Advanced degree in Pharmaceutical Sciences Chemistry Public Health or related field.
• Familiarity with Unitaids priority disease areas and decentralized care models

Supervisory Responsibilities

The Project Director will directly oversee and supervise project staff. The number of direct reports is to be determined.

Required Experience:

Director