The Senior Manager, Manufacturing Services is a key management role in the Promoting the Quality of Medicines (PQM) program, a cooperative agreement funded by the U.S. Agency for International Development (USAID) and implemented by the United States Pharmacopeia (USP). This position provides overall technical leadership roles and is accountable for direct management responsibilities for a team of highly experienced Good Manufacturing Practices (GMP) experts to accomplish the objectives of the PQM program in support of the development and manufacturing of quality-assured priority essential medicines for USAID-supported public health programs.
The Senior Manager, Manufacturing Services will be responsible for the management of PQM GMP experts in assisting pharmaceutical companies to meet international quality standards and to compile and submit dossiers to the World Health Organization (WHO) prequalification Program or to stringent regulatory authorities approval. S/he laisses with the PQM Laboratory Services and the Regulatory Systems Strengthening Services teams to provide comprehensive quality assurance and good practices inspection support to PQM’s partners, stakeholders, and clients. The Senior Manager also provides technical supervision and oversight to PQM consultants team, organize and deploy technical support to Core Programs as well as to the PQM field offices. The position seats on the PQM Management team and has extensive people management responsibilities.
Roles and Responsibilities:
- Manages all PQM GMP activities, including supervising and conducting inspections of medicine manufacturer and utilize technical skills to ensure safe, efficient, and GMP compliant manufacturing.
- Supports the development and implementation of strategy for achieving and maintaining cGMP compliance of PQM supported manufacturers.
- Supports the establishment of manufacturing, QA, QC process, and documentation requirements for WHO prequalification and the evaluation of cGMP, QA, and manufacturing records received from manufacturers
- Responsible for managing and mentoring direct reports including performance evaluation activities, recruitment, and professional development.
- Oversees and ensures final evaluation of documents and data received from pharmaceutical, manufacturers to ensure compliance with cGMP principles.
- Works with the Promoting the Quality of Medicines (PQM) staff to expedite and coordinate dossier reviews and possible site visits and audits. Provides leadership, guidance, training, and mentorship for direct reports regarding technical knowledge, work ethic, and attitude.
- Develops appropriate guidelines for conducting cGMP auditing of manufacturing firms and manufacturing ingredients, e.g., pharmaceutical ingredients, raw materials.
- Revises, establishes, and provides guidelines for SOPs pertaining to cGMP and QA compliance.
- Identifies and defines opportunities to improve the GMP quality systems of manufacturers.
- Provides advice and guidance to manufacturers on aspects of cGMP compliance.
- Takes the lead in working with other departments within the organization to solve both technical and process-related issues.
- Assists or conducts GMP training and audits as needed.
- Provide regulatory guidance on strengthening of national regulatory systems through planning, coordinating and conducting gap assessment missions to document the status of regulatory systems for health products.
- Provide regulatory guidance on capacity building and technical support activities to address identified gaps following the bench marking, including technical seminars, workshops and or country/regional training courses.
- Represents USP- PQM strategies and policies related to regulatory system strengthening for the oversight of medical products at National Regulatory Authorities (NRA), national, Regional and international meetings, including international scientific and regulatory conferences.
- Represents PQM at global/regional leadership meetings involving the dissemination of information to stakeholders
- Facilitate strategic partnerships and new opportunities for PQM interventions
- Performs other related duties as assigned.
M.S. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related fields with minimum of 7 years relevant experience in conducting cGMP audit of pharmaceutical companies engaged in the manufacturing of active pharmaceutical ingredients and/or pharmaceutical products. An equivalent combination of education and relevant experience may be considered. The incumbent must have industry and/or regulatory experience in establishing quality systems compliance within pharmaceutical manufacturing companies. Prior supervisory experience managing GMP inspectors and assessors, as well as managing manufacturing inspection programs required. Minimum of 5 years’ experience in direct supervision of a team of professional staff
- Knowledge of drug development, GMP requirements, scale-up and commercialization.
- Understanding of generic pharmaceuticals, including testing and production.
- International health or development experience desirable (WHO, USAID programs); experience in working with international development organizations in lower and middle income countries desired.
- Knowledge of public health and pharmaceutical quality issues in developing countries a plus.
- Knowledge of principles of controlling diseases of priority public health importance (e.g. HIV, TB, and Malaria) is a plus.
- Demonstrated people management skills and experience in supervision, and interpersonal and organizational skills
- Ability to create a team environment among staff located globally. Ability to work with nationals from varied backgrounds and cultures.
- Demonstrated ability to multitask and manage competing priorities with minimal supervision.
- Detail oriented and demonstrated ability for high performance
- Ability to network with professionals e.g. WHO, UNICEF as well as local in-country representatives and government officials.
- Excellent verbal communication skills, written and presentation skills; grant writing experience helpful.
- Excellent computer skills in Microsoft Office, particularly Power point and Excel. Competence in use of MS Office Suite.
- Language skills a plus (English, Spanish, French, Arabic, or Mandarin).
- Ability to travel at least 30% of the time to international locations.
About the Organization
The United States Pharmacopeial (USP) Convention is a non-governmental, nonprofit organization whose mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.