Ongoing Recruitment at US Pharmacopeial Convention (USP)

Reports to: Regional Manager, Africa Programs, USP PQM Rockville MD USA

Summary of the Position

• The Chief of Party-Nigeria is a key management role in the USP PQM program responsible for the in-country management, strategy, development, and implementation of this USAID-funded project in Nigeria, part of a global mechanism for assuring medicines quality in resource-limited settings.
• The Chief of Party will provide overall management, technical leadership, and direction for USP PQM activities.
• He/she shall act as the primary point of contact with the USAID country mission, relevant government agenCies, non-governmental organizations (NGO), and community groups with regard to day-to-day management and implementation;
• The Chief of Party-Nigeria is expected to manage staff and subject matter experts in achieving project results.
• He/she will be responsible for evaluating and documenting progress (activity monitoring reports), managing design and evaluation teams, evaluating activities through consultative meetings and site visits, developing solutions to keep activities on track, and providing overall guidance and direction to the program team in order to achieve agreed targets and long-term strategic objectives.
• The Chief of Party will have overall responsibility for assuring that all assistance provided under the cooperative agreement is technically sound and appropriate for the needs to be addressed.

Roles & Responsibilities

• Assumes responsibility for overall program management of USP PQM and acts as country representative. Provides leadership, oversight, and support to all aspects of the program including medicines quality control.
• Promotes strong relationships with the USAID Country Mission, the government of Nigeria, and other NGOs.
• Responsible for regular liaison with the USAID in-country mission to keep them abreast of progress on the project implementation.
• Drafts work plans, quarterly financial and narrative reports, as well as annual reports and ensures that key documents are submitted in a timely manner and approved by USAID.
• Coordinates the planning and organization of advisory on in country stakeholder group meetings.
• Participates in developing and disseminating information on activities to publicize program achievements and results with stakeholders and concerned communities.
• Works with regional and country program managers to improve regional and country-level capacity for pharmaceutical quality control.
• Participates in the design and implementation of program policies and procedures as well as systems to ensure that the program will meet its objectives and expected results.
• Makes recommendations to increase effectiveness and efficiency of program interventions.
• Works with program managers to ensure that proper messaging is provided in the field to stakeholders about the need for country ownership and leadership to ensure sustainability of program activities.

Minimum Requirements:

• PhD in a relevant field such as pharmacy, chemistry, social research, project management, international development, or international business.
• Ten years of related work experience supervising multiple projects with progressively increasing responsibility in a management position.
• Effective record of building relationships with governmental organizations as well as private and community associations

Knowledge, Skills and Abilities

• Fluency in English
• Demonstrated experience in managing complex programs related to good governance, such as those focusing on public administration, institutional capacity development, rule of law, transparency and accountability and anti-corruption.
• Demonstrated proficiency in human resources and project management, as well as in strategic planning.
• Demonstrated leadership skills in managing complex programs, including multiple program components, relevant budget and personnel management, program planning, monitoring and evaluation, and achieving success in complex environments.
• Demonstrated ability to lead in-country coordination and implementation of the program, including host country government relations, client satisfaction, and integration with other projects. High level of interpersonal and diplomatic skills to maintain ongoing contact with high ranking public sector officials; ability to work effectively with government officials and leaders of civic and community-based organizations, and to build lines of communication and cooperation among them.
• Deep understanding of the political and social context in Nigeria.

Supervisory Responsibilities
Oversees the day-to-day activities of four to seven consultants in Nigeria

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Reports to: Chief of Party, USP PQM Nigeria
Summary of the Position

• The Consultant for Pharmaceutical Gt-1P will support implementation of the USP PQt-1 work plan activities in Nigeria, providing technical assistance in Good Manufacturing Practices (GMP), Good Oinical Practices (GCP), and Good Laboratory Practices (GLP), particularly in guiding local manufacturers of maternal and child health medicines (MCH) to participate in the World Health Organization (WHO) Pre-quatification Programme.
• The Consultant will provide ongoing technical support to local manufacturers on achieving compliance with WHO requirements to submit finished pharmaceutical product dossiers for WHO Pre-qualification status.
• The Consultant must be familiar with both international current G"1P standards and WHO requirements for the pre-qualification of medicines.
• The Consultant will provide high level guidance on all aspects of product development and Common Technical Document (CTD)-forrnat dossier submission, including stability studies, dissolution profiling, and bioequivalence studies, as needed.
• The Consultant will work with local manufacturers and with local contract research organizations(CRO) to support the USP PQM technicalassistance program, financed under USAID.
• The Consultant will also support PQM activities related to The National Agency for Food and Drug Administration and Control (NAFDAC) GMP activities, including laboratory compliance and other regulatory functions.

Roles and Responsibilities

• Provides ongoing GMP technical assistance support to local manufacturers of MCH and other medicines under the USP PQM technical assistanoe program in Nigeria.
• Supports the Chief of Party and staff involved in USP PQM quality assurance and quality control activities in implementing MCH work plan activities.
• Provides technical support to pharmaceutical manufacturers on product development and requirements
• Provides technical assistance to support NAFDAC's laboratory WHO Pre-qualification activities
• Performs other duties as requested

Minimum Qualifications:
Education

• Bachelor's degree in chemistry, pharmacy, or related field; a higher degree will be an advantage.
• Relevant experience in GMP in the pharmaceutical industry or regulatory environments Some experience in the establishing compliance with quality systems within pharmaceutical manufacturing companies.
• Knowledge of and experience with the WHO Pre-qualification of Medicines Programme will be considered a plus
• Experience working within a GMP regulated Quality control laboratory is also a plus

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Reports to: Chief of Party-Nigeria, USP PQM

Summary of the Position

• Under the general supervision of the Chief of Party-Nigeria, the Regulatory Associate Consultant will serve as the technical officer responsible for planning, orcanizinq, monitoring, activities that support PQM's efforts to strengthen medicine regulatory activities of the National Agency for Food and Drug Administration and Control (NAFDAC).
• The Consultant will also support PQM's projects that involve strengthening the regulatory compliance ofthe pharmaceutical manufacturing industry in Nigeria.

Roles and Responsibilities

• Provides technical assistance, as needed, in support of PQM activities to improve medicines quality regulatory activities in Nigeria, with specific work requested by program partners and approved by PQM.
• Provides technical advice to NAFDAC management and staff, particularly on medicines regulation and pharmaceutical product assessment through the PQM program.
• Maintains partnerships to ensure continuity of external technical advice and support, which includes the goal of establishing a forum of experts, and coordinates ongoing activities by major regulatory agencies in Nigeria.
• Manages specific PQM project activities as assigned by the PQM Chief of Party-Nigeria.
• Ensures that all program work for the PQM office is completed by country partners on time and on budget.
• Provides assistance in the formulation of guidelines for medicines regulation to improve the safety and quality of medicines in line with the national regulatory system.
• Prepares quarterly and annual activity reports (through COP) and submits them to USP PQM Headquarters, USAID/Nigeria, and other country partners within the set parameters of the contract.
• Serves as liaison officer to partners and regulatory authorities such as WHO, NAFDAC, Federal Ministry of Health, and others. Performs other duties as requested.

Minimum Requirements
Education

• Bachelor of Science degree in pharmacy or chemistry required

Experience

• Relevant work experience in the food, medicines, or drug regulatory area within the pharmaceutical industry
• Experience in project development and implementation. Relevant work experience within government medicines regulatory agencies a plus

Knowledge, Skills and Abilities

• Knowledge of Nigeria's infrastructure related to medicines regulation and quality assurance and control systems.
• Knowledge of pharmaceutical regulations; familiarity of WHO Pre-qualification Programme or good manufacturing requirements. Excellent verbal and written communication skills.
• Ability to influence without direct authority Results-driven with demonstrated successful outcomes; organized and able to effectively follow up on priority activities.
• Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
• Ability to handle multiple priorities in a fast-paced environment

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Reports to: Chief of Party-Nigeria, USP PQM

Summary of the Position

• The Administrative Support Staff position will provide support to the Chief of Party-Nigeriaon routine office operations and financial monitoring of in-country activities of the USP PQM program in Nigeria.
• In addition, Administrative Support Staff will help the COP and PQt-l technical consultants to arrange meetings with USP PQM partners in Nigeria, review financial/expense reports of PQM partners and the PQM Nigeria team to ensure their comphance with USP and USAID regulations, organize events/training workshops under the program in Nigeria.

Roles and Responsibilties
Works under the direct supervision of the Chief of Party. Provides administrative and office support to the USP PQfvl Nigeria technical team with detailed administrative and secretarial duties as follows:

• Receive, screen, and distribute incoming correspondence
• Take minutes of meetings
• Manage the filing systems (hard copy and electronic)
• Manage, maintain, and share schedules among the USP PQM Nigeria team
• Develop and update a database of partners and donors
• Assist the USP PQM Nigeria team in preparing travel arrangements and obtaining hotel and flight reservations
• Assist in preparing in-country program meetings, workshops, and seminars
• Obtain documents and information from partners, related agencies/institutions
• Collect and collate program updates for proper dissemination
• Contribute to communications on USP PQM activities in Nigeria
• Support the Chief of Party in preparing workplan budgets
• Perform other duties as assigned

Preferred Qualifications:
Education

• Bachelor degree in Administration. A Bachelor of Science degree in any field with experience working in an office administration position may also be considered.    

Experience

• 1-2 years' experience in office administration working with multiple staff

Knowledge, Skills and Abilities

• Strong communication and interpersonal skills
• Computer literate with working knowledge of MS Word, Excel, database management, and internet search
• Excellent spelling and grammar skills. Highly organized with good time management skills, ability to set priorities, and attention to detail. Knowledge of pharmaceutical industry language a plus.