(Senior) Clinical Laboratory Quality Manager

  • Senior-level, Full-time staff position
  • Posted on 21 January 2021

Job Description

This position will support the Global Health Technical Program (GHTP) Department within the United Stated Pharmacopeia (USP)’s Global Health & Manufacturing Services (GHMS) Division in two functions: 1) to design, implement, and successfully manage clinical laboratory programs and 2) to support the Monitoring, Evaluation, and Leaning (MEL) functions of donor and non-donor funded projects. The (Senior) Manager will provide expert knowledge of clinical laboratory quality management principles and practices to the assessment, implementation, quality control, monitoring, and continuous improvements of work processes. The (Senior) Manager will also be supporting the design and implementation of projects’ MEL activities to measure, capture, and analyze data for program and policy decision making at different levels (Global, regional, and country).

The (Senior) Manager will provide technical advice on evidence- based methods and strategies, current practice, and established laboratory and operational standards to ensure quality and rigorous design. He/she will build capacity of in country-level, regional or global laboratory staff and partners. He/she will ensure that program implementation adheres to appropriate laboratory technical standards and guidelines and that programs are technically sound. She/he will provide scientific leadership by staying current of evolving laboratory technical standards, guidelines, and program developments in area of expertise. She/he may be required to coordinate and work with a diverse group of organizations, such as Ministry of Health laboratory staff and leaders and partners, as well as in country donor and stakeholder representatives. This role is planned to be hired out of our Rockville, Maryland Headquarters, but could also be hired from one of our field offices in Kenya, Nigeria, Ghana or Ethiopia if a qualified candidate is located in and a citizen of one of those countries.

Roles and Responsibilities

This position will work closely with laboratory program and MEL staff as well as USP field staff to provide technical expertise in developing, implementing, and monitoring comprehensive quality management system for clinical diagnostics laboratories and MEL activities. Specifically, the key responsibilities by role will include:

Clinical Diagnostics Laboratories (estimated at 60% full-time equivalent):

  • Lead the implementation Quality Systems programs that are consistent with and regulatory policies and standards by providing appropriate guidance and technical support

  • Assist with update, revise, and maintain the Laboratory’s Quality Assurance Manual, Standard Operating Procedures, and other quality documents Audits and reviews quality data according to established procedures

  • Identifies areas for laboratory quality improvement and discusses implementation recommendations with supervisor and relevant laboratory leadership, using the SLIPTA check list

  • Supports corrective action task force initiatives, conducts quality audits and process validation

  • Supports the development of tools for the implementation of clinical laboratory capacity building using the SLMTA program

  • Work with recipient laboratory to develop institutional development plan and mentorship to address gaps and improve patient care

MEL Activities for Global Health Programs (estimated at 40% full-time equivalent):

  • Responsible for capturing and synthesizing data, generating knowledge/evidence and facilitating learning within USP’s Global programs and externally with other stakeholders

  • Provide support in the implementation and management of MEL activities that include consolidation of M&E data for donor-funded funded projects within GHMS Division for quarterly reporting

  • Manage the M&E data collection system (DevResults) to ensure data quality.

  • Assist with refresher trainings of staff on the M&E system

  • Support the development of data collection tools/ procedures/training materials for M&E and learning activities

Basic Qualifications

Manager:

  • Bachelors of Science in medical laboratory technology or an equivalent (biological sciences) with focus on medical microbiology,

  • Five (5) plus years experience in medical microbiology in a human clinical laboratory s with at least two (2) years’ experience in developing countries in a laboratory quality management

Senior Manager:

  • Bachelors of Science in medical laboratory technology or an equivalent (biological sciences) with focus on medical microbiology,

  • Eight (8) plus years experience in medical microbiology in a human clinical laboratory s with at least two (2) years’ experience in developing countries in a laboratory quality management

Skills Sought

  • Knowledge and experience with strengthening laboratories to achieve international quality standards including against ISO/IEC 15189

  • Experience with Monitoring and Evaluation for donor-funded programs especially health systems strengthening projects in LMICs

  • ISO/IEC 15189 or WHO pre qualifications (exposure to WHO SLMTA program and SLIPTA checklist)

  • Strong written and oral communication skills

Preferred Qualifications

  • Master or PhD preferred

  • Strong analytical skills and ability to use data visualization applications to present data

  • Knowledge and experience in the laboratory diagnosis of infectious diseases including specific hands-on laboratory experience

  • Familiarity with international biosafety regulations

  • Fluency in French

  • Ability to travel up to 25% time

About the Organization

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. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. Our programs are focused on building the capacity of regulatory authorities and manufacturers in ensuring patient access to quality-assured essential medicines by providing: 1) technical assistance to manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health (MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products.

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