Senior Clinical Laboratory Quality Manager - US Pharmacopeia

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 or interest in learning 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

USP offers an impressive benefits package, including:

• Generous paid time off – 15 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.

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)