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The U.S. Pharmacopeial Convention (USP) Senior Technical Advisor, Lab QMS/QA/QC in Rockville, Maryland

Description

Summary of the Position

The Senior Technical Advisor, Laboratory (STAL) QMS/QA/QC will support the PQM+ project within the United States Pharmacopeia (USP)’s Global Health & Manufacturing Services (GHMS) Division in two functions: 1) act as lead technical subject matter expert (SME) in the operational implementation, and continuous improvements of PQM+ laboratory programs across core and country portfolios 2) to support the program implementation monitoring and continuous improvements functions of PQM+ laboratory program by analyzing technical deliverables and using it to design technical innovation and resourcing. The Senior Technical Advisor, Laboratory QMS/QA/QC (STAL) will apply expert knowledge of pharmaceutical laboratory quality management principles, quality assurance and quality control best practices to the assessment, implementation, innovation, monitoring, and continuous improvements of work processes.

The STAL will be the technical point of contact and oversight/leadership on evidence- based methods and strategies, current practices, and established laboratory operational standards to ensure quality and rigor in implementation of PQM+ work plans. He/she will build capacity and mentor in country-level, regional or global laboratory staff and PQM+ partners. He/she will ensure that program implementation adheres to appropriate pharmaceutical laboratory technical standards, tools and guidelines and that work plan activities are technically sound and implemented timely as planned. 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.

Roles and Responsibilities

Technical leadership in the implementation of pharmaceutical laboratory quality management systems, quality assurance and quality control programs that are consistent with national, regional, and global policies and standards by providing appropriate technical guidance, tools, and resources to successfully implement PQM+ work plans.

Act as the technical leader or SME in guiding the development of laboratory program work plans, ensuring consistency and harmonization of laboratory principles, quality by design, and continuous improvements of deliverables across core and country portfolios.

Assist with update, revise, and maintain the PQM+ Short Term Technical Assistance (STTA) Guideline, Standard Operating Procedures, and other quality documents Audits and tools (e.g., SATTA) and reviews quality data according to established procedures for continuous improvements

Supports corrective action task force initiatives, conducts quality audits and process validation towards technical innovation and technical resource allocation

In collaboration with the Director for MEL, review and analyze laboratory program data – deliverables, means of verification, and outcomes – and use the results to recommend improvements in quality assurance of PQM+ technical activities.

Contributes to the PQM+ systems-based approach in designing, developing, and providing technical assistance in the area of laboratory improvements at the country and regional level

Leads in developing training content, delivery and reporting of technical assistance (TA) in quality management systems (QMS), according to ISO/IEC 17025 or similar to ensure standardization and harmonization of training materials.

Serves as a technical resource among the PQM+ technical staff with respect to laboratory quality assurance and quality management activities.

Contributes to the PQM+ Center of Excellence in developing and disseminating PQM+ approach documents related to quality assurance/quality control

Provides inputs in the development of PQM+ technical approach and tools in line with PQM+ and global laboratory strategies

Basic Qualifications

Bachelor’s degree in regulatory affairs, pharmacy, public health, pharmaceutical science, chemistry, engineering, or related field

Eight (8) years’ experiences in pharmaceutical laboratory

Skills Sought

Lab experience of the nature of ISO or WHO prequalified laboratory in regulatory agency, private sector manufacturing laboratory or similar in low- and middle-income countries

Hands on experience in development and implementation of laboratory quality management systems according to ISO/IEC 17025 or similar programs

Understanding of Laboratory accreditation and competency needs according to US FDA, WHO prequalification program (PQP), ISO, or similar certification programs

Understanding of the norms and practices of pharmaceutical laboratory systems strengthening

Willingness to travel at least 25% of the time.

Preferred Qualifications

Strong written (especially technical writing) and oral communication skills with proven publication or lessons learned and/or abstract at international conference

Direct experience implementing USAID-funded programs

Demonstrated experience working in key functions in a national quality control laboratory (NQCL) or organization providing technical assistance to strengthen medicines quality assurance systems

Deep understanding of the WHO’s Laboratory Competency Framework and the Global Benchmarking Tool

Three (3) years of experience in people management at national or global level with proven expertise in managing/leading technical teams

Supervisory Responsibilities

None but functional guidance to Regional QA/QC Advisors – Africa and Asia

COVID-19 Provisions

The following COVID-19 provisions will apply to selected candidate(s) hired:

As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1 st , 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

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)

Job Category Technical Programs

Job Type Full-Time

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