E-DRUG: StopTB Partnership's Global Drug Facility Job: Product Quality Officer Geneva
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Dear All,
The StopTB Partnership's Global Drug Facility (GDF) is searching for a
Product Quality Officer to be based in Geneva.
The application due date is 31 August 2017.
Please see link (and pasted below) for the job description
https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801 .
Regards,
Brian M. Kaiser MPH PharmD BCPS
Technical Officer, Market Strategies
Background Information - UNOPS
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#0>
UNOPS
UNOPS supports the successful implementation of its partners'
peace building, humanitarian and development projects around the world. Our
mission is to serve people in need by expanding the ability of the United
Nations, governments and other partners to manage projects, infrastructure
and procurement in a sustainable and efficient manner.
Working in some of the world's most challenging environments, our vision is
to advance sustainable implementation practices, always satisfying or
surpassing our partners' expectations.
With over 7,000 personnel spread across 80 countries, UNOPS offers its
partners the logistical, technical and management knowledge they need,
wherever they need it.
A flexible structure and global reach means that we can quickly respond to
our partners' needs, while offering the benefits of economies of scale.
Stop TB Partnership
UNOPS hosts the Stop Tuberculosis Partnership Secretariat (STBP) as of 1
January 2015, in Geneva, Switzerland.
The vision of the Stop TB Partnership is to realize the goal of elimination of
Tuberculosis (TB) as a public health problem and, ultimately, to obtain a world
free of TB by ensuring that every TB patient has access to effective diagnosis,
treatment and cure; stopping transmission of TB; reducing the inequitable social
and economic toll of TB; and developing and implementing new preventive,
diagnostic and therapeutic tools and strategies.
The Stop Partnership is uniquely positioned to support the development and
further implementation by partners of the current and future Global Plan, acting
as a coordinator and catalyst for the range of partners engaged in the fight
against TB.
Founded in 2001, the Stop TB Partnership's mission is to serve every person
who is vulnerable to TB and ensure that high-quality treatment is available
to all who need it. Our partners include international and technical
organizations, government programmes, research and funding agencies,
foundations, NGOs, civil society and community groups and the private sector
As a key initiative of the STBP, the goal of the Global Drug Facility (GDF)
is to facilitate world-wide, equitable access to TB medicines and
diagnostics across both public and private sectors. This goal is achieved
through management and coordination of market activities for the full
portfolio of TB medicines and diagnostics, strategic procurement and
innovative logistics solutions, technical assistance and capacity building
for TB program in better pharmaceutical management practices, and
accelerated uptake of new TB medicines, regimens, and diagnostics using the
GDF 'launch pad'.
The GDF procures all groups of medicines and key diagnostic tools that are
currently recommended by WHO for diagnosis, prevention and treatment of
drug susceptible and resistant forms of TB. When procuring through GDF,
countries are ensured to receive quality-assured TB products in compliance
with WHO Prequalification Program and Stringent National Medicines
Regulatory Authorities or the Global Fund ERP program.
In addition, GDF applies a unique drug monitoring program coordinated with
and performed by contracted Quality control agents which consists of the
review of certificate of analysis for procured products, pre-shipment
inspection of consignments, sampling and quality testing of products
supplied to countries.
GDFs Quality Assurance policy not only ensures supply of quality
medicines, but it also leads to increased overall procurement efficiency
and contributes indirectly to the reduction of delivery lead times.
Functional Responsibilities
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#1>
The Stop TB Partnership is hiring a Product Quality Officer who will work
under the supervision of the Product Quality Lead to ensure that TB
medicines and diagnostics procured and supplied by GDF to countries are
quality assured and of adequate standard.
The Product Quality Officer will be responsible of the following activities:
a) S/he improves the GDF product quality and regulatory related tools,
systems and processes:
- Identify QA issues, challenges and risks, and propose innovative
solutions and optimal risk-mitigation measures
- Develop and maintain excel/access tool that tracks the availability
of valid regulatory and quality documents for importation of TB medicines
and diagnostics, as per the National Regulatory Authorities requirements
- Create a dashboard for rapid tracking and review of product quality
and regulatory documents
- Maintain and improve the standardized excel/access tool for
systematic review of product Certificate of Analysis (CoA) vs approved
pharmacopeia monographs; provide brief analysis of the currently available
results;
- Enhance TB medicines and diagnostics quality complaints management
and its recording and reporting tool.
- Contribute to analytical work on the effectiveness and impact of
GDF QA policy for TB medicines and diagnostics from a product and access
perspective
- Ensure availability of QA training, technical updates, and best
practices sharing sessions
b) S/he stands as GDF QA responsible person for diagnostics:
- Review and update the GDF QA policy for diagnostics
- Establish the GDF quality monitoring program for diagnostics
- Manage and monitor the operationalization and implementation of the
QA policy and quality monitoring program for diagnostics, including quality
testing requirements, selection of quality control agents/laboratories
- Monitor QA status progress for WHO recommended diagnostics
- Act as the quality focal point for GDF diagnostic tenders
- Act as focal point for managing diagnostic quality complaints
- Work in close collaboration with partners, including normative
agencies such as WHO and regulatory authorities, technical partners and
manufacturers.
- Work with partners toward harmonization of QA policy for
diagnostics and approaches to respond to countries program needs for access
to quality-assured diagnostics
c) Assist with developing the GDF online TB products catalogue.
d) Review and maintain up to date the GDF list of quality assurance and
quality control (QA/QC) activities and achievements on the Stop TB /GDF
webpage.
e) Perform other related responsibilities as assigned by GDF Product
Quality Lead.
Monitoring and Project Controls
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#2>
Quarterly reporting on activities and deliverables to GDF Product Quality
Lead for performance monitoring.
Education
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#3>
Advanced university degree (master's or equivalent) in pharmacy,
medicine or public health.
Experience
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#4>
- A minimum of 5 years of professional experience working in quality
assurance for Health Products (in particular for pharmaceutical products
and/or diagnostic products) including in quality control, at national and
international level
- Experience working in international organizations, such as UN
agencies, donors or technical agencies, NGOs and/or private sector
companies
- Experience in developing partnerships with UN agencies, international
NGOs and donors on QA issues
- Experience in developing QA related policies, tools and guidance for
diagnostics
- Experience in Public Health/Procurement and Supply Chain Management
(PSM) of Health Products
- Experience in managing complex situations, issues at country, regional
and international level
- Experience in working in the TB environment, TB medicine or diagnostic
management
Certifications
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#5>
Quality assurance and quality control diploma, especially for
diagnostics, is an asset.
Languages
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#6>
- English and French are the working languages of the United Nations
Secretariat. For this post, fluency in English is required and good
working knowledge of French preferably.
- Working knowledge of other UN official languages is desirable.
Competencies
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#7>
Develops and implements sustainable business strategies, thinks long term
and externally in order to positively shape the organization. Anticipates
and perceives the impact and implications of future decisions and
activities on other parts of the organization.
Treats all individuals with respect; responds sensitively to differences
and encourages others to do the same. Upholds organizational and ethical
norms. Maintains high standards of trustworthiness. Role model for
diversity and inclusion.
Acts as a positive role model contributing to the team spirit. Collaborates
and supports the development of others. *For people managers only:* Acts as
positive leadership role model, motivates, directs and inspires others to
succeed, utilizing appropriate leadership styles.
Demonstrates understanding of the impact of own role on all partners and
always puts the end beneficiary first. Builds and maintains strong external
relationships and is a competent partner for others (if relevant to the
role).
Efficiently establishes an appropriate course of action for self and/or
others to accomplish a goal. Actions lead to total task accomplishment
through concern for quality in all areas. Sees opportunities and takes the
initiative to act on them. Understands that responsible use of resources
maximizes our impact on our beneficiaries.
Open to change and flexible in a fast paced environment. Effectively adapts
own approach to suit changing circumstances or requirements. Reflects on
experiences and modifies own behavior. Performance is consistent, even
under pressure. Always pursues continuous improvements.
Evaluates data and courses of action to reach logical, pragmatic decisions.
Takes an unbiased, rational approach with calculated risks. Applies
innovation and creativity to problem-solving.
Expresses ideas or facts in a clear, concise and open manner. Communication
indicates a consideration for the feelings and needs of others. Actively
listens and proactively shares knowledge. Handles conflict effectively, by
overcoming differences of opinion and finding common ground.
Functional competencies
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#8>
- Understanding of QA matters in the pharmaceutical manufacturing
context and for diagnostics
- Understanding of WHO pre-qualification procedures of medicines and
diagnostics and the assessment/ registration procedures followed by
stringent regulatory authorities, knowledge or understanding of national
regulatory requirements and processes in low and middle income countries
- Understanding of the influence of national and global health policy
issues (in particular those related to QA) on procurement and supply of
pharmaceuticals and diagnostics
- Knowledge of pharmaceutical procurement and supply chain good practices
- Take the lead in solving complex issues.
- Analytical thinking with ability to draw on complex data sources to
provide strategic recommendations.
- Adapt policy and guidance to the reality / context.
- Excellent communication, planning and organizational skills, attention
to detail, ability to multi-task, ability to work effectively under
pressure and meet deadlines
- Cultural sensitivity and integrity.
Additional Considerations
<https://jobs.unops.org/Pages/ViewVacancy/VADetails.aspx?id=12801#9>
- Please note that the closing date is midnight Copenhagen time
- Applications received after the closing date will not be considered.
- Only those candidates that are short-listed for interviews will be
notified.
- Qualified female candidates are strongly encouraged to apply.
- For staff positions only, UNOPS reserves the right to appoint a
candidate at a lower level than the advertised level of the post
- The incumbent is responsible to abide by security policies,
administrative instructions, plans and procedures of the UN Security
Management System and that of UNOPS.
It is the policy of UNOPS to conduct background checks on all potential
recruits/interns. Recruitment/internship in UNOPS is contingent on the
results of such checks.
Brian Kaiser <bkaiserpharm@gmail.com>