Pharmaceutical Quality Officer

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WFP - World Food Programme

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Application deadline 3 years ago: Tuesday 9 Mar 2021 at 23:59 UTC

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WFP seeks candidates of the highest integrity and professionalism who share our humanitarian principles

Selection of staff is made on a competitive basis, and we are committed to promoting diversity and gender balance

Job Title: Pharmaceutical Quality Officer

Type of Contract: Regular Consultant

Division: SCOL Division

Duty Station (City, Country): RBN Addis Ababa, Ethiopia

Duration****: 11 months

BACKGROUND AND PURPOSE OF THE ASSIGNMENT:

As part of the global COVID-19 response, the World Food Programme is operating the supply chain backbone for the humanitarian and health response. COVID-19 has caused global disruptions to the transport systems and links that health and humanitarian responders would normally rely upon to reach affected areas in a crisis. WFP, working closely with the World Health Organization, the UN system, the NGO community and governments, is using its logistics capacity and expertise to step in and provide these services where commercial capacity currently doesn’t exist, ensuring that critical health and humanitarian personnel and cargo can move to where they are needed most.

Health Supply Chains, including cold chains, are also under incredible strain due to global, regional and local transport disruptions. Flight cancellations and trade restrictions by countries, as well as closing borders, have severely constrained access to essential medicines, including vaccines.

As the COVID-19 vaccines become more readily available globally, the world will experience the largest mass vaccination campaign in its history. Delivering a new vaccine will further strain limited cold chain capacities in low-income countries. In these settings, vaccines will have to be stored and transported to remote areas where cold chain challenges persist. As a result of COVID-19, it is anticipated that cold chain capacity needs will demand an increase of at least five to ten times the current level of investment. At this unprecedented scale, the current consortia of global development partners is unlikely to respond adequately.

The world will require a global effort to establish and sustain health supply chains to deliver a COVID-19 vaccine and related cold chain commodities and equipment, at both upstream and downstream levels. This urgent requirement will prompt a re-think of, and introduce new partners to, the current cold chain transportation eco-system.

ACCOUNTABILITIES/RESPONSIBILITIES:

The incumbent will work within the SCOLS team (Supply Chain & Logistics Operations organization), with a direct reporting relationship to a Global Quality lead, and with functional reporting to the local regional or site management (Regional Bureau or UNHRD hub). The incumbent will support regional and local operations to ensure needs and constraints of the field are represented in the development of global quality standards for pharmaceutical supply. The incumbent will be responsible for implementing the global QMS at regional/hub level and for coordinating with downstream supply chains to ensure quality, safety and integrity of medicinal products is maintained. The incumbent will act as a Responsible Person (RP) for GDP as defined in local legislation for pharmaceutical distribution (WHO GDP is the reference in absence of national guidance). The incumbent will represent regional quality at the WFP Quality Council at which senior management reviews quality performance of the supply chain network. The incumbent will be responsible for reporting quality metrics (KPIs) for the region to the global Quality lead for review by the Quality Council.

This role serves as a point of contact for Quality Management, regional supply chain field operations, engineering, regional hubs, in-market operations for guidance on matters related to current GDP, related MoH requirements and decisions on product quality, e.g. resulting from deviations in procedures, or significant changes in operations. The RP at UNHRDs is responsible for quality oversight of day-to-day operations at the hub. The RP at RB and UNHRDs is also responsible for quality oversight of outsourced activities (third party logistics and transport service providers), and, depending on network design, may have responsibility over contracted service providers in other countries in the region. The incumbent will play a key role in ensuring that WFP standards and regulatory quality and compliance standards and guidance are implemented and sustainable. The incumbent will also develop relationships within industry and with health authorities to ensure WFP interests are supported.

The Responsible Person for GDP assists WFP RB/UNHRD in the following manner:

  • Develop and assist in the implementation of product distribution related to WFP quality standards and global level operating procedures.
  • Develop and maintain local SOPs and coordinate with counterparts at other RBs/UNHRDs for the implementation of standard procedures at other sites.
  • Responsible for local actions and MoH interaction in the maintenance of distribution authorisations (e.g. notifications to MoH, GDP inspection readiness and conduct).
  • Assess emerging regulatory guidance in the area of GDP and serialization, in collaboration with the global Quality responsible person.
  • Assist with the implementation of new GDP and serialization or other market specific requirements in the supply chain to maintain compliance.
  • Lead the implementation of WFP quality management system in the region/operations at the UNHRD and provide quality KPIs to the Quality Council as defined in the SOPs.
  • Investigate and provide guidance to WFP management for significant deviations, operational changes, security concerns (product theft, diversion or counterfeiting) in WFP operations.

DELIVERABLES AT THE END OF THE CONTRACT:

  • Local/regional implementation of WFP global quality management system (QMS).
  • Quality management system KPI measurement and dashboard reporting of in-house and 3PL operations, to global Quality lead according to a defined frequency.
  • Develop and implement quality self-audit programmes for the regional and local operations.
  • Ensure (with HR/Training team) the development of, and adherence to, SOP training programmes for assigned staff.
  • Inform WFP global Quality responsible person of significant quality issues, and regulatory changes for specific product or strategic supply chain network decision making.
  • Advise WFP operations on quality systems management practices.
  • Advise through regional self-audit programme that WFP is complaint in all regards to the local GDP guidelines and practice in WFP markets.

QUALIFICATIONS & EXPERIENCE REQUIRED:

Education:

  • University degree from a recognized academic institution in one or more of the following areas is required: pharmacy, chemistry, biology, biochemistry or related subjects relevant to the pharmaceutical quality of medicinal products, or as required by local legislation for the supervision of medicinal product distribution.

Experience:

  • A minimum of 5 years previous experience is required in pharmaceutical distribution or manufacturing, preferably in the quality and/or compliance fields
  • Professional work experience relevant to scientific, regulatory and quality assessments of medicinal products, vaccines, or biotherapeutics.
  • Experience of quality oversight of contractors and service providers.
  • Experience working with humanitarian agencies (e.g. UNICEF, MSF, GAVI).
  • Familiar with health and other regulatory authorities in low-income settings.
  • Project management experience.

Knowledge and Skills:

  • Process, people and technology knowledge on supply chain management, temperature controlled/supply chain technologies.
  • Expertise in analysing qualitative and quantitative data, root cause investigation and quality risk management methodologies, auditing techniques and presenting findings in written reports.
  • Clear communication skills with cross-functional stakeholders.
  • Can work both independently and in a team.
  • Able to influence indirect reports to deliver results.
  • Able to work well in a matrix organization set up and influence key stakeholders.

Integrity/confidentiality.

  • Agility/flexibility.

Language:

  • Fluency in English required, knowledge of other languages relevant to region of operation is an advantage

Terms and Conditions

WFP offers a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

Please visit the following websites for detailed information on working with WFP.

http://www.wfp.org Click on: “Our work” and “Countries” to learn more about WFP’s operations.

Deadline for applications: 09 March 2021

Ref.: VA No. 140036

Qualified female applicants and qualified applicants from developing countries are especially encouraged to apply

WFP has zero tolerance for discrimination and does not discriminate on the basis of HIV/AIDS status

No appointment under any kind of contract will be offered to members of the UN Advisory Committee on Administrative and Budgetary Questions (ACABQ), International Civil Service Commission (ICSC), FAO Finance Committee, WFP External Auditor, WFP Audit Committee, Joint Inspection Unit (JIU) and other similar bodies within the United Nations system with oversight responsibilities over WFP, both during their service and within three years of ceasing that service.

Added 3 years ago - Updated 3 years ago - Source: wfp.org