Job Identification : 10796
Locations : Copenhagen, Denmark
Posting Date : 05/19/2023, 08:28 PM
Apply Before : 06/02/2023, 09:00 PM
Job Schedule : Full time
Grade : P4
Vacancy Type : Fixed Term
Rotational/Non Rotational : Non-Rotational
Contract Duration : 1 Year with Possibility for extension
Education and Work Experience : Master’s Degree – 7 year(s) experience
Required Languages : English
Vacancy Timeline : 2 Weeks
Job Category : Management
The Product Quality Assurance Team Lead position is within the Pillar 3 – Quality Management System in the Supply Chain Management Unit (SCMU). You report directly to the Head, Pillar 3 – Quality Management System. You will work closely with the colleagues in SCMU, Technical Division (TD), the Humanitarian Response Division (HRD), the Regional Offices (RO), the Country Offices (CO) and with the Supplier community. The Product Quality Assurance Team is the life force of UNFPA’s supplies, whereby the team ensures that contraceptives, medicines, medical devices, and kits UNFPA deliver to women and girls are safe, effective and will do no harm.
How you can make a difference:
UNFPA occupies a unique position in the Reproductive Health Commodity ecosystem as a critical player in supply chain management, a leading public procurer of reproductive health commodities, a trusted partner to national governments, and one of the few organizations with the scale and partnerships necessary to build accountability for last mile delivery. Additionally, in humanitarian settings, UNFPA is responsible for ensuring the availability of lifesaving sexual and reproductive health and gender-based violence prevention and response commodities to those hardest to reach, and commodities to enable operational programme implementation in the hardest to operate settings.
The Supply Chain Management Unit, which was established in January 2022, ensures that UNFPA is able to support the delivery of life-saving reproductive health products and other programme supplies effectively and efficiently to the end user when and where they are needed. To do so, it provides enabling services to Regional Offices and Country Offices and ensures coordination, end-to-end visibility, and accountability on all supply-chain-management related activities, across all UNFPA Programmes.
As the Product Quality Assurance Team Lead, you will support the Head, Pillar 3 – Quality Management System on the development and implementation of the Quality Assurance framework and policies for the management of sexual reproductive health commodities, lead Quality Assurance activities for the whole of UNFPA, knowledge management, information sharing and manage partners’ relationships for quality assurance of health products, provides technical support to UNFPA Country Offices, Regional and HQ staffs in quality assurance related issues and; support innovation in Quality Assurance.
You would be responsible for:
You will support the Head, Pillar 3 – Quality Management System efforts on:
A. Technical and Quality Assurance substance for supply of Reproductive Health (RH) Medicines, Medical Devices, and Humanitarian Supplies
- Creates awareness and understanding of the need for adequate quality standards of RH medicines, medical devices, and Humanitarian Supplies; best practices, and do-no-harm policies.
- Lead the developments and maintenance of quality assurance/control systems to ensure that ensures that policy guidelines and regulatory requirements are appropriately and consistently applied to UNFPA’s procurement of Reproductive Health Medicines, Medical Devices, and Humanitarian Supplies.
- Represent and position UNFPA in technical fora and groups in meetings on issues such as RH product system strengthening; manages such engagements; serves as liaison between internal stakeholders and external technical groups; keeps internal stakeholders well informed; address gaps and build capacity.
- Oversee the activities of market research, provides analysis, background information, recommendations for improving the suitability and range of products within UNFPA’s catalogue, resulting in more appropriate products, better delivery, and lower costs.
- Contributes to development of supply chain strategies and approaches for Reproductive Health Medicines, Medical devices, and Humanitarian Supplies.
- Support introduction and scaling up of new and/or innovative Reproductive Health Medicines, Medical Devices, and Humanitarian Supplies in programmes. Work closely with TD, HRD and other centres in UNFPA to monitor, evaluate and review how the new products are fit for purpose.
- Work closely with National Regulatory Authorities and other relevant professional organizations to arrange inspections of factories according to the applicable standards and guidelines.
- Lead and provide advisory guidance to the review, updating and establishment of prequalification requirements, guidelines, procedures, and related quality assurance systems for the assessment of factories manufacturing condoms or IUDs, based on existing WHO and UNFPA norms, standards and guidelines and other existing regulatory guidance documents, when appropriate.
- Lead and coordinate the review, updating and establishment of prequalification requirements, guidelines, procedures, and related quality assurance systems for the assessment of factories based on existing WHO and UNFPA norms, standards and guidelines and other existing regulatory guidance documents, when appropriate.
- Coordinate research relevant to the Prequalification scheme, to prepare reports and present feedback, data, and results, including training materials in the areas of work and competence.
- Lead the implementation of a donor-initiated project for quality assurance of RH medicines, medical devices, and Humanitarian Supplies; build and maintain partnerships with Member States, various counterparts, and international partners to implement appropriate interventions on regulation and quality assurance of RH medicines, medical devices, and Humanitarian Supplies.
- Contribute to public health training and workshops.
- Cooperate with the WHO Prequalification Team, International Standards Organisation (ISO) and other relevant stakeholders in relation to RH product standards issues by helping to prepare necessary background materials and briefing notes.
- Ensure the finalisation of required reports on behalf of the Product Quality Assurance Team.
B. Quality control and monitoring of RH Medicines, Medical Devices, and Humanitarian Supplies
- Provide technical oversight to quality control laboratories, testing facilities for the testing of samples and finalization of respective reports.
- Develop quality monitoring systems for RH medicines, medical devices, and Humanitarian Supplies.
- Lead the development and maintenance of quality assurance/control system to ensure that the content of the Laboratory Information Files (LIF) and Standard Operating Procedures (SOP), for laboratories performing quality control analyses of condoms and IUDs is in accordance with the WHO prequalification scheme and UNFPA established norms and standards and internal SOP.
- Provide oversight to the evaluation of the LIFs of laboratories which have expressed an interest in being pre-qualified for the quality control analyses of condoms and IUDs. Organize the assessment and inspection of these laboratories which have applied for prequalification according to the established guidelines and procedures, including finalizing the respective reports.
- Provide technical oversight to quality control analyses of samples of RH medicines, medical devices, and Humanitarian Supplies.
- Liaise with the WHO Prequalification scheme to assist in product testing and laboratory quality control-related issues.
- Liaise with the quality control laboratories that have been assigned to carry out the quality control analyses for the scheme and ensure that high quality reports on the contracted-out work are produced.
- Develop procedures that guide countries for pharmacovigilance of RH medicines, medical devices, and Humanitarian Supplies and recall procedures.
- Lead the implementation of post -market surveillance for RH Medicines, Medical devices, and Humanitarian Supplies
- Be responsible for assuring product quality at the last mile; training for testing laboratories and regulatory bodies; warehouse staff on WHO GDSP etc.
C. Quality Assurance of RH Medicines, Medical Devices, and Humanitarian Supplies
- Institute and maintain a quality assurance system for RH medicines, medical devices, and humanitarian supplies in line with WHO/ISO standards.
- Manage the WHO Expert Review Panel for RH medicines, medical devices, and Humanitarian Supplies.
- Undertake technical assignments on issues related to rational drug use and other pharmaceutical assessment or medical device assessment.
- Provide technical support on contraceptive technology, new developments, issues on quality and safety of innovator and generic RH medicines. Work with WHO and other internal partners on adverse effect management, RH product specific requirements of transportation, and research and development.
- Provide technical support on new health technologies and new developments on medical devices regulation and development.
- Ensure that the content of the Product Dossiers, Standard Technical Documents, and manufacturing practices, for pharmaceutical products and medical devices are in accordance with the WHO prequalification scheme and norms and ISO standards and internal SOP.
- Be responsible for providing oversight to the assessment and inspections of factories of manufacturers RH medicines, medical devices, and Humanitarian Supplies which need quality assessments for UNFPA’s procurement including finalizing the respective reports.
- Be in contact with National Regulatory Authorities and other relevant professional organizations to facilitate procurement and access to RH medicines, medical devices, and Humanitarian Supplies.
- Review and evaluate specifications and safe use of RH medicines, medical devices, and Humanitarian Supplies where necessary.
- Advance the UNFPA agenda on Quality Assurance of RH medicines, medical devices, and Humanitarian Supplies through stakeholder engagement. Partner and collaborate with partners (WHO, UNICEF and other partner agencies).
- Develop training materials and contribute to training workshops organized by WHO and/or UNFPA.
- Develop requirements for storage and transportation of RH medicines, medical devices, and Humanitarian Supplies.
D. Provide technical advisory support to UNFPA Country Offices, Regional and HQ staffs, and partners on quality assurance matters
- Provide advice and guidance to UNFPA staff on issues related to the quality of health products and suppliers.
- Coordinate the identification of quality assurance issues, challenges, and risks and assists in providing constructive solutions including challenges in the handling of the health products at country level (e.g., storage and distribution)
E. Product Quality Assurance team management
- Prepare work plans, identify gaps, and recommend opportunities or required changes to take advantage of new Quality Assurance and regulatory developments and trends.
- Provide managerial responsibility for human, financial and material resources of the team in line with UNFPA and SCMU’s Strategic Plan
- Lead, motivate and develop a team of professionals to enable high performance. Establish and support a learning environment.
- Take responsibility for incorporating gender perspectives in all areas of work, to ensure equal participation of women and men.
F. Carry out any other duties as may be required by UNFPA SCMU leadership
Qualifications and Experience:
- Advanced University degree in Pharmacy, Pharmaceutical Sciences, Biomedical Engineering, Material Science, Medical Laboratory Science/Technology, Nursing, Biomedical Sciences, Public Health or related field is required.
- Completion of relevant training, academic and/or professional certification in Quality Assurance of health products is an asset.
Knowledge and Experience:
- A minimum of 7 years of relevant professional experience (e.g., Public Health Care Services in UN organizations, international NGOs, hospitals, or other high-level health facilities) dealing with regulatory function, product manufacturing, quality assurance and quality control of medical products is required.
- A minimum of 3 years of technical experience working with of RH medicines, medical devices, and Humanitarian Supplies including WHO standards and guidelines, and IMDRF and GHTF standards is required.
- A minimum of 3 years of demonstrated knowledge of international markets (sources, certifications, and controls) is an asset.
- Work experience or support to developing countries is required.
- Experience in supervising a team of personnel in hybrid working is an asset.
- Work experience with the UN or an international organization is an asset.
- Excellent interpersonal, written, and oral communications skills.
Fluency in English is required; knowledge of other official UN languages, preferably French and/or Spanish, is an asset.
- Exemplifying integrity,
- Demonstrating commitment to UNFPA and the UN system,
- Embracing cultural diversity,
- Embracing change
- Achieving results,
- Being accountable,
- Developing and applying professional expertise/business acumen,
- Thinking analytically and strategically,
- Working in teams/managing ourselves and our relationships,
- Communicating for impact
- Effective application of health supply-chain management frameworks, principles, and processes
- Effective management of risks in line with relevant industry standards, frameworks, and processes.
- Ability to analyse issues, applying sound technical principles, data, and informed professional judgement, and to present solution alternatives with a clear articulation of their risks and consequences.
- Ability to communicate effectively in writing and verbally
- Planning and organising
- Strong client service orientation
Compensation and Benefits:
This position offers an attractive remuneration package including a competitive net salary plus health insurance and other benefits as applicable.
UNFPA does not charge any application, processing, training, interviewing, testing or other fee in connection with the application or recruitment process. Fraudulent notices, letters or offers may be submitted to the UNFPA fraud hotline http://www.unfpa.org/help/hotline.cfm
In accordance with the Staff Regulations and Rules of the United Nations, persons applying to posts in the international Professional category, who hold permanent resident status in a country other than their country of nationality, may be required to renounce such status upon their appointment.