Consultancy : Developing UNICEF Framework for Quality Risk Management of Biologicals and biotechnology-derived health products, MNC, Supply Division, Cph

UNICEF Supply Division in Copenhagen is looking for a Consultant to develop the UNICEF Framework for Quality Risk Management of Biologicals and biotechnology-derived health products.

Consultancy: To Develop UNICEF Framework for Quality Risk Management of Biologicals and biotechnology-derived health products

LOCATION/DURATION:

Duration:  Maximum 60 full time equivalent (FTE) working days. The Consultancy contract must be established before the end of 2019 and be completed by 30^th June 2020 at the latest.

Location:

• Majority of the consultancy will be done remotely.
• A proportion of the time to be spent at UNICEF Supply Division, Copenhagen Denmark. Schedule to be determined during inception report.
• Travel: 0-5 days. This may change depending on the evolving needs during the project.

Start Date: 2nd December 2019 (tentative)

Reporting to: Mary Atieno Ojoo, Technical Manager, Medicines and Nutrition Center, UNICEF Supply Division

BACKGROUND:

For more than 70 years, UNICEF has worked with governments and engaged with businesses and partners to develop products and deliver them at scale to improve the health, education and protection of children and their families. UNICEF Supply Division is a major buyer of essential medicines, vaccines and health technologies on behalf of national governments, donors, other UN agencies, and partners.

Because UNICEF supplies are sourced from and delivered to many countries world-wide, including those that may have limited regulatory oversight, for products other than vaccines, UNICEF has its own Quality Management System that includes ensuring compliance with Good manufacturing practices (GMP), product dossier assessment and mitigation of hazards at specific stages of procurement, storage or distribution in the supply chain. UNICEF has a team of experts that perform product assessments and site inspection activities for procurement purposes. Where applicable, UNICEF relies on the Scientific evaluation of health products that are eligible for assessment by the World Health Organization Prequalification programme (http://www.who.int/prequal) and regulatory authorities that apply stringent standards or quality, safety and efficacy (SRAs). (1) 

In recent years, UNICEF’s impact on children’s lives has been enhanced by extending our product portfolio to non-vaccine biologicals and biotechnology derived health products such as biotherapeutics, blood products and in-human diagnostics. In future, we intend to explore engaging in advanced therapies derived from technological advances such as nanotechnologies, gene therapy, cell and tissue engineering.

UNICEF intends to develop a quality framework for biologicals by assessing existing internal and partner quality management systems for these products and defining the UNICEF strategy to ensure quality of biological products procured.

OVERALL OBJECTIVE:

1. To support UNICEF to set up a comprehensive Quality Risk Management System for Biologicals, biotechnology-derived health products and related advanced therapies.

Specific objectives:

1. Document the regulatory frameworks applicable for this product category from High Income Countries, selected Middle Income and selected Low-Middle Income countries (World Bank Classification)
2. Identify and document the gaps and opportunities within UNICEF and broadly in global and local procurement
3. Develop a quality risk assessment strategy for this category of products, for UNICEF only or UNICEF and partners

DESCRIPTION OF ASSIGNMENT

1. Identify and provide an overview of the most important regulatory authorities in biologicals and human biotechnology products by compiling their frameworks, processes and expertise used for pre-approval, approval and post-approval management.
2. Review UNICEF procedures of product assessment/quality assurance of biologicals using 6 families/areas: i) monoclonal antibody products, ii) immunoglobulins, iii) snake anti-venoms, iv) in-vivo diagnostics, v) Insulin and Oxytocin, and vi) non-WHO prequalified vaccines.
3. Gather insight in strategies of partner organizations; describe product assessment procedures of UN agencies and other agencies/organizations that procure or plan to procure biologicals such as ICRC, MSF, PAHO, UNDP, UNFPA, WHO, major government procurers in HIC, MIC and LMIC (TBD). Include indication/expectation about their future strategies.
4. Identify and document gaps and limitations of UNICEFs QMS for these products.
5. Identify and describe quality risk management strategies that could be established by UNICEF including with partners.
1. Based on information gathered, perform SWOTs for the strategies and the different stakeholders performing quality assessment of biologicals. This should include institutions that could provide all or part of the services that UNICEF needs.
2. Describe required expertise (and potential sources) for UNICEF to implement proposed quality risk management strategies.
3. Describe partnering strategies and tactics.
6. Provide final advice/recommendation.
7. Present milestones & outputs internally and externally at intervals  agreed at inception meeting.
8. Organize a stakeholder meeting to share outcome and discuss way forward.
9. The assignment may require additional travel/missions to partner organization depending on the needs during the project as assigned by UNICEF supervisor.

KEY DELIVERABLES; propose your estimated duration and deadline

QUALIFICATION REQUIREMENTS:

Education:

Advanced university degree in one or more of the following areas: pharmacy, chemistry, biochemistry or other life sciences relevant to the pharmaceutical quality of medicinal products.

Work Experience:

• Minimum 8 years of professional work experience relevant to scientific, regulatory and quality assessments of vaccines, biotherapeutics, in-human/vivo diagnostics and blood products
• Project management experience
• Specific experience in Research and Development or Chemistry, Manufacturing and Controls (CMC) or regulation of biological and human biotechnology products is an added advantage

Technical Competencies and Expertise:

• Knowledge and understanding of global norms and standards for biological and biotechnology derived products, including WHO prequalification processes.
• Knowledge and understanding of quality risk management
• Have relevant professional networks including global regulatory stakeholders (WHO, PAHO, EMA, FDA)
• Ability to critically analyze and synthesize information
• Knowledge of technological advances associated with advanced therapies such as stem cells, gene therapy, tissue engineering, nanotechnologies and process analytical technologies

Competencies:

1)   Core Values

• Commitment
• Diversity and Inclusion
• Integrity

2)  Core Competencies

• Communication 
• Drive for Result
• Working with People

3)  Key Functional Competencies

• Applying Technical Expertise
• Analyzing
• Relating and Networking
• Deciding and Initiating Actions
• Planning and Organizing

Language:

Fluency in spoken and written English is required.

Fluency in another UN language e.g. French, Spanish is an asset.

Qualified candidates are requested to submit:

• Cover letter/application.
• Financial quote at a daily rate in US Dollars excluding all taxes.
• CV.
• At least one example of previous, relevant work.
• Brief proposal on how to accomplish the consultancy.
• At least 2 References
• P 11 form (which can be downloaded from our website at http://www.unicef.org/about/employ/index_53129.html). 

Applications are to be submitted through UNICEF's online recruitment system by Friday 8^th November 2019. Please indicate your availability and daily rate to undertake the terms of reference above.  Applications submitted without a daily rate will not be considered.

UNICEF considers best value for money as criteria for evaluating potential candidates.  As a general principle, the fees payable to a consultant or individual contractor follow the “best value for money” principle, i.e., achieving the desired outcome at the lowest possible fee.  Please note that consultants and individual contractors are responsible for assuming costs for obtaining visas and travel insurance.

Successful applicants will be invited to a telephone interview and will be evaluated by the following criteria, in addition to assessment of qualification requirements.