UNICEF Supply Division LTA Roster of Consultants: Medicine Dossier Assessors and GMP/GSDP Auditors, Copenhagen, 3 years, Remote

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For every child, the right to health

1. Background and Purpose

UNICEF Supply Division seeks to establish a roster of pre-qualified external consultants to augment its in-house capacity for (A) technical assessment of medicinal product dossiers ('dossier assessors') and (B) audits against Good Manufacturing Practices (GMP) and Good Storage and Distribution Practices (GSDP) ('auditors'). The roster will also be used to engage experts, under UNICEF supervision to support increasing demand related to UNICEF localization agenda for medicinal products and expanded supply operations in low- and middle-income countries (LMICs).

Quality assurance (QA) is central to UNICEF’s mandate to provide timely access to safe, efficacious, and quality-assured medicines. Robust QA processes—including rigorous technical assessment, GMP audits, GSDP assessments, and quality control—are essential to manage risk, ensure regulatory compliance, and safeguard beneficiaries across global and local supply chains.

2. Objectives and Scope of the Roster

Objectives:

• Establish a pre-qualified pool of dossier assessors and GMP/GSDP auditors with proven regulatory experience and strong reporting discipline.

• Support UNICEF’s localization agenda by strengthening country and regional procurement while upholding global quality assurance norms and standards.

Scope:

• Category A – Medicine Dossier Assessors: technical assessments of medicinal product applications, including administrative, quality (API and FPP), and safety/efficacy, and related capacity-building when requested.

• Category B – GMP/GSDP Auditors: GMP audits of finished medicinal and nutritional product manufacturing sites, sterile API powder for injection (ready to fill) manufacturing sites, and GSDP assessments of warehousing, packaging, distribution facilities and freight forwards.

3. Governance and Supervision

Consultants will work under the supervision of designated UNICEF staff. Roster ownership and day-to-day assignment management will be retained by UNICEF Child Survival Centre (CSC) and Quality Assurance and Policy Centre (QAPC) relevant technical units. For each assignment, UNICEF will designate a UNICEF Supervisor who will approve terms of reference, deliverables, timelines, and payments.

4. Modality of Engagement

Contracting Forms: Individual consultancy contracts.

Work Location: Home-based (remote) and assignments that require travel, subject to UNICEF travel rules.

Time Zone: Collaboration hours aligned to Central European Time (CET) to facilitate interaction with UNICEF Supply Division (Copenhagen).

Roster Duration: Up to three (3) years from selection, with possibility of renewal based on performance and needs.

How can you make a difference?

To qualify as an advocate for every child you will have…

5. Category A – Medicine Dossier Assessors

Key Functions:

• Conduct technical assessments of medicinal product applications in line with UNICEF policies, internal procedures and applicable regulatory guidance.

• Assess administrative sections, Chemistry, Manufacturing and Controls (API and FPP), and safety/efficacy data as applicable.

• Provide written assessment reports with clear queries, conclusions and recommendations

• Contribute to capacity-building when required.

Minimum Qualifications and experience:

• Advanced university degree (Master’s or higher) in Pharmacy, Pharmaceutical Sciences/Regulation or related field with specialization in Chemistry, Manufacturing and Controls (CMC).

• At least 8 years’ progressive experience relevant to pharmaceutical regulation, including hands-on product assessment, at National level. Experience at regional and global level is an added advantage

• Strong knowledge of pharmaceutical markets, regulatory science and procurement interfaces; excellent technical writing in English (additional UN languages are an asset).

6. Category B – GMP/GSDP Auditors

1. Key Functions: Minimum Qualifications and experience for one of the following: The consultant must demonstrate familiarity with WHO, PIC/S, and other stringent regulatory requirements for medicinal products, or demonstrated familiarity against applicable Codex Alimentarius standards and FSSC 22000 for nutrition products. 7. Performance Management and Quality Assurance UNICEF will provide orientation to the consultants, standardized templates/checklists and reporting formats. Each assignment will include quality review of draft outputs and a performance evaluation at closure. Key performance indicators may include time-to-deploy, on-time delivery, quality/completeness of reports, and CAPA closure timelines, as applicable. 8. Indicative Deliverables 9. Remuneration and Travel Remuneration will be commensurate with expertise, experience, assignment complexity, and deliverables. Interested experts should submit expectations for daily rates for information. Travel may be required when authorized, travel will be covered under the contract per UNICEF Procedure on Individual Consultant Contract . Travel plan and budget will be discussed and agreed between the consultant and the Contract Manager before each trip. The consultant must hold a valid travel/medical insurance and comply with BSAFE and applicable inoculation requirements. 10. Eligibility, Confidentiality and Conflict of Interest Eligibility is open to individual experts actively engaged in the regulatory space (National Regulatory Authorities, regional authorities, international organizations, or equivalent). For Medicine Dossier Assessors, the experts must be actively performing full dossier assessments within National Regulatory Authorities or regional regulatory organizations and/or for International organizations such as WHO prequalification programme. All consultants must sign confidentiality undertakings, declare and manage conflicts of interest, and comply with UNICEF’s ethical standards. 11. How to Express Interest Interested experts should submit: (i) a cover letter describing motivation and relevant experience; (ii) a detailed Talent Management System (TMS) profile; and (iii) for auditors, sample redacted inspection/audit reports; iv) a copy of a highest academic qualification and contacts of at least three technical references. Applicants must submit the above documents and complete the online form in the UNICEF Talent Management System, indicating their primary category (A or B). 12. Evaluation and Inclusion in the Roster UNICEF will assess submissions against minimum qualifications, regulatory experience, technical depth, reporting quality, language, availability and references in line with UNICEF HR policies. Pre-qualified experts will be invited to join a three-year roster and may be contracted on a per-assignment basis with specific Terms of Reference outlining the scope and duration of the assignment after confirmation of interest, availability, and the applicable fee. 13. Timeline and Publication Indicative timeline: REOI launch Q2 2026; evaluation and onboarding Q3 2026. The REOI will be published in UNICEF TMS, on appropriate public platforms (GMS) and shared with partner networks. 14. Data Protection and Equal Opportunity UNICEF will process personal data in accordance with its regulations, rules, and policies. UNICEF is committed to diversity and inclusion and encourages applications from all qualified individuals, regardless of gender identity, disability, nationality, religious and ethnic backgrounds. 15. Contact All enquiries should be directed to UNICEF Supply Division – Child Survival Centre (CSC) and Quality Assurance and Policy Centre (QAPC). Please contact Mary Atieno Ojoo, Technical Manager ( mojoo@unicef.org) and Francisco Blanco, Senior Quality Assurance Manager (fblanco@unicef.org). For Every Child, you demonstrate...
   • Plan and conduct GMP audits of finished medicinal product and sterile API powder for injection (ready to fill)manufacturers against applicable WHO GMP guidelines.
   • Plan and conduct GMP audit of manufacturers of nutrition products such as RUTF, LNS, therapeutic milk, High Energy Biscuits and similar products against applicable Codex Alimentarius standards and FSSC 22000.
   • Conduct GSDP audits for warehouses, packaging facilities, distributors and freight forwarders against the applicable WHO GMP guidelines.
   • Prepare audit reports, classify observations, and follow up on the first CAPA received; participate in debriefings and post-audit reviews including documented GMP evaluations.
   • At least 8 years’ proven regulatory inspection experience in GMP of both sterile and non-sterile medicinal finished product manufacturers and/or sterile API powder for injection (ready to fill) manufacturing sites as applicable with audit or inspection training and strong documentation/reporting skills.
   • At least 8 years’ proven regulatory audit experience in GSDP, with audit or inspection training and strong documentation/reporting skills.
   • Experience with auditing of low-moisture and specialized food products required for relevant audits with audit or inspection training and strong documentation/reporting skills.
   • Audit plan (as applicable).
   • Completed assessment/audit report using UNICEF templates, with observations, risk rating/classification, and recommendations.
   • Consolidated assessment/ CAPA follow-up report to closure/ documented GMP/GSDP evaluation.(where assigned).

UNICEF’s Core Values of Care, Respect, Integrity, Trust and Accountability and Sustainability (CRITAS) underpin everything we do and how we do it. Get acquainted with Our Values Charter: UNICEF Values

The UNICEF competencies required for this post are…

(1) Builds and maintains partnerships

(2) Demonstrates self-awareness and ethical awareness

(3) Drive to achieve results for impact

(4) Innovates and embraces change

(5) Manages ambiguity and complexity

(6) Thinks and acts strategically

(7) Works collaboratively with others

Familiarize yourself with our competency framework and its different levels.

UNICEF promotes and advocates for the protection of the rights of every child, everywhere, in everything it does and is mandated to support the realization of the rights of every child, including those most disadvantaged, and our global workforce must reflect the diversity of those children. The UNICEF family is committed to include everyone, irrespective of their race/ethnicity, disability, gender identity, sexual orientation, religion, nationality, socio-economic background, minority, or any other status.

UNICEF encourages applications from all qualified candidates, regardless of gender, nationality, religious or ethnic backgrounds, and from people with disabilities, including neurodivergence. We offer a wide range of benefits to our staff, including paid parental leave, breastfeeding breaks and reasonable accommodation for persons with disabilities. UNICEF provides reasonable accommodation throughout the recruitment process. If you require any accommodation, please submit your request through the accessibility email button on the UNICEF Careers webpage Accessibility | UNICEF. Should you be shortlisted, please get in touch with the recruiter directly to share further details, enabling us to make the necessary arrangements in advance.

UNICEF does not hire candidates who are married to children (persons under 18). UNICEF has a zero-tolerance policy on conduct that is incompatible with the aims and objectives of the United Nations and UNICEF, including sexual exploitation and abuse, sexual harassment, abuse of authority and discrimination based on gender, nationality, age, race, sexual orientation, religious or ethnic background or disabilities. UNICEF is committed to promote the protection and safeguarding of all children. All selected candidates will, therefore, undergo rigorous reference and background checks, and will be expected to adhere to these standards and principles. Background checks will include the verification of academic credential(s) and employment history. Selected candidates may be required to provide additional information to conduct a background check, and selected candidates with disabilities may be requested to submit supporting documentation in relation to their disability confidentially.

Remarks:

As per Article 101, paragraph 3, of the Charter of the United Nations, the paramount consideration in the employment of the staff is the necessity of securing the highest standards of efficiency, competence, and integrity.

UNICEF is committed to fostering an inclusive, representative, and welcoming workforce. For this position, eligible and suitable candidate are encouraged to apply.

Government employees who are considered for employment with UNICEF are normally required to resign from their government positions before taking up an assignment with UNICEF. UNICEF reserves the right to withdraw an offer of appointment, without compensation, if a visa or medical clearance is not obtained, or necessary inoculation requirements are not met, within a reasonable period for any reason.

UNICEF does not charge a processing fee at any stage of its recruitment, selection, and hiring processes (i.e., application stage, interview stage, validation stage, or appointment and training). UNICEF will not ask for applicants’ bank account information.

Humanitarian action is a cross-cutting priority within UNICEF’s Strategic Plan. UNICEF is committed to stay and deliver in humanitarian contexts. Therefore, all staff, at all levels across all functional areas, can be called upon to be deployed to support humanitarian response, contributing to both strengthening resilience of communities and capacity of national authorities.

Additional information about working for UNICEF can be found here.