Quality Assurance Specialist (Regulatory) P-4, Supply Division, Copenhagen,Denmark, #18628, Fixed Term Appointment

The incumbent will be responsible for cutting edge technical support and advice in developing, reviewing and/or adopting QA policies around International Product Standards, ISO driven Quality Management Systems and regulatory reliance frameworks of both stringent and maturing regulatory authorities, the latter particularly in areas where UNICEF will be fostering a localization agenda to move manufacturing closer to end-users. The position requires close collaboration with product specialists and procurement teams in UNICEF and in partner organisations, specialised technical working groups and other major stakeholders to harmonize QA policies and provide consistency and commonality in QA methods and requirements. Environmental and Social Sustainability is of growing importance in UNICEF, and a key contribution of this position will be further development and implementation of UNICEF sustainable procurement policies and procedures.

UNICEF works in over 190 countries and territories to save children’s lives, defend their rights, and help them fulfill their potential, from early childhood through adolescence.

At UNICEF, we are committed, passionate, and proud of what we do. Promoting the rights of every child is not just a job – it is a calling.

UNICEF is a place where careers are built: we offer our staff diverse opportunities for personal and professional development that will help them develop a fulfilling career while delivering on a rewarding mission. We pride ourselves on a culture that helps staff thrive, coupled with an attractive compensation and benefits package.

Visit our website to learn more about what we do at UNICEF.

For every child, A Fair Chance

Overall, UNICEF Supply Division (SD) in Copenhagen aims to support the health, education, and well-being of children by ensuring that they have access to the essential quality assured supplies and equipment they need to thrive. The work of this post has a direct impact on these aspirations and contributes to ensuring that the goods and services we procure are quality assured, and that quality concerns are properly addressed and managed as needed. This post will also support the rollout of key UNICEF policies and strategies such as Localization and Sustainability.

How can you make a difference? 

Quality assurance is a vital for maintaining high standards and ensuring that the needs of beneficiaries are met consistently with high quality products and services, whilst at the same time driving a culture of continuous improvement within UNICEF’s supply chains. Ensuring compliance to standards and regulatory requirements are core aspects of quality assurance functions.
Inspections and audits can uncover unanticipated risks, non-conformities and areas needing improvement, allowing UNICEF to address problems before they escalate and overall to improve efficiencies in our dealings with suppliers. Having the capacity to verify adherence to standards and regulatory requirements enhances the credibility of UNICEF supply operations, building trust with partners and stakeholders, and clearly demonstrates our commitment to quality.

This position is embedded in the Quality Assurance Centre (QAC), where teams have core responsibilities around the maintenance of a robust Quality Management System both internally and by our suppliers. UNICEF’s product portfolio is aligned with UNICEF’s programmes that aim to realize the Rights of Children. The scope of products and services covered by this position excludes the QA requirements of vaccines, medicines and therapeutic food products, but includes other health products such as medical equipment, devices and consumables.

The incumbent will be responsible for cutting edge technical support and advice in developing, reviewing and/or adopting QA policies around International Product Standards, ISO driven Quality Management Systems and regulatory reliance frameworks of both stringent and maturing regulatory authorities, the latter particularly in areas where UNICEF will be fostering a localization agenda to move manufacturing closer to end-users. The position requires close collaboration with product specialists and procurement teams in UNICEF and in partner organisations, specialised technical working groups and other major stakeholders to harmonize QA policies and provide consistency and commonality in QA methods and requirements. Environmental and Social Sustainability is of growing importance in UNICEF, and a key contribution of this position will be further development and implementation of UNICEF sustainable procurement policies and procedures.

If you would like to know more about this position, please review the complete Job Description here: 18628 Quality Assurance Regulatory Specialist P4 Sept 2024.docx

Summary of key functions/accountabilities:

1. Acts as lead of the Non-Pharma inspection unit. Supports and supervises staff as per UNICEF HR policies and requirements for staff development. Contributes to the development and implementation of UNICEF organisational strategies, strategic plans, workplans, sets and meets regular office management requirements and reporting.
2. Provides specialised advice and guidance to SD centers, regional and country offices and partners around quality standards and regulatory requirements applicable in the procurement and supply of goods and services (health and non-health related), including standards for packaging and packaging materials. Product portfolios mostly represent UNICEF programmatic needs in water and sanitation and education programmes, health products, including medical equipment and devices, In-Vitro Diagnostics, vector control products such as Malaria nets, among other, but excluding medicines and vaccines.
3. Leads and/or supports as relevant the review, development, implementation and/or maintenance of global and local QA policies based on relevant international standards, regulatory requirements and standards for UNICEF procurement.
4. Oversee quality assurance and quality control of products (excluding pharmaceutical products) either shipped directly to countries from supplier premises or those entering UNICEF global warehouses, analyse and report quality deficiencies and incidents, monitor and manage corrective actions as relevant until closure.
5. Acts as lead auditor of compliance with international quality standards such as requirements for quality management systems and environmental and social governance, medical device quality standards among other. Develop in collaboration with technical specialists in procurement units priorities for physical inspections, plan and perform site visits as relevant, and manage Corrective Actions until closure.
6. Establishes new concepts of quality control such as developing and validating inspection and testing protocols, or agreeing quality standards with stakeholders and partners when needs arise.
7. Represents UNICEF at international meetings, consultations and seminars as agreed with relevant counterparts.
8. Manages and/or contribute to relevant partnerships and projects, support focal points responsible for global partner management, participate in internal and external working groups as needed. Prepares and manages time limited projects to achieve specific QA outcomes as agreed.
9. Any other relevant duties in accordance to the center workplan.

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

Minimum requirements:

Education:

• An advanced university degree in mechanical and/or electrical engineering, natural sciences and/or in in QA discipline is required.
• Specialised training and/or professionally recognised qualifications in Quality Management System 2nd Party Auditing, IRCA registration, or lead auditor qualifications covering ISO 9001, ISO 13485 including MDSAP experience, ISO 14001 and ISO 45001 will be a distinct advantage.
• Auditor or Lead Auditor of SA8000 requirements will be a distinct advantage.

Work Experience:

• Minimum 8 years of progressive and relevant professional experience in quality assurance of consumer goods, equipment, and/or medical devices.
• Experience in interpreting regulatory frameworks and applying related quality standards such as EU Medical Device Regulations, EU IVD Regulations, FDA 510k approvals or other major market clearances by the founding members of the Global Harmonisation Task Force.
• Experience in Quality Management at the managerial level and experience in working for an international organization will be an advantage

Language Requirements: 

• Proficiency in English both written and verbally.  Knowledge of another UN language is an asset.

Desirables:

• Developing country work experience and/or familiarity with emergency.

For every Child, you demonstrate…

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 

(8) Nurtures, leads and manages people 

Familiarize yourself with our competency framework and its different levels.

UNICEF is committed to diversity and inclusion within its workforce, and encourages all candidates, irrespective of gender, nationality, religious or ethnic background, and persons with disabilities, to apply to become a part of the organization. To create a more inclusive workplace, UNICEF offers paid parental leave, breastfeeding breaks, and reasonable accommodation for persons with disabilities. UNICEF strongly encourages the use of flexible working arrangements. Click here to learn more about flexible work arrangements, well-being, and benefits.

According to the UN Convention on the Rights of Persons with Disabilities (UNCRPD), persons with disabilities include those who have long-term physical, mental, intellectual, or sensory impairments which, in interaction with various barriers, may hinder their full and effective participation in society on an equal basis with others. In its Disability Inclusion Policy and Strategy 2022-2030, UNICEF has committed to increase the number of employees with disabilities by 2030. At UNICEF, we provide reasonable accommodation for work-related support requirements of candidates and employees with disabilities. Also, UNICEF has launched a Global Accessibility Helpdesk to strengthen physical and digital accessibility. If you are an applicant with a disability who needs digital accessibility support in completing the online application, please submit your request through the accessibility email button on the UNICEF Careers webpage Accessibility tendersglobal.net UNICEF.

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.

UNICEF appointments are subject to medical clearance.  Issuance of a visa by the host country of the duty station is required for IP positions and will be facilitated by UNICEF. Appointments may also be subject to inoculation (vaccination) requirements, including against SARS-CoV-2 (Covid). Should you be selected for a position with UNICEF, you either must be inoculated as required or receive a medical exemption from the relevant department of the UN. Otherwise, the selection will be canceled.

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’s active commitment to diversity and inclusion is critical to deliver the best results for children. For this position, eligible and suitable underrepresented groups 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.

In this role, you will collaborate with colleagues across multiple locations. For effective collaboration, we encourage flexible working hours that accommodate different time zones while prioritizing staff wellbeing.

All UNICEF positions are advertised, and only shortlisted candidates will be contacted and advance to the next stage of the selection process. An internal candidate performing at the level of the post in the relevant functional area, or an internal/external candidate in the corresponding Talent Group, may be selected, if suitable for the post, without assessment of other candidates.

Additional information about working for UNICEF can be found here.