Recrutement de 01 Quality Manager, Responsible Person – Medical Services

JOB TITLE: Quality Manager, Responsible Person – Medical Services
TEAM/PROGRAMME:
Global Medical Team /
International Programs LOCATION: London
up to 10% of international travel

GRADE: C Mid-Senior level Type of Contract: Permanent
CHILD SAFEGUARDING:

Level 2: either the post holder will have access to personal data about children and/or young people as part of their work; or the post holder will be working in a ‘regulated’ position (accountant, barrister, solicitor, legal executive); therefore a police check will be required (at ‘standard’ level in the UK or equivalent in other countries).

ROLE PURPOSE:

Save the Children is the world’s leading independent organisation for children, celebrating its 100 years in 2019 as a US$2bn dollar organisation with 25,000 staff in 117 countries – health and nutrition programs being the largest component of its global activity.

One of our 2030 Ambitions is to inspire a breakthrough for child survival – that no child dies from preventable causes before their fifth birthday. This role plays an instrumental role in achieving this breakthrough by contributing to strengthen compliance to safeguard beneficiaries against potential harm from poor sourcing and distribution practices in line with the regulations and the requirements specified for holders of the Wholesale Distribution Authorisation (WDA-H) from the UK Medicines and Healthcare products Regulatory Agency (MHRA).

As a core member of the global medical team and its pharmacy workstream, the Quality Manager, Responsible Person (QM-RP) will provide regulatory oversight to enable compliance with the medical services quality framework in line with the 2022-24 strategy, and contribute to enable safe and quality medical services globally.

The QM-RP will be the named Responsible Person on the WDA(H) licence and ensure that the conditions under which the licence is granted have been, and are being, complied with; and ensure that the quality of medicinal products handled by Save the Children International are being maintained in accordance with the requirements of it’s WDA(H) licence.

SCOPE OF ROLE:

Reports to: Medical Director
Staff reporting to this post: Currently none
Budget Responsibilities: Currently none

Key working relationships: the QM-RP works closely with the Global Pharmacy Advisors and other members of the medical team, the Supply Chain team and across multiple other teams and functions in the organisation such as Operations, Humanitarian, Legal, Safeguarding, HR etc in HQ, regional and country offices, as well as member offices where needed.




KEY AREAS OF ACCOUNTABILITY :

The key areas of accountability will be around enabling safe and quality medical services globally, and will involve the following responsibilities;

Policies, procedures & guidelines (20%):
• Lead on the development and maintenance of procedures, standards and guidelines to enable good distribution practice (GDP) in order to ensure that the provisions of the WDA(H) licence are observed.
• Maintain oversight of and contribute to strengthen the procedures, standards and guidelines of other functions to enable compliance with the requirements of WDA(H).
• Provide recommendations to the Medical Director and senior leadership to inform strategic direction and critical decision-making regarding GDP and regulatory compliance issues.

Practices and compliance (40%):
• Maintain oversight of Save the Children international programme operations in relation to regulatory compliance with WDA(H) requirements;
o ensure the regulatory requirements of the licence are met
o ensure all accountabilities of RP/QM outlined in the Quality Manual are met
o prepare for and coordinate GDP inspections by the MHRA
o carry out regular audits, self-inspections or investigations related to GDP quality assurance and regulatory compliance
o maintain oversight of and manage risks re GDP compliance and patient safety
o essential records and documentation are effectively maintained
o conduct regular reviews with the senior management
o maintain oversight of verification of suppliers and customers, ensuring medicines are only sourced from and supplied to qualified entities
o review and approve quality technical agreements with medical suppliers, logistics providers and sub-contractors
o lead on management of recalls, safe disposal of returned, rejected, recalled or falsified products, and approving any returns to saleable stock
• In collaboration with the global pharmacy advisors;
o lead on effective roll-out of the quality framework and enable operational compliance with pharmacy/GDP procedures, standards and guidelines
o carry out GDP/quality assessments of medical suppliers and contractors, review/input to international tenders and local market assessments
o maintain oversight and management of pharmacy incidents and complaints
o review and provide inputs to strengthen effective end-to-end pharmaceutical management in particular appropriate practices around sourcing (globally and/or locally), transportation and storage of medicines and medical products
• Carry out supportive supervision visits to regional/country offices and conduct safety/quality audits to assess performance and compliance, identifying gaps and support needs, and provide clear recommendations on addressing these.

People empowerment, capacity building (20%):
• In collaboration with the global pharmacy advisors, lead on capacity building of global, regional and country staff to enable good distribution practice.

• Develop and conduct trainings for functional leads and teams, maintaining oversight of cascade trainings across functions to enable compliance with WDA(H) requirements.

• Coach, support and contribute to professional development of SCI/A pharmacy and medical supply chain staff globally.


Partnerships (10%):
• Contribute to strengthen strategic relationships and partnerships to enable safe and quality pharmacy services and compliance with WDA(H) requirements.

• Effectively engage key internal stakeholders and work collaboratively across technical and operational teams across SCI Centre, Regional and Country Offices, and key member offices, to enable GDP compliance.
• Effectively engage key external stakeholders to keep up-to-date with the relevant regulatory requirements, current directives and guidelines.
Publications (10%):
• In collaboration with the global pharmacy advisors, lead on documenting and publishing evidence and learning on GDP and effective pharmaceutical management enabling safe and quality medical services.
• Contribute to the medical team strategic communications and publications, sharing success stories showcasing the safety and quality of pharmacy services.
SKILLS AND BEHAVIOURS (our Values in Practice)

Accountability:
• Holds self accountable for making decisions, managing resources efficiently, achieving results together with children and role modelling Save the Children values
• Holds the team and partners accountable to deliver on their responsibilities - giving them the freedom to deliver in the best way they see fit, providing the necessary development to improve performance and applying appropriate consequences when results are not achieved
• Creates a managerial environment across the Region to lead, enable and maintain our culture of child safeguarding
Ambition:
• Sets ambitious and challenging goals for self and team, takes responsibility for own personal development and encourages team to do the same
• Widely shares their personal vision for Save the Children, engages and motivates others
• Future orientated, thinks strategically and on a global scale
Collaboration:
• Builds and maintains effective relationships, with their team, colleagues, Members, donors and partners
• Values diversity, sees it as a source of competitive strength
• Approachable, good listener, easy to talk to
Creativity:
• Develops and encourages new and innovative solutions
• Willing to take disciplined risks
Integrity:
• Honest, encourages openness and transparency, demonstrates highest levels of integrity
• Always acts in the best interests of children
QUALIFICATIONS AND EXPERIENCE

Essential:
• Meet the RP/QM qualifications and conditions as outlined by the MHRA.
• Experience of enabling regulatory compliance with WDA(H) requirements.
• Experience and understanding of GDP, in particular enabling regulatory compliance, conducting audits, risk management, supplier assessments and managing recalls.
• Experience of working and/or liaising with government drug regulatory authorities.
• Experience of developing/rolling out SOPs and guidelines, and enabling compliance.
• Experience of providing remote support, capacity building and delivering trainings.
• Experience of assuring end-to-end medical supply chain practices, in particular around sourcing, transportation, storage and distribution.
• Proven ability to work with a high degree of flexibility and autonomy, tackling new areas with confidence and leading on engaging stakeholders.
• Excellent planning, organization, problem-solving and influencing skills.
• Excellent written and spoken communication and interpersonal skills in English.
• Cultural awareness and ability to work effectively and collaboratively across diverse teams, functions, offices and organizations.
• High level of computer literacy, including internet and other web-based sources and MS Office suite, incl Excel to analyse and present data
• Ability and willingness to travel, occasionally to insecure locations when needed.
• Commitment to the mission, vision and values of Save the Children
• Permanent residence and right to work in the UK.

Desirable:
• Degree in life sciences, pharmacy or a relevant discipline.
• Experience working in the INGO sector, preferably within large scale medical programmes and/or in emergency response/humanitarian settings.
• Working proficiency in a second language, preferably French, Spanish or Arabic
Additional job responsibilities
The duties and responsibilities as set out above are not exhaustive and the role holder may be required to carry out additional duties within reasonableness of their level of skills and experience.
Equal Opportunities
The role holder is required to carry out the duties in accordance with the SCI Equal Opportunities and Diversity policies and procedures.
Child Safeguarding:
We need to keep children safe so our selection process, which includes rigorous background checks, reflects our commitment to the protection of children from abuse.
Safeguarding our Staff:
The post holder is required to carry out the duties in accordance with the SCI anti-harassment policy.
Health and Safety
The role holder is required to carry out the duties in accordance with SCI Health and Safety policies and procedures.
Date of issue: 25/09/2023 Author: Dr Zaeem Haq