Job Description
Johnson & Johnson is recruiting for a Quality Manager to be located in Cairo.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
Overall Purpose of Job:
This position serves as a local / cluster leader of quality and compliance and oversees the quality status of all regulated functions in the North-Africa (NAF) LOC (Egypt, Jordan, Libya, Sudan, South-Sudan, Erythrea, Somalia and Ethiopia) with head office in Cairo in Egypt.
The Quality Head is responsible for the implementation and maintenance of a Quality Management System (QMS) for regulated activities in the LOC (pre- and post-marketing) and ensures, in collaboration with the various LOC leads of the regulated functions (e.g., Local Safety Officers (PV), Head of Regulatory, Supply Chain, etc.), that the implementation meets the J&J quality requirements and that all applicable global, regional and local regulations are met in the LOC.
The Quality Head is the first point of contact for quality matters for the Managing director and board of the NAF LOC.
This function assures the quality and compliance of the product and services for the NAF LOC markets
1.1. MAIN ACTIVITIES:
- To define and implement thelocal / cluster quality strategy in line with regional Business Quality strategy and local business strategy including:
o Oversight, monitoring and improvement of the LOC quality and compliance metrics
o Proactively partner with other commercial departments to ensure quality aspects of new launches, delisting and divestures are properly handled.
o Work with functional partners to ensure alignment of business quality initiatives with strategic business direction.
o Identify and sponsor local initiatives/projects to increase compliance and to reduce the cost of non-quality / non-conformance.
o Identify and sponsor local cross-functional / cross-sector leveraging opportunities for J&J.
- To lead and co-ordinate the development and deployment of an effectiveLOC QMS
o Coordinate the establishment and maintenance of the local QMS.
o Contribute to the one QMS at EMEA / WW level for the commercial organisations via providing LOC inputs to regional / global representatives and seeking feedback on project status. In case the Quality Head is the representative he/she actively collects regional feedback and provides updates to BQ EMEA / SLT.
o Ensure local processes are compliant and consistent with applicable J&J policies, global and sector standards, global and regional processes (as applicable) and all applicable global, regional and local regulations.
o Ensure local compliance oversight of the entire organisation, in coordination with the other regulated functions (Regulatory, HCBI, Medial Compliance, Legal, PV).
o Ensure compliance oversight and proper local training for related research activities.
- Responsible to obtain and maintain the required QMScompliance certificates, licenses and quality agreements for the LOC, including:
o Understand, document and explain the legal and quality set-up of the LOC: certificates, delegation of authorities, SLA’s, intra company quality agreements, quality agreements with external parties.
o Set-up effective collaborations with other functional areas such as SC QA, Deliver QA, BRQC, ESIQ and PV to ensure reliable product supply that meets regulations.
4.Accountable for local release if mandatory by local regulations.
5.To be the LOC lead for quality oversight and risk management via:
o Oversight and monitoring of complaints in an LOC.
o Triggering, leading and/or coordinating local, regional or global escalations and recalls regarding, product quality or compliance issues.
o Leading the local Quality System Management Review: Report to the Management Board of the LOC the performance of the QMS and the adequacy of the quality resources.
o Leading / coordinating for auditing and inspection. Ensuring that the LOC quality systems for the commercial organisation are in constant state of readiness for planned and ad hoc audits or inspections.
6.To be the LOC point of contact for quality matters for:
o The Managing Director and Board.
o The leads for the regulated functions.
o All LOC employees involved in GxP quality and compliance activities (including commercial Janssen employees).
o Local Health Authorities, industry groups: Influence, alert and / or analyse current or emerging regulations that impact quality systems.
o External stakeholders such as suppliers, distribution centres, 3PL’s …
- Manage the local / clusterBQ organisation and resources
o Manage the BQ employees reporting in full line (QH: G&O, performance reviews, talent development, succession planning …).
o Involve Regional BQ / BQ EMEA SLT for local hiring and promotion of local BQ employees and contractors.
o Manage the local BQ budget / expenses and obtain the yearly LOC approval of the local BQ budget
- Manage the GMP/GDP and product quality aspects
o Where appropriate, act as ‘Responsible Person’ (or equivalent legal position) as required by regulations/local HA and carry out duties as required.
o Either personally carry out or delegate activities to ensure that product is stored, handled and distributed according to J&J standards and all applicable regulations. Delegation may be to LOC quality people or to Deliver.
o Have oversight of all such activities
o Be responsible for the compliant Complaint Management process and any other activities that ensure Product Quality requirements are met.
Qualifications
- A background of working in pharmaceutical/biotechnology industries with a substantial experience of either Quality Assurance or Process methodologies. At least 10 years’ experience required.
- External Body qualification / Certification as Internal Auditor is preferred
- Fluency in the Arabic and the English language is required
- J&J Organisational awareness including J&J products, J&J culture, J&J IT tools.
- Experience in Quality and Project Management, be an expert in at least one regulated area.
- Knowledge of GMP/GDP regulations and understanding of the importance of this area to the function.
- Business acumen to balance safety, compliance and availability of product for a patient.
- Continuous development into current local and EMEA regulations, guidelines and industry quality standards.
- Excellent interpersonal, collaboration, networking and communication skills, self-motivated, clear thinker.
- Proven ability to prioritize risks and to manage multiple critical issues.
- Relevant university degree or business experience and qualifications in areas applying process methodologies.
- Capable of Analytical thinking and capable of summarising the key elements.
- Ability to leverage across LOC’s in EMEA / WW.
- Computer literate with good knowledge of the quality systems used in an LOC / J&J.
- Open for standardization: regional and local thinking, team player at EMEA level.
- Influence, leadership and ability to effectively operate at executive / board level, including assertiveness in conflict/challenging situations.
The QH should be capable to:
-Handle quality issues constructively with executives (Board members, local Health Authorities) as well as being capable to analyse details and to summarise status and mitigation plans.
-Take decisions, taking into consideration all aspects including regulations, business goals and patient safety. Take risk-based and facts-based decisions. Be a quality and compliance role model for all LOC members; further foster the quality mind set for all LOC activities.
-Prioritise.
-Stabilize during crisis situations.
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