J&J Family of Companies Business Quality Executive in Cairo, Egypt

Johnson & Johnson

Johnson & Johnson Egypt is recruiting for a Business Quality Executive be located in Cairo, Egypt.

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.

Sector/Organization Overview

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

Summary of the job:

The QE is responsible for the quality of, and meeting the applicable requirements for, the products and processes at the LOC markets, or the products that it produces for other companies (including all named-patient materials, product samples and/or clinical supplies).

He is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GXP activities the LOC undertakes. In this role he has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Market Quality Manual.

Duties & Responsibilities

1.1 MAIN ACTIVITIES/TASKS:

Quality Systems

  • Implement the Quality System via transposition of the requirements of the Business Quality Manual (BQM).

  • Maintain an up to date list of all relevant product sourcing, supply routes (including exports), product licences (marketing authorizations), relevant authorizations (e.g. manufacturing, packaging, importation, warehousing, distribution, testing, narcotics handling, etc.) as per BQM.

  • Prepare, update and approve LOC procedures in accordance with local GxP, BQM and J&J requirements.

  • Execute minimum requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity.

  • Ensure the provision of appropriate training for all job functions with GxP responsibilities and maintain the training matrix.

  • Ensure appropriate change control systems are in place and are followed and effectively closed on time.

  • Manage the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into the CURVE.

  • Monitor quality system performance versus local GxP, BQM and J&J requirements via use of pertinent business and compliance metrics and goals.

  • Drive continuous improvement in the Quality System using quality system performance information, in conjunction via periodic internal audits, deviation management, CAPA management and performance reviews.

  • Timely notify and engage LOC Quality Head and Business Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in BQM.

Quality Processes

  • Ensure that robust processes are installed and maintained to ensure accuracy of printed packaging (labelling) text, including correct translation from source documents into local product text versions and appropriate review at critical stages, and that all people involved in text management have been trained accordingly.

  • Ensure all suppliers and distributors are appropriately managed and qualified, and required agreements are in place, reviewed and updated as needed.

  • Maintaining a robust system to ensure product transportation, storage and receipt was done according to J&J requirements and that products are assessed and released to the market.

  • Ensure transportation temperature excursions are properly assessed as per J&J requirements and relevant quality records are issued to investigate and asses them.

  • Implement a robust process to receive and evaluate all returned goods before rejecting or re-issuing the goods.

  • Conduct regular (self-)inspections of GxP practices that are applicable - within the responsibilities of the Local Operating Company.

  • Ensure product and AE complaints and efficiently, escalate critical product issues and conduct recalls and other field actions in a timely manner (including outside business hours, plus QE backup in every case of absence).

  • Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, the logistic department and any other functions supporting complaint management.

  • Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.

  • Support and perform audits on suppliers and distributors when needed as per Johnson & Johnson Quality Policy to ensure J&J requirements are effectively in place.

Main performance measures (Performance Goals)

  • Maintaining a green quality matrix and KPIs and ensuring all quality records are effectively closed on time.

  • Proactively work on improving the quality systems.

Qualifications

Experience Required

  • Education: BSc in Pharmacy or relevant

  • Years of Experience: 2 - 4

  • Language: Arabic and English

  • Location: Egypt

  • Relocation availability: NA

Leadership Behaviors Required

  • LIVE OUR CREDO: Demonstrate and inspire the behaviors that reinforce Our Credo.

  • CONNECT: Develop deep insights into the needs of our patients, customers, markets and communities.

  • SHAPE: Drive innovation; anticipate and shape industry and market changes to advance health care globally.

  • LEAD: Create an environment where leadership and talent development is top priority.

  • DELIVER: Deliver results by inspiring and mobilizing people and teams.

Technical/Functional Skills Required

  • Experience in the Pharmaceutical industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management.

  • Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes.

  • Knowledge and experience with Trackwise is a plus.

  • Up-to-date knowledge of relevant pharmaceutical legislation and cGXP

  • Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.

Primary Location

Egypt-Cairo-Cairo-

Organization

Janssen Egypt (7804)

Job Function

Quality Assurance

Requisition ID

1805704891W