Commercial Quality Executive KSA & Gulf

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations:

Cairo, Egypt

Job Description

J&J Innovative Medicine is recruiting for a Commercial Quality Executive KSA & Gulf to be based in Egypt.

Overall Purpose Of Job

Commercial Quality Executive (QE) is responsible for the quality of, and meeting the applicable requirements for, the products and processes at the LOC markets, QE 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/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Quality Manual.

Quality Systems

Essential duties and responsibilities:

• Implement the Quality System via transposition of the requirements of the Commercial Quality Manual (BQM)
• 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.
• Monitor quality system performance versus local GxP, CQM and J&J requirements via use of pertinent business and compliance metrics and goals.
• Timely notify and engage LOC Quality Head and Commercial Quality team and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in CQM.
• Ensure activities are carried out in compliance with the specific requirements applicable to controlled substances
  
  

Quality Processes

• 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.
• Ensure product and AE complaints and efficiently, escalate critical product issues and conduct recalls and other field actions in a timely manner
• 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.
• Proactively work on improving the quality systems.
• Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP, including any legislation/guidelines relating to controlled substances”.
  
  

Requirements

• Education: BSc in Pharmacy or relevant
• Years of Experience: minimum of 3 years’ experience in Quality System , preferably with manufacturing background
• Language: Arabic and English
  
  

Essential Knowledge And Skills

The Commercial Quality Talent should meet the following knowledge, experience and skills:

• Understanding of Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management, Regulatory Affairs and some Sales & Marketing experiences. Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), Manufacturing / QA operations experience is essential;
• Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
• Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;
• Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
  
  

Willing to understand J&J Quality Policy, and the procedures and processes outlined in Quality Manual.

Core Competencies Required For This Role

• Proficiency in operating PC, PowerPoint and in using Microsoft Word,
• Strong analytical Excel skills (Pivot Tables, If statements, VLOOKUP’s)
• Knowledge in business intelligence tool (Voyager)
• Proficiency in using Commet, Product Quality Complaint Tool