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.

Essential duties and responsibilities:

Quality Systems:

·       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...